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The following safety alerts has a reasonable chance that the product will cause serious health problems or death. These cases will be forming part of the summary of July 2009 and more details will be provided when available

*Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada

MDCO Ref. No. Description of Product Source of Information* Reference No. by Source Alert Type by Source

Bausch & Lomb Boston Conditioning Solution Original Formula N.A. Firm Initiated Field Action 2009/07/02

Medtronic International Ltd. N.A. Firm Initiated Field Action 2009/07/06

Boston Scientific Flexima Biliary Catheter System N.A. Firm Initiated Field Action 2009/07/08

Respironics BiPAP Focus Noninvasive Ventilator System Z-1606-2009 Class I 2009/07/09

BD N.A. Firm Initiated Field Action 2009/07/09

N.A. MDA 2009/07/10

Medtronic International Ltd. MDA/2009/043 Firm Initiated Field Action 2009/07/10

Medtronic International Ltd. N.A. Firm Initiated Field Action 2009/07/10

Boston Scientific LeVeen Needle Electrodes - 5.0cm N.A. Firm Initiated Field Action 2009/07/10

Welch Allyn AED 10 and MRL JumpStart Defibrillators Welch Allyn N.A. Firm Initiated Field Action 2009/07/21

Major Safety Alerts in July 2009 (This page is subject to further review)

Date of Issue (YYYY/MM/DD)

Bausch & Lomb (Hong Kong ) Ltd

Medtronic SynchroMed II (Model 8637) Implantable Drug Infusion Pump Battery Performance

Boston Scientific Hong Kong Ltd

FDA

BD 60ml Lurt-Lok Syringes (Recorder Number 309653; Lot No.: 819101A)

Boston Scientific Flexima and Percuflex drainage catheter family (pigtail style, peripheral interventions), Percuflex and percutaneous model drainage catheter family (urology)

MHRA

Medtronic Model 8551 sYNCHROmED Refill Kits w/ reversed UBD and Mfg Dates

Medtronic QUICK-SET INFUSION SETS Models MMT-396, MMT-397, MMT-398 and MMT-399


http://www.fda.gov/Safety/Recalls/EnforcementReports/ucm170893.htm

http://www.mhra.gov.uk/Publications/Safetywarnings/MedicalDeviceAlerts/CON051829


Local Agent

2213 3371

Medtronic International Ltd. 2919 1362

Boston Scientific Hong Kong Ltd 2960 7136

Celki Medical Company 2268 9258

BD 2575 8668





Welch Allyn N,A,

Agent Contact Telephone No.

Bausch & Lomb (Hong Kong ) Ltd

Medical Device Control Office 3 Department of HealthThe Government of HKSAR

Monthly Summary of Medical Device Safety Alerts - June 2009*Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada


SN090601 Hologic Discovery and Explorer X-ray Bone Densitometer Systems 2009/004/029/061/013 FSCA 2009/06/01

SN090602 CME McKinley T34 Syringe Driver 2009/004/028/291/009 FSCA 2009/06/01

SN090603 GE Signa Ovation systems with CTL Array, XL Body Flex and Open Body Coils 2009/003/012/061/013 FSCA 2009/06/01

SN090604 ThermoFisher Scientific Salmonella Chromogenic medium PO0958A 2009/005/008/601/004 FSCA 2009/06/01

SN090605 DePuy PFC Sigma Cruciate Retaining Non-Porous Size 5 Left Femoral Component 2009/005/014/081/001 FSCA 2009/06/01

SN090606 KeyMed, Olympus, Aloka WM-NP1 (Workstation) 2009/005/007/061/003 FSCA 2009/06/01

SN090607 Stryker Triathlon TS Knee System Offset Adapter Trial 2009/005/013/081/011 FSCA 2009/06/01

SN090608 2009/005/014/081/003 FSCA 2009/06/01

SN090609 Moria Evolution 3E 2009/003/023/401/006 FSCA 2009/06/01

SN090610 Welch Allyn Vital Signs Monitor VSM 300 2008/012/005/601/002 FSCA 2009/06/01

SN090611 Aerocrine NIOX and NIOX Flex, 03-1000 resp 03-1000-F 2009/005/014/051/012 FSCA 2009/06/01

SN090612 Siemens Medical Acuson X300 System with Swiftlink Connector DL260 2009/005/014/081/012 FSCA 2009/06/01

SN090613 Medical Devices Group Computer treatment planning 2009/005/017/601/002 FSCA 2009/06/01

SN090614 Smith & Nephew Legion Pressfit Stems 71424053 & 71424043 2009/004/016/051/009 FSCA 2009/06/01

SN090615 Stryker Mantis Rod Inserter Shaft 2009/005/006/061/001 FSCA 2009/06/01

SN090616 ThermoFisher PB0378A 2009/005/006/601/001 FSCA 2009/06/01

SN090617 ThermoFisher PO1110A 2009/005/006/601/002 FSCA 2009/06/01

SN090618 Roche Diagnostics Elecsys Folate III 2009/004/029/061/008 FSCA 2009/06/01

SN090619 Merit Medical Systems Prelude Short Sheath Introducer 2009/004/024/051/002 FSCA 2009/06/01

SN090620 CalMed Op-Flex Poole (Handle Set) contained within Procedure Packs 2009/005/014/291/013 FSCA 2009/06/01

SN090621 Siemens Medical ACUSON Sequoia, auxiliary CW transducer 2009/005/014/081/013 FSCA 2009/06/01

SN090622 45746 Type II 2009/06/02

SN090623 47966 Type II 2009/06/02

SN090624 CMS Focal Software CD 48015 Type II 2009/06/02

SN090625 Immucor Gallileo Echo Blood Analyzer (Model 87000) 47888 Type II 2009/06/02


MHRA

MHRA

MHRA

MHRA

MHRA

MHRA

MHRATeleflex Medical (Athlone) Arrow 12 French Triple-Lumen 20cm & 16cm Large-Bore Central Venous Catheters MHRA

MHRA

MHRA

MHRA

MHRA

MHRA

MHRA

MHRA

MHRA

MHRA

MHRA

MHRA

MHRA

MHRA

Medmont E300 Corneal Topographer, DV2000 Digital Imaging Software and M700 Automated Perimeter Health Canada

Ethicon (JNJ) Endopath Endoscopic Linear Cutters (Model # LONG45A; ATB45, ATW45; NAW45) Health Canada

Health Canada

Health Canada

http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/FieldSafetyNoticesformedicaldevices/CON046491





















http://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/_list/rec-ret_md-im_date_apr-june_2009-eng.php





SN090626 FisherDiagnostics Infinity Glucose Hexokinase Reagent (Catalog # TR15498) 47989 Type II 2009/06/02

SN090627 Premier Dental Integra CEM (Model# 3001410) 48059 Type II 2009/06/02

SN090628 Leckey Four-point Pelvic Harness (Model no 122-719) 47922 Type II 2009/06/02

SN090629 47380 Type II 2009/06/02

SN090630 Beckman Coulter Synchron Systems Ammonia (AMM) Reagent (Model#439770) 47835 Type II 2009/06/02

SN090631 Sonomed Vumax Ophthalmic Ultrasound Scanner (Model#SHFS35-S) 47987 Type II 2009/06/02

SN090632 Boston Scientific Contak Renewal 4 CRT-D and Vitality 2 Acid 47031 Type II 2009/06/02

SN090633 MEDEX SBI Injector 2009/003/010/601/001 FSCA 2009/06/03

SN090634 Promotal SAS Quest and Duolys exam couches and Ambéo, 3181 and 3185 chairs 2009/005/011/291/012 FSCA 2009/06/03

SN090635 GE Healthcare Definium 5000 digital X-ray systems 2009/005/007/051/002 FSCA 2009/06/03

SN090636 Siemens Medical Symbia S and Symbia T 2009/003/016/291/004 FSCA 2009/06/03

SN090637 Marflow AG - Medical Equipment Grabit 3 prong grasping forcep 2009/002/027/401/005 FSCA 2009/06/03

SN090638 Corin Uniglide Unicondylar Knee - femoral component 2009/004/023/061/002 FSCA 2009/06/03

SN090639 Varian Clinacs with C Series version 7.x and the SRS Motion Disable Option N.A. Firm Initiated Field Action 2009/06/03

SN090640 Depuy (JNJ) Knee Replacement Implant MDA/2009/037 MDA 2009/06/04

SN090641 Arjo Maxilift 2009/004/016/261/001 FSCA 2009/06/05

SN090642 Beckman Coulter AutoMate Sample Processing Systems 2009/005/014/601/001 FSCA 2009/06/05

SN090643 BD Syringe 10ml Luer-Lok BD N.A. Firm Initiated Field Action 2009/06/05

SN090644 GE Healthcare ApexPro Telemetry System Z-1227-2009 Class II 2009/06/08

SN090645 Alcon 25 GA Total Plus Pak and Vitrectomy 25 GA Custom Pak Z-1412-2009 to Z-1413-2009 Class II 2009/06/08

SN090646 Z-1414-2009 Class II 2009/06/08

SN090647 Abbott ARCHITECT Reaction Vessel (List no 7C15-01) Z-1398-2009 Class II 2009/06/08

SN090648 Z-1398-2009 Class II 2009/06/08

SN090649 Z-1399-2009 Class II 2009/06/08

SN090650 MEDRAD Sterile Disposable Syringe Kit (Catalog. no DSK 130-Q) Z-1228-2009 Class II 2009/06/08

SN090651 Synthes Spine Square Nut MR Safe (Catalog no. 03.311.060) Z-1324-2009 Class II 2009/06/08

Health Canada

Health Canada

Health Canada

Sunrise Mobility Quickie LXI Manual Wheelchair (Model# LXI-034741, LXI-034609, LXI-034740, LXI-034500) Health Canada

Health Canada

Health Canada

Health Canada

MHRA

MHRA

MHRAMHRA

MHRA

MHRA

Varian Medical Systems Pacific Inc.

MHRA

MHRA

MHRA

FDA

FDA

Kimberly-Clark Synthetic Powder Free Vinyl Exam Gloves (Size: S, M and L) (Cat. No. 55031, 55032, 55033) FDA

FDA

Abbott Cell-Dyn Ruby Hematology Analyzer with System Softare Version 2.0ML (List no. 08H67-01) FDA

Siemens Medical Immulite 2000 and Immulite 2500 digital Fluidics PC Board (Part no. 450116-0002) FDA

FDA

FDA














http://www.mhra.gov.uk/Publications/Safetywarnings/MedicalDeviceAlerts/CON049039?tabName=Distribution












SN090652 Z-1248-2009 to Z-1249-2009 Class II 2009/06/08

SN090653 Argon Medical Devices ArgoGuide Hydrophilic NiTi Guidewire Z-1267-2009 to Z-1307-2009 Class II 2009/06/08

SN090654 Zimmer TM-400 Broach Handle 2009/005/011/291/010 FSCA 2009/06/08

SN090655 AGA Medical Amplatzer Cardiac Plug 2009/002/018/291/006 FSCA 2009/06/08

SN090656 Zimmer TransFx External Fixation System drill bit, quick connect 2009/005/007/061/017 FSCA 2009/06/08

SN090657 Ortho-Clinical Diagnostics Veridex LLC CellTracks AutoPrep System 2009/005/012/081/014 FSCA 2009/06/08

SN090658 2009/004/002/601/001 FSCA 2009/06/08

SN090659 Siemens Medical Immulite 2000 / Immulite 2500 Chemiluminescent Substrate Module 2009/005/027/081/003 FSCA 2009/06/08

SN090660 Trinity Biotech TriniCAL Reference Plasma and TriniCHECK Control Levels 1, 2 & 3 2009/005/027/291/008 FSCA 2009/06/08

SN090661 Beckman Coulter UniCel DxC 880i, 860i, 680i & 660i Synchron Access Clinical Systems 2009/005/021/601/001 FSCA 2009/06/09

SN090662 Invacare Harrier Plus, HD & XHD 2007/005/024/061/002 FSCA 2009/06/09

SN090663 Philips Synergy Flex-M / Shoulder Coil 2009/005/028/051/005 FSCA 2009/06/09

SN090664 Mölnlycke Phaco Pack Shepton Mallet JAV 17177 2009/005/029/081/003 FSCA 2009/06/09

SN090665 Gambro Hong Kong Ltd N.A. Firm Initiated Field Action 2009/06/10

SN090666 Allergan Medical FloWatch-PAB 2009/005/028/051/010 FSCA 2009/06/11

SN090667 GE Healthcare Innova 2100IQ, 3100, 3100IQ, 4100, 4100IQ, 2121IQ & 3131IQ 2009/006/002/081/006 FSCA 2009/06/11

SN090668 Tosoh Bioscience Hemoglobin F&A2 control set 2009/005/014/051/010 FSCA 2009/06/11

SN090669 Trinity Biotech TriniCLOT aPPT HS 2009/005/022/081/001 FSCA 2009/06/11

SN090670 EBI Titanium Cannulated Screws and Bone Screws 2009/004/024/601/004 FSCA 2009/06/11

SN090671 Philips MD Allura FD 2009/006/003/291/017 FSCA 2009/06/12

SN090672 Varian Eclipse Treatment planning System, version 8.6 and earlier (Product Code: H48) N.A. Firm Initiated Field Action 2009/06/12

SN090673 Z-1349-2009 to Z-1351-2009 Class II 2009/06/15

SN090674 Stryker Surgical Table Headrest (Catalog/Part # 0788-300-012) Z-1418-2009 Class II 2009/06/15

SN090675 Terumo Advanced Perfusion System 1 Central Control Monitor (Catalog no 802100) Z-1224-2009 Class II 2009/06/15

SN090676 Z-1352-2009 to Z-1353-2009 Class II 2009/06/15

Synthes Spine InSitu Bender Cutter Kit Wide Sterile (Cat. No. 530.521S) and InSitu Bender Cutter Kit Narrow Sterile (Cat. No. 530.522S) FDA

FDA

MHRA

MHRA

MHRA

MHRA Biomet Microfixation Arthrosimplicity and OnPoint Scope kits, Becton Dickinson syringe component MHRA

MHRA

MHRA

MHRA

MHRA

MHRA

MHRAGambro AK200 S equipped with UFD and AK 200 ULTRA S in combination with BiCart Select

MHRA

MHRA

MHRA

MHRA

MHRA

MHRAVarian Medical Systems

Pacific Inc.

Stryker Gamma3 Plus Obese Targeting System, Gamma3S Trochanteric Nail 170 and Gamma 3 FDA

FDA

FDA

Biomet Dual Offset Broach Handle, Clamping Style, Left (REF 31-555403) and Right (REF 31-555404) FDA




















http://www.fda.gov/downloads/Safety/Recalls/EnforcementReports/UCM166251.pdf





SN090677 Spectranetics SLS II Lasr Sheath Kit, 14F (REF 500-012) Z-1264-2009 Class II 2009/06/15

SN090678 Varian CLINAC Software Versions 6.X and 7.X (Remote Auto Motions) N.A. Firm Initiated Field Action 2009/06/15

SN090679 Zimmer Nexgan LPS and Nexgen LPS-Flex Femoral Components 48206 Type II 2009/06/15

SN090680 Roche PSM with Validation Module (Model# 03009696001, 03265439001) 47890 Type II 2009/06/15

SN090681 Abbott i-STAT 1 Analyzer System-Instrument (Model/Catalog # 06F16-10) 48245 Type II 2009/06/15

SN090682 Stryker Austin Moore Stems - Curved 43mm (Model/Catalog# 6939-0-430) 48207 Type II 2009/06/15

SN090683 Siemens Acuson S2000 VA10 (Model / Catalog# 10041461) 48077 Type II 2009/06/15

SN090684 47349 Type II 2009/06/15

SN090685 Medline Penrose Drain 48072 Type II 2009/06/15

SN090686 Ansell Healthcare Derma Prene Ultra Surgical Glove (Model/Catalog # 851365 / 851470) 48229 Type II 2009/06/15

SN090687 Motion Concepts Tilt/Elevating Seating System and Tilt/Elevate/Recline Seating System 46283 Type II 2009/06/15

SN090688 Walter Lorenz Surgical (Biomet Microfixation) Dean Scissors (Model: 09-0142) 47701 Type II 2009/06/15

SN090689 Viewsonic VGM 19" Monitor 48079 Type II 2009/06/15

SN090690 Roche Accu-chek Performa N.A. Firm Initiated Field Action 2009/06/16

SN090691 Abbott POWERSAIL Coronary Dilatation Catheter Abbott Laboratories LTD. N.A. Firm Initiated Field Action 2009/06/16

SN090692 ThermoFisher PO0171A brilliant green agar 2009/006/004/601/002 FSCA 2009/06/17

SN090693 Heliosphere Bag Intragastric Balloon MDA/2009/040 MDA 2009/06/19

SN090694 GE Healthcare Ge Signa Hdx 3T MR Systems, Ge Signa Hdxt 3T MR Systems 2009/006/008/291/012 FSCA 2009/06/19

SN090695 Edwards Lifesciences Introflex Tuohy-Borst Valve Introducer 2009/005/028/051/012 FSCA 2009/06/19

SN090696 2009/006/002/051/003 FSCA 2009/06/22

SN090697 Philips CareVue Chart Release C.O. (Part Number 862246) Z-1436-2009 Class II 2009/06/22

SN090698 Synthes Zero-P StarDrive Screwdriver Shaft, T8 (Catalog# 03.617.902) Z-1348-2009 Class II 2009/06/22

SN090699 Innovative Neurotronics WalkAide Stimulator System Control Module (Part No. 20-0100) Z-1435-2009 Class II 2009/06/22

SN0906100 Z-1244-2009 Class II 2009/06/22

SN0906101 BD Beaver Arthro-Lok Pointed Tip 4mm Blade (Cat no. 376780) BD N.A. Firm Initiated Field Action 2009/06/22

FDAVarian Medical Systems

Pacific Inc.

Health Canada

Health Canada

Health Canada

Health Canada

Health CanadaCook Zenith Renu AAA Converter, Zenith Renu AAA Main Body and Zenith AAA Main Body Bifurcated Stent Health Canada

Health Canada

Health Canada

Health Canada

Health Canada

Health CanadaRoche Diagnostics (Hong

Kong) Ltd

MHRA MHRA

MHRA

MHRA

Ortho-Clinical Diagnostics VITROS 3600 immunodiagnostic system, VITROS 5600 integradeted system MHRA

FDA

FDA

FDA

TEVA Medical Device TEVADAPTOR Closed Drug Reconstitution and Transfer System (Model no. MG412110) FDA























SN0906102 Cemma Enterprise Co., Ltd N.A. Firm Initiated Field Action 2009/06/22

SN0906103 Select Healthcare Locomotor lifting slings for adults and children MDA/2009/041 MDA 2009/06/23SN0906104 Philips Avalon Fetal Monitor 2009/006/010/291/016 FSCA 2009/06/23

SN0906105 Boston Scientific Resolution Clip N.A. Firm Initiated Field Action 2009/06/22

SN0906106 2009/005/013/081/008 FSCA 2009/06/24

SN0906107 Terumo Advanced Perfusion System 1 (Catalog no 802100) 46444 Type II 2009/06/25

SN0906108 47925 Type II 2009/06/25

SN0906109 GE Healthcare AW Volumeshare2 - Software Options (Model# B79011MA) 45984 Type II 2009/06/25

SN0906110 Stryker Vertier Table Headrest Attachment (Model # 0788-300-012) 48498 Type II 2009/06/25

SN0906111 ACIST Angiographic System - Manifold Kit (Model # BT2000) 48480 Type II 2009/06/25

SN0906112 CMS XIO Radiation Treatment Planning System 48447 Type II 2009/06/25

SN0906113 R&D Systems Quantikine IVD Human B2-Microglobulin (Lot # 260980) 48674 Type II 2009/06/25

SN0906114 MedovationsInsufflation Tubing With Filter (Model no SU1101) 48488 Type II 2009/06/25

SN0906115 Medical Devices Group Computer treatment planning release 4.34.00 through 4.40.00 2009/006/011/601/001 FSCA 2009/06/25

SN0906116 2009/006/008/291/014 FSCA 2009/06/25

SN0906117 2009/006/008/291/013 FSCA 2009/06/25

SN0906118 PENTAX Suction Valve (Types, Of-B136, Of-B140, Of-B163, Of-B179 in endoscopy) 2009/005/020/291/005 FSCA 2009/06/25

SN0906119 Siemens Mavig Portegra 2 Z-1437-2009 to Z-1443-2009 Class II 2009/06/26

SN0906120 Z-1419-2009 to Z-1420-2009 Class II 2009/06/26

SN0906121 Z-1416-2009 Class II 2009/06/26

SN0906122 Bard E LUMINEXX Biliary Stent Z-1453-2009 to Z-1469-2009 Class II 2009/06/26

SN0906123 GE Signa Ovation 0.35T, GE Signa Openspeed 0.7T 2009/006/002/081/003 FSCA 2009/06/26

SN0906124 Terumo pre-connected haemoconcentrator with drainage bag (adult or paediatric) 2009/006/009/081/006 FSCA 2009/06/26

SN0906125 Siemens Advia Centaur Hepatitis B Core Total (HBcT) Assay 2009/006/011/291/002 FSCA 2009/06/26

SN0906126 Ormesa New Bug 2008-011-013-301-001 FSCA 2009/06/26

SN0906127 Ethicon (JNJ) Endoloop Ligature Pds II Suture 2009/006/012/291/005 FSCA 2009/06/29

SN0906128 DxS Therascreen: EGFR29 Mutation Kit 2009/005/028/051/014 FSCA 2009/06/29

Arrow International Pediatric Two-Limen Central Venous Catheterization Set with Blue FlexTip Catheter (Cat no. CS-14502)

MHRA MHRA


Philips Respironics MicroElite Nebulizer Compressors (Medel Product No. 91709 to 91716, Respironics Product No. 1053626, 1053677 to 1053683) MHRA

Health CanadaBard Vacora Vacuum Biopsy System (Model# VC10118P) and Vacora Vacuum Biopsy System-Cannula (Model# VC10118MR) Health Canada

Health Canada

Health CanadaHealth CanadaHealth Canada

Health Canada

Health Canada

MHRA

Siemens Artiste digital linear accelerators with syngo RT Therapist version 4.1 connected to LANTIS MHRA

Siemens Artiste digital linear accelerator with syngo RT Therapist Version 4.1 build 67 and build 122 MHRA

MHRA

FDA

Advanced Sterilization Products (JNJ) STERRAD 50 Sterilization System (Product Code 10050) and STERRAD NX Sterilization System (Prodoct Code 10033) FDA

Cook Medical Tao Brush I.U.M.C. Endometrial Cytology/Histology Sampler (REF J-ES-090500-BL) FDA

FDAMHRA

MHRA

MHRAMHRAMHRA MHRA



























SN0906129 ThermoFisher Scientific PO0287A Yersinia Agar (CIN Med) FSCA 2009/06/29

SN0906130 Possum HC603C IR Mains Switch 2009/004/023/301/001 FSCA 2009/06/29

SN0906131 Maquet Servo 300 ventilator (SV300) MDA/2009/042 MDA 2009/06/30

MHRA 2009/006/017/601/003, 2009/006/024/601/001

MHRA MHRA





Local Agent

N.A. N.A.

N.A. N.A.

GE Medical Systems Hong Kong Ltd. 2783 1838

N.A. N.A.

N.A. N.A.

N.A. N.A.

Stryker China Ltd 2518 6915

N.A. N.A.

N.A. N.A.

N.A. N.A.

N.A. N.A.

Siemens Healthcare Diagnostic Limited 2810 7533

N.A. N.A.

N.A. N.A.

N.A. N.A.

N.A. N.A.

N.A. N.A.

Roche Diagnostics (Hong Kong) Ltd 2485 7510

King Health Limited 2481 3787

N.A. N.A.


Park World Development Ltd 2880 9689

N.A. N.A.

N.A. N.A.

Uninet Technology LTD 2838 8423

Agent Contact Telephone No


N.A. N.A.

N.A. N.A.

Otto Bock Asia Pacific Limited 2598 9772

N.A. N.A.

Beckman Coulter Hong Kong Ltd 2240 6150

N.A. N.A.


N.A. N.A.

N.A. N.A.

N.A. N.A.


N.A. N.A.

N.A. N.A.

Varian Medical Systems Pacific Inc. 2724 2836

Johnson & Johnson Medical (HK) 2738 6027

ArjoHuntleigh (Hong Kong) Ltd 2508 9553


BD 2575 8668


Alcon Hong Kong Ltd 2568 0636

Kimberly-Clark (Hong Kong) Limited 2334 3361

Abbott Laboratories LTD. 2593 2211



Medrad Asia Pte.Ltd 65-6752 5318

Synthes (Hong Kong) Ltd 2724 2032



N.A. N.A.

Zimmer PTE Ltd. (Hong Kong branch) 2992 0968

N.A. N.A.


Ortho Clinical Diagnostics 2737 5504

N.A. N.A.


N.A. N.A.


N.A. N.A.

Philips Health Care (Great China) 2821 5480

N.A. N.A.

Gambro Hong Kong Ltd 2839 9710

N.A. N.A.


N.A. N.A.

N.A. N.A.

N.A. N.A.





TERUMO CHINA (H.K.) LTD. 2866 0811

N.A. N.A.


N.A. N.A.







N.A. N.A.

N.A. N.A.

N.A. N.A.

N.A. N.A.

N.A. N.A.

ViewSonic Hong Kong 3690 1398



N.A. N.A.

N.A. N.A.


N.A. N.A.

Ortho Clinical Diagnostics N.A.



N.A. N.A.

N.A. N.A.

BD 2575 8668


Cemma Enterprise Co., Ltd 2412 2310

N.A. N.A.N.A. N.A.




N.A. N.A.



N.A. N.A.

N.A. N.A.

N.A. N.A.

N.A. N.A.

N.A. N.A.



N.A. N.A.


Johnson & Johnson Hong Kong Ltd 2738 6027

AR Burkill & Sons (HK) Ltd 2541 1041

N.A. N.A.




N.A. N.A.


N.A. N.A.


N.A. N.A.

N.A. N.A.

N.A. N.A.


Monthly Summary of Medical Device Safety Alerts - May 2009*Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada


SN090501 Roche ACCU-CHEK Spirit Insulin Pump N.A. Press Release 04-May-09

SN090502 Accuray Synchrony Respiratory Tracking System 2009/004/017/061/012 FSCA 04-May-09

SN090503 Sunrise Medical Breezy 100 and Breezy 300 2008/006/025/261/001 FSCA 04-May-09

SN090504 Elekta XVI (Synergy® kV Detector) 2009/003/011/061/002 FSCA 04-May-09

SN090505 Great Bear cubCATH Intermittent Catheter AVP10 2009/003/025/061/007 FSCA 04-May-09

SN090506 Maquet MEDAP BORA UP 2080 Universal suction pump 2009/003/025/061/017 FSCA 04-May-09

SN090507 Nucletron Oncentra Prostate CT/MR option 2009/004/022/291/006 FSCA 04-May-09

SN090508 Medtronic Sprinter OTW Product (TPL 970) Medtronic International Ltd N.A. Firm Initiated Field Action 05-May-09

SN090509 Stryker PainPump2 Z-1182-2009 to Z-1194-2009 Class II 07-May-09

SN090510 Cardinal Health Alaris Patient-Controlled Analgesia (PCA) Module (Model 8120) Z-1237-2009 Class II 07-May-09

SN090511 Siemens Syngo Imaging (Model# 10 014 063) Z-1235-2009 Class II 07-May-09

SN090512 Tri-State Centurion Products Z-1319-2009 to Z-1322-2009 Class II 07-May-09

SN090513 Wright Medical Screwdriver for 3.5mm Screws (DARCO System, REF: DC4261) Z-1208-2009 Class II 07-May-09

SN090514 Hill-Rom TotalCare Bed (Model P1900) Z-1317-2009 Class II 07-May-09

SN090515 Medtronic Model 37085 Restore 1x4 DBS Extension Kit Medtronic International Ltd N.A. Firm Initiated Field Action 07-May-09

SN090516 Smith & Nephew Blades Smiths & Nephew Ltd N.A. Firm Initiated Field Action 07-May-09

SN090517 Invacare XLT Self Propelling Wheelchair with rear wheels set back - anti tipper 2008/011/010/061/017 FSCA 08-May-09

SN090518 Biosite Triage Cardiac Panel Z-1391-2009 Class I 11-May-09

SN090519 Boston Scientific Safety and Standard Push PEG Kits N.A. Firm Initiated Field Action 11-May-09

SN090520 Boston Scientific Neuroform3 Microdelivery Stent System N.A. Firm Initiated Field Action 11-May-09

SN090521 Smith & Nephew Reflection Microstable Acetabular Liner (REF 71740250) Smiths & Nephew Ltd Z-1004-2009 Firm Initiated Field Action 11-May-09

SN090522 BD Insuline Syringe (Cat no. 328420) BD N.A. Firm Initiated Field Action 13-May-09


FDA

MHRA

MHRA

MHRA

MHRA

MHRA

MHRA

FDA

FDA

FDA

FDA

FDA

FDA

MHRA

FDA



http://www.fda.gov/oc/po/firmrecalls/disetronic04_09.html







http://www.fda.gov/bbs/topics/ENFORCE/2009/ENF01106.html







http://www.fda.gov/cdrh/recalls/recall-042709.html


SN090523 Molift Smart 2009/001/020/301/001 FSCA 13-May-09

SN090524 ThermoFisher TPHA Test Kit. 2009/004/028/061/014 FSCA 13-May-09

SN090525 Cordis Cypher Select Sirolimus Eluting Coronary Stents (Hub Crack) N.A. Firm Initiated Field Action 13-May-09

SN090526 Siemens Mammomat Novation DR (Model No. 06646900) Z-1233-2009 Class II 14-May-09

SN090527 GE Healthcare CIC Pro" Software Versions 5.0.3, 5.0.6, 5.0.7, 5.0.8 and 4.1 Z-1232-2009 Class II 14-May-09

SN090528 Z-1328-2009 Class II 14-May-09

SN090529 N.A. Firm Initiated Field Action 15-May-09

SN090530 47695 Type II 14-May-09

SN090531 47576 Type II 14-May-09

SN090532 47581 Type II 14-May-09

SN090533 47734 Type II 15-May-09

SN090534 Norwex Silvercare Toothbrush (Model: 22963) 47238 Type II 15-May-09

SN090535 Spacelabs Medical Medical Flat Panel Power Supply (Model: 010-1619-00, 010-1655-00) 47582 Type II 15-May-09

SN090536 Beckman Coulter Flow-set Fluorospheres (Model: 6607007) 47347 Type II 15-May-09

SN090537 Biomet Orthopedics C2A Ringloc Acetabular System - 28 mm (Model: 12-115112) 47389 Type II 15-May-09

SN090538 Biomet Microfixation Byrd Screw 2.0x6mm Self Drilling (Model: 01-0267) 46721 Type II 15-May-09

SN090539 Bard Max-Core Disposable Bipsy Instr. (Model: MC1810, MC1816, MC1820) 47251 Type II 15-May-09

SN090540 Beckman Coulter Access Systems Total BHCG Reagent Kit (Model: 33500) 47348 Type II 15-May-09

SN090541 46908 Type II 15-May-09

MHRA

MHRAJohnson & Johnson Medical

(HK)

FDA

FDA

Nova Biomedical Stat Profile Critical Care Xpress (CCX and CXX+), CCX Creatinine Membrane Kit for CCX analyzer (Catalog # 35238) FDA

Varian 4DITC Version 8.1x or Varian Treatment (VT) for Elekta, Siemens and GE Saturne Linacs Versions 6.6.5046 and 6.6.5048 with ARIA Server versions 8.1.15, 8.5.11 and 8.6.07


Bard Truguide Coazial Biopsy Needle (Model: C4140A, C1810B, C1813B, C1816B, C1820B, C2013B, C2016B, C2020B) Health Canada

Stryker Restoration Modular Cone Bodies (Model: 6276-1-121, 6276-1-125, 6276-1-219, 6276-1-325) Health Canada

Boston Scientific Percutaneous combination stent (Model: 410-111, 112, 126, 202-207, 304-305) Health Canada

UNOMEDICAL Paradigm Silhouette Infusion Set (Model: MMT-377600, 378600, 381600, 382600) Health Canada

Health Canada

Health Canada

Health Canada

Health Canada

Health Canada

Health Canada

Health Canada

Arrow International A) Percutaneous Sheet, B) Central Venous Catheterization Set/Kit, C) Temporary Pacing Catheter, D) Two-lumen Central Catheterization Kit, E) Percutaneous Sheath Introducers Sets, F) Stopcocks, G) Arterial Access Products, H) Thrombolic Device Rotator Drive Unit, I) Tretorola Percutaneous Thombolic Device, J) Percutaneous Sheath Introducer, K) Super Arrow-Flex Percut Sheath Intro, L) Stopcock with Luer Lock, M) Stopcock Manifold, N) Multi-Lumen Percut Sheath Introducer, O) Stopcock with Luer Lock, P) Stopcock with Luer Lock, Q) Blood Administration Sets, R) Extension Sets, S) Trerotola Percut. Thrombolytic Kit

Health Canada



















SN090542 47632 Type II 15-May-09

SN090543 Ace Surgical Supply 5/0 Polyglycolic Acid Absorbable Suture (Model: 34630) 47393 Type II 15-May-09

SN090544 Wallac OYT Neogram Amino Acids Mass Spec Kit 47714 Type II 15-May-09

SN090545 Philips Holter 47704 Type II 15-May-09

SN090546 47750 Type II 15-May-09

SN090547 47789 Type II 15-May-09

SN090548 47936 Type II 15-May-09

SN090549 ALL Models Bioprosthetic Heart valves MDA/2009/032 MDA 18-May-09

SN090550 Medtronic Kappa 600/700/900 Series and Sigma 100/200/300 Series Pacemakers Medtronic International Ltd. N.A. Firm Initiated Field Action 19-May-09

SN090551 Respironics SmartMonitor 2 Infant Apnea Monitor (Models 4002 and 4003) Z-1411-2009 Class I 19-May-09

SN090552 BD 20ml Luer-Lok Syringe (Recorder Number 309661) BD N.A. Firm Initiated Field Action 19-May-09

SN090553 Roche MagNA Pure LC Workstation Z-1255-2009 Class II 21-May-09

SN090554 GE Centricity TriWin Laboratory Information System Z-1397-2009 Class II 21-May-09

SN090555 Varian Acuity (Auto-fit MLC feature) N.A. Firm Initiated Field Action 21-May-09

SN090556 N.A. Firm Initiated Field Action 22-May-09

SN090557 Boston Scientifc FORTE GUIDE WIRE N.A. Firm Initiated Field Action 22-May-09

SN090558 Radiometer Medical ABL800 Flex analyser 2009/004/021/061/004 FSCA 25-May-09

SN090559 ThermoFisher Scientific Columbia Blood Agar PB0122A 2009/004/023/601/001 FSCA 25-May-09

SN090560 Trinity Biotech TriniCLOT aPTT S 2009/004/028/061/018 FSCA 25-May-09

SN090561 Biomet Orthopedics Offset tibial tray adaptor 5.0mm 2009/003/005/601/002 FSCA 25-May-09

SN090562 Unisurge OP-Flex Poole (handle set) contained within Procedure Packs 2009/003/020/061/016 FSCA 25-May-09

SN090563 Integra LifeScience Licox Oxygen Catheter Micro-Probes (models CC1 and CC1.2) 2009/004/024/051/001 FSCA 25-May-09

Medxi Heparin pre-filled syringes (Model: 3706, 3780, 3781, 3786, 3787), Saline pre-filled syringes )3704, 37043, 37043B, 37043B, 37043BNC, 3705C, 3705NC, 3706) Health Canada

Health Canada

Health Canada

Health Canada

B. Braun IV set with Universal Spike, 2 Ultrasite (Model: 352079/CSP152VSL), Primary IV Set with 3 Ultrasite (Model: 352049, 375100) Health Canada

BMH Medical Combi Sling (626002), Sling Deluxe Child (626002C), Sling Mesh Deluxe Child (626002C-M), Sling Deluxe Oversize (626003), Sling Health Canada

Cardiac Pacemakers Cognis CRT-D HE (N106), Cognis CRT-D (N107), Teligen ICD (VR-HE DF1)(E110), Teligen ICD (DR-HE IS-1)(E110) Health Canada

MHRA

FDA

FDA

FDA


Varian Acuity (Changes to Asymmetric and Symmetric Field Axis Properties During Verification Simulation



MHRA

MHRA

MHRA

MHRA

MHRA

MHRA



















SN090564 Oxoid (Ely) ProSpecT Adenovirus R240096 2009/004/023/601/003 FSCA 25-May-09

SN090565 Siemens Dimension Enzymatic Creatinine Flex Reagent Cartridge 2009/004/027/291/022 FSCA 25-May-09

SN090566 Biomet Microfixation Lactosorb Pectus Stabiliser 2009/004/015/601/003 FSCA 25-May-09

SN090567 Trinity Biotech Captia Measles IgM ELISA test kit 2009/004/017/061/009 FSCA 25-May-09

SN090568 Stanmore Implants METS Modular Tumour System 2009/004/009/061/008 FSCA 25-May-09

SN090569 KeyMed, Olympus, Aloka Endoscope - MU-1 2008/012/023/601/003 FSCA 25-May-09

SN090570 Edwards Lifesciences Aquarius systems GEF08200, GEF09500, GEF09600, GEF09700 2009/004/006/291/009 FSCA 25-May-09

SN090571 Z-1393-2009 to Z-1394-2009 Class II 29-May-09

SN090572 GE Innova 2121-IQ/3131-IQ Biplane Cardiovascular Imaging System Z-1195-2009 Class II 29-May-09

SN090573 Bio-Rad Variant II Hemoglobin Testing System with CDM v 4.0 (model no 270-2000) Z-1395-2009 Class II 29-May-09

SN090574 Remel Staphaurex Plus Kit (Catalog. no. R30950102 and R30950201) Z-1400-2009 Class II 29-May-09

SN090575 BD Insyte Autoguard IV Catheter (Cat. No. 381812; Lot no. 8171780) BD N.A. Firm Initiated Field Action 29-May-09

SN090576 Smith & Nephew DYONICS 25 tubeset kits (Cat no. 7211005; 7211006) Smiths & Nephew Ltd N.A. Firm Initiated Field Action 29-May-09

SN090577 Cardinal Health Esteem Blue with Neu-Thera Polyisoprene Surgeon Gloves 2009/005/007/051/005 FSCA 29-May-09

SN090578 Wright Medical Darco Cannulated Hex Driver 2009/003/003/291/016 FSCA 29-May-09

SN090579 Rocialle InHealth Procedure Packs containing Suction Catheter 2009/005/013/291/002 FSCA 29-May-09

MHRA

MHRA

MHRA

MHRA

MHRA

MHRA

MHRA

Roche cobas 6000 analyzer series (including cobas c 501 and cobas e601 modules) Middleware Solutions instrument Manager Standard and Middleware Solutions instrument Manager Server

FDA

FDA

FDA

FDA

MHRA

MHRA

MHRA
















Local Agent


Accuray Asia Ltd 2247 8628

N.A. N.A.

N.A. N.A.

N.A. N.A.

Maquet Hong Kong Ltd 2393 9511

N.A. N.A.



Cardinal Health N.A.


N.A. N.A.

Starry Medical Technology, Ltd 2961 4503

N.A. N.A.


Smith & Nephew LTD 9651 5523

N.A. N.A.

Biosite Incorporated 2855 6883



Smith & Nephew Ltd 2648 7700

BD 2575 8668



N.A. N.A.

N.A. N.A.




N.A. N.A.


N.A. N.A.



N.A. N.A.

N.A. N.A.

N.A. N.A.


N.A. N.A.

N.A. N.A.

N.A. N.A.


N.A. N.A.


N.A. N.A.

N.A. N.A.

N.A. N.A.


B. Braun Medical Hong Kong 2277 6125

Arjo Huntleigh (Hong Kong) Ltd. 2508 1416


N.A. N.A.



BD 2575 8668






N.A. N.A.

N.A. N.A.

N.A. N.A.

N.A. N.A.

N.A. N.A.

N.A. N.A.


Hong Kong South East Chemicals & Instruments Ltd 2802 6333


N.A. N.A.

N.A. N.A.

N.A. N.A.

N.A. N.A.

N.A. N.A.



Bio-Rad Pacific Ltd. N.A.


BD 2575 8668

Smith & Nephew LTD 2648 7700

N.A. N.A.

Starry Medical Technology, Ltd 2961 4503

N.A. N.A.


Monthly Summary of Medical Device Safety Alerts - April 2009*Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada


SN090401 Tri-State Centurion Products N.A. Class I 2009/04/02

SN090402 Roche COBAS c 11 Analyzer with ISE Module option, GMMI No. 04777433001 Z-1009-2009 Class II 2009/04/02

SN090403 Z-1041-2009 Class II 2009/04/02

SN090404 Stryker Impaction Bur Guard REF 2296-301, 2296-300, 0260-901-300 and 5400-300 Z-1052-2009 Class II 2009/04/02

SN090405 Lecia QCA and iQCA software Z-1040-2009 Class II 2009/04/02

SN090406 Z-1042-2009 Class II 2009/04/02

SN090407 Medtronic Physio-Control Bisphasic LIFEPAK® 12 Defibrillator/monitor Medtronic International Ltd N.A. Firm Initiated Field Action 2009/04/02

SN090408 3M No Sting Barrier Film (Model 3346E) 3M N.A. Firm Initiated Field Action 2009/04/03

SN090409 GE Healthcare ViewPoint Image Archiving and Reporting System 2009/001/007/401/004 FSCA 2009/04/06

SN090410 Gas Control Equipment Sabre Therapy Probe Regulator 2009/003/024/291/011 FSCA 2009/04/06

SN090411 CODAN Burette Sets 2009/003/023/291/013 FSCA 2009/04/06

SN090412 Roche Ambulatory insulin infusion pump. Accu-Chek Spirit MDA/2009/024 MDA 2009/04/07

SN090413 Biomet Biolox Delta Ceramic Heads 28mm, +5mm (T1 taper) 2009/003/017/061/004 FSCA 2009/04/07

SN090414 ThermoFisher Columbia blood agar - PB0122A 2009/003/024/601/003 FSCA 2009/04/07

SN090415 GE Healthcare S/5 iCentral and iCentral Client (L-NET05 and L-NETC05) Z-1039-2009 Class II 2009/04/14

SN090416 Stryker Electric Stretcher with the Quick Drop CPR option (Model 1050 and Model 1550) Z-1230-2009 to Z-1231-2009 Class II 2009/04/14

SN090417 Stelkast Dual Taper Wedge Pressed Fit Femoral Component Z-1073-2009 Class II 2009/04/14

SN090418 Zues Scientific Sm ELISA Test System (Product no.: 2Z2831G and 43270CE) Z-1089-2009 Class II 2009/04/14

SN090419 Trumpf Medical ILED Surgical Light (Model no ILED3, ILED5 and ILED5K) Z-1122-2009 Class II 2009/04/14

SN090420 Theragenics Spacers of varying lengths Z-1020-2009 Class II 2009/04/14

SN090421 Johnson and Johnson Ethicon Endo-Surgery Device - Ets-FLEX45 N.A. Firm Initiated Field Action 2009/04/14

SN090422 Tepnel Quick-Type for LIFEMATCH Update CD MHRA 2009/003/026/601/014 FSCA 2009/04/15


FDA

FDA

Bio-Rad Variant II TURBO Hemoglobin Testing System with CDM V 4.0, MODEL NO 270-2600 FDA

FDA

FDA

DiaSorin LIASON ® Chemiluminescence Analyzer Model #15970 Colorimeter, Photometer, Spectrophotometer for clinical use FDA

MHRA

MHRA

MHRA

MHRAMHRA

MHRA

FDA

FDA

FDA

FDA

FDA

FDA

Johnson & Johnson Medical (HK)




















SN090423 Teleflex Medical (Arrow) 30, 40 and 50 cc Intra-Aortic Ballloon Z-1210-2009 to Z-1222-2009 Class I 2009/04/16

SN090424 Z-0998-2009 to Z-0999-2009 Class II 2009/04/16

SN090425 Biomet Offset Tibial Tray Adaptor, 5.0 MM, Sterile, REF 141491 Z-1061-2009 Class II 2009/04/16

SN090426 Abbott CELL-Dyn Ruby Hematology Analyzer (List no 08H67-01) Z-1064-2009 Class II 2009/04/16

SN090427 Z-1065-2009 to Z-1068-2009 Class II 2009/04/16

SN090428 Z-1071-2009 to Z-1072-2009 Class II 2009/04/16

SN090429 GE Healthcare Infinia Hawkeye and Hawkeye 4 Z-1094-2009 to Z-1095-2009 Class II 2009/04/16

SN090430 GE Healthcare Infinia, Hawkeye for Infinia and Infinia Hawkeye 4 Z-1119-2009 to Z-1121-2009 Class II 2009/04/16

SN090431 Cardinal Health ReadyMed Elastomeric Ambulatory Pump Z-1170-2009 Class II 2009/04/16

SN090432 Z-1171-2009 Class II 2009/04/16

SN090433 Bard Dual Port Wizard Low Profile Replacement Gastrostomy Device Z-1096-2009 to Z-1117-2009 Class II 2009/04/16

SN090434 Integra Bilayer Matrix Wound Dressing, 8" x 10" (20cm x 25cm); Non-pyrogenic Z-1174-2009 Class II 2009/04/16

SN090435 diaDexus PLAC Test Reagent Kit (Catalog no 90110) Z-1204-2009 Class II 2009/04/16

SN090436 Teleflex Medical Pilling Coronary Scissors (Cataolg no 352164-352169 & 352178) Z-1175-2009 to Z-1181-2009 Class II 2009/04/16

SN090437 Siemens HM Reaction Vessels (RXV1A) 2008/012/002/061/010 FSCA 2009/04/16

SN090438 i-sens Caresens II BGM Others N.A. N.A. 2009/04/17

SN090439 Sybron Pitt Easy Implant 2008/012/002/061/010 FSCA 2009/04/20

SN090440 James Leckey EAS Floor Mat 2009/003/016/301/002 FSCA 2009/04/22

SN090441 Homecraft Rolyan Frimley folding stool model AA1550 2009/001/030/401/010 FSCA 2009/04/22

SN090442 Stryker Modular Replacement System (MRS) Cemented Stems Z-1251-2009 Class II 2009/04/23

SN090443 Stryker AxSOS T8 Screwdriver and AxSOS Torque Limiting Screwdriver Z-1062-2009 to Z-1063-2009 Class II 2009/04/23

SN090444 Stryker Trio Small Offset Connector Non Sterile (Catalog no 48902015) Z-0986-2009 Class II 2009/04/23

SN090445 GE Healthcare Infinia, Infinia Hawkeye and Infinia Hawkeye 4 Z-1001-2009 to Z-1003-2009 Class II 2009/04/23

SN090446 Z-1046-2009 to Z-1051-2009 Class II 2009/04/23

SN090447 Maquet ALM Prismatic Surgical Light 9551 DF and ALM Prismatic Surgical Light 54004 SF Z-1153-2009 to Z-1154-2009 Class II 2009/04/23

SN090448 Z-1250-2009 Class II 2009/04/23

FDA

Cardinal Health (Viasys Healthcare) Sonora Transcranial Doppler (TCD) System (Model Sonara, Part no 982A0469 and 982A0470) FDA

FDA

FDA

Roche/Hitachi Modular Analytics System (Modular D2400 Module; P800 Module; D Module; D Module) FDA

Boston Scientific Convoy Advanced Delivery Sheath Kit and Soft Tip Sheath Multipurpose Introducing Sheath Kit FDA

FDA

FDA

FDA

Medtronic Physio Control Internal Sterilizable Paddles and Handles without discharge control for use with LIFEPAK 9 and LIFEPAK 9P defibrillators/monitors FDA

FDA

FDA

FDA

FDA

MHRA

MHRA

MHRA

MHRA

FDAFDAFDA

FDA

Abbott AxSYM HBsAg Reagent Pack, AxSYM CMV IgG Regent Pack, AxSYM CORE 2.0 Reagent Pack, AxSYM Folate Reagent Pack, AxSYM Myoglobin Reagent Pack and AxSYM Troponin-I ADV Reagent Pack

FDA

FDA

Cardiovascular System DiamondBack 360, CSI ViperWire Orbital Atherectomy Guide Wire (REF: GW14335FRM) FDA



























SN090449 2009/003/030/061/008 FSCA 2009/04/23

SN090450 Philips HeartStart XL M4735A Defibrillator/Monitor N.A. Firm Initiated Field Action 2009/04/23

SN090451 Philips HeartStart MRx/MRxE M3535A/M3536A/M3536J Defibrillator/Monitor N.A. Firm Initiated Field Action 2009/04/23

SN090452 ThermoFisher BO0332D Ringers Solution 1/4 Strength lot 1067747 2009/001/029/601/001 FSCA 2009/04/29

SN090453 Stryker Restoration Modular Cone Bodies 2009/003/025/291/008 FSCA 2009/04/29

SN090454 Abbott Hematology Reagent Syringe (List no 08H49-02) Z-1069-2009 Class II 2009/04/30

SN090455 Berchtold Operon Electrical Operating Room Table Z-1123-2009 Class II 2009/04/30

SN090456 Pointe Scientific Liquid Auto HDL CHolesterol Reagent Set Z-1200-2009 to Z-1201-2009 Class II 2009/04/30

SN090457 DiaDexus PLAC Test Calibrator Kit (Catalog No. 90108 and 10-0108) Z-1205-2009 Class II 2009/04/30

St.Jude Medical EP-4 Stimulator 2 and 4 channels and EP WorkMate containing the EP4 stimulator MHRA

Philips Health Care (Great China)


MHRA

MHRA

FDA

FDA

FDA

FDA









Local Agent

N.A. N.A.




Leica Microsystems Ltd 2564 6699

N.A. N.A.


3M 2806 6349


N.A. N.A.

N.A. N.A.


N.A. N.A.

N.A. N.A.



N.A. N.A.

N.A. N.A.

TRUMPF China (Hong Kong) Ltd. 2880 9808

N.A. N.A.


N.A. N.A.



N.A. N.A.


N.A. N.A.








N.A. N.A.

N.A. N.A.

N.A. N.A.

N.A. N.A.


BioScan Ltd 3589 6670

N.A. N.A.

N.A. N.A.

N.A. N.A.






Maquet Hong Kong LTD. 2393 9511

N.A. N.A.


N.A. N.A.



N.A. N.A.



N.A. N.A.

N.A. N.A.

N.A. N.A.


Monthly Summary of Medical Device Safety Alerts - March 2009*Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada


SN090301 Draeger Medical Oxylog 3000 Ventilator (2M86955) 44596 Type II 2009/03/03

SN090302 Oxoid Limited Oxoid Fraser Broth Base (CM0895B) 45182 Type II 2009/03/03

SN090303 Biomet Modular Microplasty Cup Inserter 43310 Type II 2009/03/03

SN090304 Miltex Stainless Steel Surgical Blades 46242 Type II 2009/03/03

SN090305 Ohio Willow Wood Duralite Pyramid Receiver Proximal Adapter (FND-136102) 44165 Type II 2009/03/03

SN090306 GE Diamond Mammography X-Ray Equipment (81000) 44731 Type II 2009/03/03

SN090307 GE Datrex-Ohmeda Network and Icentral (M1113714, M1113715) 44822 Type II 2009/03/03

SN090308 44184 Type II 2009/03/03

SN090309 45981 Type II 2009/03/03

SN090310 GE OEC Mobile Elite C-Arms Gen. Platform, OEC Mobile Elite - Arms Cooling 44335 Type II 2009/03/03

SN090311 Siemens Immulite 2000 system-analyzer class III & II, Immulite 2000 - Instrument Class IV 46193 Type II 2009/03/03

SN090312 46137 Type II 2009/03/03

SN090313 Draeger Evita 4, Evita 2 Dura, Evita XL 42978 Type II 2009/03/03

SN090314 DORC international MembraneBlue© 0.5ml syringe MDA/2009/017 MDA 2009/03/04

SN090315 Philips Diagnostic Ultrasound System (Model HD3 and HDI4000) Z-0522-2009 to Z-0523-2009 Class II 2009/03/05

SN090316 Medtronic Surgical Membrane Oxygenator Z-0975-2009 Class II 2009/03/05

SN090317 Z-0972-2009 Class II 2009/03/05

SN090318 Z-0951-2009 Class II 2009/03/05

SN090319 Abbott Architect / Aeroset Clinical Chemistry Iron/Magnesium Calibrator (List No. 1E69-03) Z-0950-2009 Class II 2009/03/05

SN090320 Terumo Advanced Perfusion System 1 Z-0909-2009 to Z-0910-2009 Class II 2009/03/05

SN090321 Z-0973-2009 Class II 2009/03/05

SN090322 Z-0980-2009 Class II 2009/03/05

SN090323 Welch Allyn AED 10 and former MRL Jumpstart Automated External Defibrillators Welch Allyn N.A. Firm Initiated Field Action 2009/03/05

SN090324 Medtronic Physio-Control Lifepak 20 defibrillator/monitor - Keypad Medtronic International Ltd N.A. Firm Initiated Field Action 2009/03/10


Health Canada

Health CanadaHealth Canada

Health Canada

Health Canada

Health Canada

Health Canada

Stryker (Howmedica Osteonics) Securefit Hip Stem - 132 degree, Securefit Hip Stem - 127 degree, Solar Shoulder - Humeral Component, Ostenoics Omnifit Hip Stem Health Canada

Stryker (Howmedica Osteonics) Osteonics Omnifit M-HA Hip Stem, Accolade TMZF Press Fit Stem 132 Degree, Accolade TMZF Press Fit Stem 127 Degree Health Canada

Health Canada

Health Canada

Philips Gemini GXL 6/10/16 Slice PET/CT, Gemini TF 16 PET?CT system, Gemini TF 64 PET/CT System Health Canada

Health CanadaMHRA

FDAFDA

Stryker Endoscopy brand 3.5mm Super 90-S SERFAS Enegry Suction Probe (Model no 279-351-200) FDA

Abbott ACCELERATOR APS Centrifuge Module (Hettich Robotic centrifuge) (List no: 07L02-01) FDA

FDA

FDAExcelsior Medical Sterile Field Saline Flush (Product codes: E0100 20, 100 92-240 and 100 92-30) FDA

Cook Medical Universa Soft Ureteral Stent and Positioner with Hydrophillic Coating (REF USH-526-R, GPN REF G49966) FDA

http://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/_list/rec-ret_md-im_date_jan-march_2009-eng.php























SN090325 Sunrise Medical Quickie Groove battery powered wheelchairs MDA/2009/018 MDA 2009/03/10

SN090326 CMS Software 4.3.1 through 4.40.00 2009/002/015/601/001 FSCA 2009/03/10

SN090327 Cardiac Science Powerheart and First Save AED Z-0916-2009 to Z-0922-2009 Class II 2009/03/12

SN090328 InteliFUSE Drill Bit (REF: DB.150.JL and DB.200.JL) Z-1032-2009 to Z-1033-2009 Class II 2009/03/12

SN090329 Z-0955-2009 Class II 2009/03/12

SN090330 Zimmer Orthosoft Navitrack, OS Unicodylar Knee 1.0- Universal Z-0985-2009 Class II 2009/03/12

SN090331 Z-1013-2009 Class II 2009/03/12

SN090332 Medtronic VARI-STIM III Nerve Locator/Stimulator Z-0947-2009 Class II 2009/03/12

SN090333 Z-0944-2009 Class II 2009/03/12

SN090334 GE Healthcare Innova Biplane 3131 2008/006/013/601/413 FSCA 2009/03/13

SN090335 Zimmer NCB cancellous screw 4.5mmx 48mm Self tapping 2009/002/020/291/022 FSCA 2009/03/13

SN090336 VYGON PROTECT-A-SPIRAL – 300CM 2009/002/026/601/003 FSCA 2009/03/13

SN090337 IPSOGEN JAK2 MutaScreen Kit 2009/002/010/291/016 FSCA 2009/03/16

SN090338 Philips Multi Diagnost Eleva FD - Leaking X-Ray Tube Grid 2008/011/020/061/028 FSCA 2009/03/16

SN090339 Boston Scientific Wiseguide Guide Catheter N.A. Firm Initiated Field Action 2009/03/16

SN090340 BD Falcon 100 x 20 mm Tissue Culture - Treated Dish (BD Cat no 353003) BD N.A. Firm Initiated Field Action 2009/03/17

SN090341 Unihoist University Bath Hoist and University Bath Hoist Transporter 2008/011/006/301/002 FSCA 2009/03/18

SN090342 Stryker Triathlon Primary 46302 Type II 2009/03/18

SN090343 Stryker Triathlon Primary Cemented Baseplate (5520-B-400) 46208 Type II 2009/03/18

SN090344 Smith & Nephew Tandem Unipolar 46 mm Femoral Heads (126646) 46556 Type II 2009/03/18

SN090345 Zimmer Minimally Invasive Solutions Technology Offset RASP Handles 46270 Type II 2009/03/18

SN090346 Technidata Logiciel TDHIsto/CytoSoftware 44729 Type II 2009/03/18

SN090347 Computerized Medical Systems Focal Software CD 46521 Type II 2009/03/18

SN090348 Bard Fantrac "Paul" Gastric Access Port Kit (Model 5729) 45860 Type II 2009/03/18

SN090349 Genzyme Diagnostics Enzymatic Creatinine Assay 46641 Type II 2009/03/18

SN090350 Nipro Blood Tubing Set for Hemodialysis (A230TR/V810TR) 45627 Type II 2009/03/18

SN090351 Armstrong Medical Amsorb Plus Prefilled Bubble-Can Universal WTOV 46652 Type II 2009/03/18

SN090352 46636 Type II 2009/03/18

SN090353 46404 Type II 2009/03/18

MHRA

MHRAFDAFDA

Johnson and Johnson (Animas) Meter Remote for OneTouch Ping Glucose Management System FDA

FDA

Stryker Triathlon X3 Posterior Stabilized Tibial Insert Use with Triathlon PS Femoral Components (Catalog no 5532-G-713 & 5532-G-813) FDA

FDA

Hospira Symbiq One-Channel (List no 16026-04) and Two-Channel (list no 16027-04) Infusion System FDA

MHRAMHRAMHRAMHRAMHRA


MHRA

Health Canada

Health Canada

Health Canada

Health Canada

Health Canada

Health Canada


Health Canada

Cardinal Health Sterile Pacemaker and Defibrillator Pack (SAN30PAXXX), Sterile Shoulder Pack (SOP30ASXXX) Health Canada

PDSII Monofilament suture, Coated Vicryl Absorable Suture, PDS II Suture, Monocryl Plus Antibacterial Suture, Coated Vicryl Plus Antibacterial Ethicon Suture Health Canada





























SN090354 45280 Type II 2009/03/18

SN090355 Biomet Sports Medicine 9-10mm Ezloc Femoral Fixation Device (904781) 44280 Type II 2009/03/18

SN090356 GE Innova 3100/3100IQ and Innova 4100 /4100IQ Z-1092-2009 to Z-1093-2009 Class II 2009/03/19

SN090357 Medtronic PROSTIVA RE Model 8929 Hand Piece Z-1060-2009 Class II 2009/03/19

SN090358 Medtronic TSRH 3DX Implant Set and TSRH Spinal System Z-1014-2009 to Z-1017-2009 Class II 2009/03/19

SN090359 Z-1021-2009 to Z-1030-2009 Class II 2009/03/19

SN090360 Zimmer Most Hinged Tibia Baseplate Spacer (REF 5020-06-001) Z-0996-2009 Class II 2009/03/19

SN090361 Integra Mosail Putty and Dermal Regeneration Template-TS Z-1034-2009 to Z-1035-2009 Class II 2009/03/19

SN090362 Pointe Scientific Glucose Oxidase Reagent Z-1091-2009 Class II 2009/03/19

SN090363 Remel Wellcolex colour salmonella Kits, R30858301 (50 tests)/R30858302 2009/003/006/051/003 FSCA 2009/03/19

SN090364 ConMed Fortis II ConMed Limited N.A. Firm Initiated Field Action 2009/03/19

SN090365 Philips GXR RF Systems with DI (EasyDiagnost Eleva) N.A. Firm Initiated Field Action 2009/03/19

SN090366 CORONA MEDICAL Patient Beds (Side Rails) CORONA MEDICAL N.A. Firm Initiated Field Action 2009/03/20

SN090367 GE AS/3 Anaesthesia Delivery Unit, S/5 Anaesthesia Delivery Unit, and ADU Carestation 2009/002/013/601/003 FSCA 2009/03/23

SN090368 Medtronic Sprint Fidelis Lead Medtronic International Ltd N.A. Firm Initiated Field Action 2009/03/23

SN090369 Maquet Servo ventilators 300 and 300A MDA/2009/020 MDA 2009/03/25

SN090370 2009/002/020/291/012 FSCA 2009/03/25

SN090371 GE Datex-Ohmeda Aisys and GE Datex-Ohmeda Avance Anesthesia Machines 2009/002/017/601/001 FSCA 2009/03/25

SN090372 Draeger Medical Patient monitor bracket 2009/003/010/051/014 FSCA 2009/03/25

SN090373 Aidapt VR231 Lenham adjustable height commode 2009/001/007/401/004 FSCA 2009/03/25

SN090374 Abbott Xience V Everilimus Eluting Coronary Stent System, 2.5 x 28mm Abbott Laboratories LTD. N.A. Firm Initiated Field Action 2009/03/25

SN090375 BD PrepStain System (Model no.: 799-14000-00) Z-1090-2009 Class II 2009/03/26

SN090376 Z-1070-2009 Class II 2009/03/26

SN090377 Rochester Medical Magic3 (Intermittent Catheter) and HydroSil (Intermittent Catheter) Z-1074-2009 to Z-1087-2009 Class II 2009/03/26

SN090378 Biosite Triage Drugs of Abuse Panel (Model No 95000) Z-1088-2009 Class II 2009/03/26

Baxter Healthcare Colleague Volumetric Infusion Pump, Colleague 3 Volumetric Infusion Pump, Colleague Guardian Enhanced CXE Pump, Colleague Guardian Enhanced 3CXE Pump, French Colleague CXE Volumetric Pump, French Colleague 3 CXE Volumetric Pump

Health Canada

Health Canada

FDAFDAFDA

Stryker Cordless Driver 3 Handpiece, Rotary Handpiece, Reciprocating Saw, Sternum Saw, Sagittal Saw and Precision Oscillating Tip Saw FDA

FDA

FDA

FDA

MHRA


MHRA

MHRA

Smiths Medical Near empty flag kits product code 0131-0122 and halfnut, leadscrew and flag kits product code 0131-0236 for 3000 series graseby syringe pumps MHRA

MHRA

MHRA

MHRA

FDA

LifeScan (Johnson and Johnson) OneTouch SureStep Test Strips (Part no.: 020-052-01 and 010-359-04) FDA

FDA

FDA






















SN090379 BD Insyte Autoguard Shielded IV Catheter BD N.A. Firm Initiated Field Action 2009/03/26

SN090380 Boston Scientific Flexima and Percuflex Drainage Catheter Family (Pigtail Style) N.A. Firm Initiated Field Action 2009/03/27

SN090381 GE Mobile Care Server L-WEB05 and iCentral L-NET05 2008/009/018/601/004 FSCA 2009/03/27

SN090382 N.A. Class I 2009/03/30

SN090383 Novo Nordisk NovofineR Needles 31G, 0.25 mm x 6 mm lot number 08J02S MDA/2009/021 MDA 2009/03/30

SN090384 AstraZeneca Nebuchamber Astrazeneca Hong Kong Ltd N.A. Firm Initiated Field Action 2009/03/30

SN090385 ZOLL AED Plus Defibrillator N.A. Urgent Safety Information 2009/03/31


MHRAMedtronic Innervision Snap Shunt Ventricular Catheter, BioGlide and Snap Shunt Ventricular Catheter, BioGlide FDA

MHRA

Health Canada




http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2009/zoll_def_hpc-cps-eng.php


Local Agent

N.A. N.A.

South East Chemicals & Instruments Ltd. N.A.

N.A. N.A.

N.A. N.A.

N.A. N.A.








N.A. N.A.

N.A. N.A.







N.A. N.A.

N.A. N.A.

N.A. N.A.




N.A. N.A.

N.A. N.A.

N.A. N.A.

N.A. N.A.





Hospira Limited 2898 2886


Zimmer PTE Ltd. (Hong Kong branch) 2992 0968N.A. N.A.

N.A. N.A.



BD 2575 8668

N.A. N.A.



Smith & Nephew LTD N.A.


N.A. N.A.

N.A. N.A.

N.A. N.A.

N.A. N.A.

N.A. N.A.

N.A. N.A.




Baxter Healthcare Ltd 2807 8516

N.A. N.A.






N.A. N.A.

N.A. N.A.


ConMed Limited N.A.


N.A. N.A.




GOODMAN MEDICAL SUPPLIES LTD 2332 4455


2877-3077

N.A. N.A.


BD 2575 8668


N.A. N.A.

Biosite Incorporated 2855 6883

Draeger Medical Hong Kong Ltd.


BD 2575 8668




N.A. N.A.

Astrazeneca Hong Kong Ltd 2491 5206

Suburfarm Investment & Trading Co. 2780 9421


Monthly Summary of Medical Device Safety Alerts - February 2009*Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada


SN090201 Medtronic LIFEPAK 12 and LIFEPAK 20/20e Defibrillator / Monitor Medtronic International Ltd N.A. Firm Initiated Field Action 2009/02/02

SN090202 Beckman Coulter UniCel DxC 880i Synchron Access Clinical Systems 2009/001/023/601/001 FSCA 2009/02/02

SN090203 Xcelens IDEA 613XC 2009/001/026/291/003 FSCA 2009/02/02

SN090204 Stryker GAMMA3 Trochanteric Nail 180 Operative Technique 2009/001/008/291/002 FSCA 2009/02/02

SN090205 Activate Patron Bohemia TOM Cross Country Chassis 2008/009/016/401/009 FSCA 2009/02/02

SN090206 2008/011/027/061/008 FSCA 2009/02/02

SN090207 ThermoFisher BO0471D, 0.1% Peptone Water + 0.85% Salt 2009/001/026/601/005 FSCA 2009/02/02

SN090208 ThermoFisher EB0348D, Maximum Recovery Diluent 2009/001/026/601/006 FSCA 2009/02/02

SN090209 Smith & Nephew BHR BRIDGING CUP, 66MM PRODUCT CODE 74120366 2009/001/028/601/002 FSCA 2009/02/02

SN090210 Johnson and Johnson DePuy Vac-Mix plus pre-packed with Endurance Bone Cement N.A. Firm Initiated Field Action 2009/02/03

SN090211 BD FACS Sample Prep Assistant (SPA or SPA II) BD N.A. Firm Initiated Field Action 2009/02/03

SN090212 GE Centricity PACS RA1000 Workstation Z-0836-2009 Class II 2009/02/05

SN090213 iCAD 3TP TheraMap Software and 3TP PrecisionPoint Software Z-0653-2009 to Z-0654-2009 Class II 2009/02/05

SN090214 Virtus Expressaire, Disposable Tourniquet Cuff (Cuff type A70107010, A70107011) Z-0907-2009 to Z-0908-2009 Class II 2009/02/05

SN090215 Fresenius Medical CombiSet True Flow Series, Hemodialysis Blood Tubing Z-0859-2009 to Z-0860-2009 Class II 2009/02/05

SN090216 Z-0854-2009 Class II 2009/02/05

SN090217 Coloplast EasiCath intermittent urinary catheters MDA/2009/007 MDA 2009/02/05

SN090218 Teleflex Medical Ligating clips MDA/2009/008 MDA 2009/02/09

SN090219 Johnson and Johnson (DePuy) DNP Anatomic Fracture Repair System 2009/001/026/291/007 FSCA 2009/02/09

SN090220 Smith & Nephew Compass PIP Hinge Smiths & Nephew Ltd N.A. Firm Initiated Field Action 2009/02/09

SN090221 Doddmed Metrax Primedic HeartSave AED, HeartSave AED-M 2008/011/010/061/024 FSCA 2009/02/10

SN090222 2009/001/030/291/008 FSCA 2009/02/10

SN090223 Zimmer Coonrad/Morrey Total Elbow System Surgical Technique 2009/002/005/291/017 FSCA 2009/02/10

SN090224 Johnson and Johnson STERRAD 50 Sterilization System 2009/001/030/291/010 FSCA 2009/02/10

SN090225 ThermoFisher BO0348N Maximum Recovery Diluent 2009/001/029/601/002 FSCA 2009/02/10

SN090226 Medtronic LIFEPAK 20 Defibrillator / Monitor Medtronic International Ltd N.A. Firm Initiated Field Action 2009/02/11

SN090227 Medtronic O-Arm Intraoperative Imaging System (Catalog no.: BI-700-0027) Z-0624-2009 Class II 2009/02/12

SN090228 Terumo Advanced Perfusion System 1 Z-0670-2009 to Z-0674-2009 Class II 2009/02/12


MHRAMHRAMHRAMHRA

James Leckey Advanced, Contoured Advanced, Squiggles Saddle and Squiggles Early Sitting Seating Sytems MHRA

MHRAMHRA

MHRA


FDAFDA

FDA

FDA

Integra Ruggles Surgical Instrument ACF Distraction Screws Sterile, Rx only (Catalog no.: R6357A, R6397A) FDA

MHRAMHRAMHRA

MHRABD Vacutainer Plastic Sodium Heparin Blood Collection Tube with Green BD Hemogard Closure, 13 x 75 mm, 4 ml. MHRA

MHRAMHRAMHRA

FDA

FDA

























SN090229 Z-0884-2009 Class II 2009/02/12

SN090230 Stryker various modular components Z-0888-2009 to Z-0902-2009 Class II 2009/02/12

SN090231 Z-0864-2009 to Z-0867-2009 Class II 2009/02/12

SN090232 Activate Hi-Lo Powered Wheelchair 2008/010/001/061/003 FSCA 2009/02/12

SN090233 Invacare Flamingo Hoist 2009/001/022/301/001 FSCA 2009/02/12

SN090234 Mecall UNISTAT L floor stand 2008/012/030/401/007 FSCA 2009/02/12SN090235 Vitech Scientific Starrsed Compact Interrliner 2008/007/023/401/007 FSCA 2009/02/12

SN090236 BrainLAB Radiolucent Spine Reference Clamp BrainLAB Ltd N.A. Firm Initiated Field Action 2009/02/12

SN090237 Millipore Corporation Bioscience Simulfluor Flu A/B Immunofluor Assay (Model:3121, 5250) 45681 Type II 2009/02/13

SN090238 Baxter Healthcare Rear Case Assembly For Auto Syringe (Model: 1M8560R) 43803 Type II 2009/02/13

SN090239 Problem Solving Concepts Prosolv Cardiovascular Image and Information Management 46106 Type II 2009/02/13

SN090240 Encore Medical Modular Femoral Neck 44847 Type II 2009/02/13

SN090241 Tremblay Harrison Minute Lab PSA Semi-Quantitative Test (Model: PSD-A1, PSS-A1) 46147 Type II 2009/02/13

SN090242 Imaging Sciences International Gendex GXCB-500 Cone Beam 3-D Imaging (Model: 45997) 45997 Type II 2009/02/13

SN090243 Immucor Galileo Echo Blood Bank Analyzer 45821 Type II 2009/02/13

SN090244 Medtronic Durepair Dura Regeneration Matrix 45672 Type II 2009/02/13

SN090245 Bio-Rad Laboratories Bioplex 2200 Detector Calibration Packs 45218 Type II 2009/02/13

SN090246 45219 Type II 2009/02/13

SN090247 ThermoFisher BO0351G, Tryptone soya broth, lot number 1066679 2009/001/026/601/003 FSCA 2009/02/13

SN090248 TRB Chemedica Visiol Syringe 20mg/ml 2008/012/023/291/008 FSCA 2009/02/13

SN090249 BD Insyte Autogard I.V Catheter 2009/001/030/291/009 FSCA 2009/02/16

SN090250 Elekta Precise Treatment Table 2009/002/011/291/007 FSCA 2009/02/16

SN090251 BioMerieux Bacteriology culture medium. Chocolate agar + PolyViteX VCAT3 agar MDA/2009/011 MDA 2009/02/17

SN090252 Mast Laboratories V Factor Catridges 2009/002/009/601/001 FSCA 2009/02/18

SN090253 STAAR Surgical Aquaflow collagen glaucoma drainage device 2008/011/024/291/008 FSCA 2009/02/18

SN090254 Spacelabs Healthcare Blease 700/900 Ventilator 2009/002/005/291/006 FSCA 2009/02/18

SN090255 Sunrise Medical DeVilbiss Model 7310PR-D VacuAide Compact Suction Unit Z-0863-2009 Class II 2009/02/19

SN090256 Z-0923-2009 to Z-0925-2009 Class II 2009/02/19

SN090257 Stryker PainPump 2 Blockaid (REF 575-100) Z-0926-2009 Class II 2009/02/19

Stryker Restoration Modular Conical Distal Stem, Titanium Alloy (Catalog no 6276-7-017 (17mm); 6276-7-014 (14mm)) FDA

FDA

Biomet MicrofixationLactosorb System (REF: 915-1006); Lactosorb, Office Fixation Kit (REF: 915-1000); MF Set (REF: 01-6871); Office System (REF: 01-6851) FDA

MHRAMHRAMHRAMHRA

Health Canada

Health Canada

Health Canada

Health Canada

Health Canada

Health Canada


Bio-Rad Laboratories Liquicheck Cardiac Markers Control LT - Trilevel (145), Level 1(146), Level 2 (147), Level 3 (148), Trilevel Minipak (145x) Health Canada

MHRAMHRAMHRAMHRA

MHRA

MHRAMHRA

MHRA

FDA

Stryker PainPump (Prodcut no.: 0500-166-025, 0500-166-050, 0500-200-000; REF: 500-166-25; 500-166-50, 500-200 FDA

FDA






























SN090258 Stryker AVS AL Spacer Trial Inserter; Non Sterile (Catalog no 48329800) Z-0936-2009 Class II 2009/02/19

SN090259 GE Centricity PACS RA1000 Workstation (for diagnostic image analysis) Z-0928-2009 Class II 2009/02/19

SN090260 Z-0949-2009 Class II 2009/02/19

SN090261 AGFA IMPAX Cardiovascular Polling Procedure version 1.00.09 Z-0945-2009 Class II 2009/02/19

SN090262 Posey Connecting Straps and Belts/Locking Cuffs Z-0934-2009 Class II 2009/02/19

SN090263 Z-0956-2009 to Z-0959-2009 Class II 2009/02/19

SN090264 Synthes Nfix II System, N-Hance System, TI N-Hance Rod, Nflex Stabilization System Z-0963-2009 to Z-0968-2009 Class II 2009/02/19

SN090265 Teleflex Medical CC IAB Catheters/Volume Connectors 2009/002/010/291/018 FSCA 2009/02/20

SN090266 Maquet Heartstring II Proximal Seal System 2009/002/013/051/002 FSCA 2009/02/23

SN090267 Blatchford Endolite 30mm Pyramid Adapt 2008/009/008/401/012 FSCA 2009/02/23

SN090268 Siemens Sireskop SX and AXIOM Sireskop SD 2009/002/013/051/003 FSCA 2009/02/23

SN090269 Tyco Shiley 3.0 Cuffless Paediatric Tracheostomy 2009/001/023/291/001 FSCA 2009/02/24

SN090270 MDA/2009/016 MDA 2009/02/25

SN090271 Edwards Lifesciences Swan-Ganz Thermodilution Catheters 2009/002/018/291/008 FSCA 2009/02/25

SN090272 Abbott RealTime HIV-1 Assay 2009/002/019/291/015 FSCA 2009/02/25

SN090273 2009/002/018/291/007 FSCA 2009/02/25

SN090274 Z-0861-2009 Class II 2009/02/26

SN090275 Boston Scientific Atlantis PV Peripheral Imaging Catheter (Model no H749364560) Z-0837-2009 Class II 2009/02/26

SN090276 Philips M8000-64100 Table Mount Z-0817-2009 Class II 2009/02/26

SN090277 Z-0646-2009 Class II 2009/02/26

SN090278 Z-0540-2009 to Z-0541-2009 Class II 2009/02/26

SN090279 Zoll Monitor portion of the LifeVest device (Model no. WCD3000 and WCD3100) Z-0883-2009 Class II 2009/02/26

SN090280 Ossur 3" Titanium Skull Pin, 3" Ceramic Tip Pin,2 1/4" Ceramic Tip Pin Z-0594-2009 to Z-0596-2009 Class II 2009/02/26

SN090281 Z-0915-2009 Class II 2009/02/26

SN090282 Baxter System 1000 and Arena Haemodialysis instruments 2009/002/010/291/017 FSCA 2009/02/27

SN090283 Edwards Lifesciences Fem-FlexII Paediatric Catheter 2009/002/018/291/010 FSCA 2009/02/27

SN090284 GE Giraffe Warmer & Panda iRes 2009/001/021/601/001 FSCA 2009/02/27

FDAFDA

Siemens Artiste MV Digital Linear Accelerator System equipped with 160 MCL Accessory Holder FDA

FDAFDA

Advanced Bionics HR90K Platinum Series Headpiece; Platinum Series Headpiece ; S-Series Long Range Headpiece, S- Series Short Range Headpiece FDA

FDA


Johnson and Johnson (DePuy) Total knee replacement implant femoral components – PFC SIGMA MHRA

MHRAMHRA

ConMed Endoscopic Disposable Polypectomy Snares and Gastrostomy Feeding Systems - EnTake PEG MHRA

Varian Medical Systems Eclipse treatment planning system (Model no. H48, versions 6.5/7.x and Inspiration 8.0) FDA

FDA

FDA

Siemens Drive Belt for Radiation Therapy Simulation Systems SIMVIEW 3000 and SIMVIEW NT with CT option or IDI FDA

Siemens MicroScan Synergies Plus Dried Overnight Gram Negative MIC/Combo Panels and MicroScan Synergies Plus Negative Panels FDA

FDA

FDA

Mako Surgical Femoral Array (Model no 0150ARR00001) and Tibial Array (Model no 0150ARR00002) FDA

MHRAMHRAMHRA





























SN090285 Bio-Rad Laboratories Variant II Sytem with CDM 3.5 software, 3.6T System 46347 Type I 2009/02/27

SN090286 Boston Scientific Precision Spinal Cord stimulation system 44523 Type II 2009/02/27

SN090287 Bard Access Ponsky Non-Ballon Gastrostomy tube 42263 Type II 2009/02/27

SN090288 Fresenius Medical Patient On Line 41821 Type II 2009/02/27

Health Canada







Local Agent



N.A. N.A.


N.A. N.A.

N.A. N.A.

N.A. N.A.

N.A. N.A.

Smith & Nephew LTD N.A.


BD 886-2722-5660


N.A. N.A.

N.A. N.A.

Fresenius Medical Care Asia Pacific Ltd. 2802 2900

N.A. N.A.

N.A. N.A.

N.A. N.A.

N.A. N.A.

Smiths & Nephew Ltd 9651 5523

N.A. N.A.

BD 886-2722-5660

Zimmer PTE Ltd. (Hong Kong branch) 2992 0968Johnson & Johnson Medical (HK) 2738 6027

N.A. N.A.








N.A. N.A.

N.A. N.A.

N.A. N.A.

N.A. N.A.N.A. N.A.

BrainLAB Ltd 2417 1881

Millipore Hong Kong 2803 9249


N.A. N.A.

N.A. N.A.

N.A. N.A.

N.A. N.A.

Uninet Technology LTD 2838 8423




N.A. N.A.

N.A. N.A.

BD 886-2722-5660

N.A. N.A.

Biomerieux China Ltd. (HK office) 2356 7033

N.A. N.A.

N.A. N.A.

N.A. N.A.

N.A. N.A.







AGFA Hong Kong Limited 2555 9421

N.A. N.A.

N.A. N.A.


N.A. N.A.



Tyco Healthcare (HKSAR) LTD 3157 7220


N.A. N.A.


N.A. N.A.






N.A. N.A.

N.A. N.A.

N.A. N.A.


N.A. N.A.





N.A. N.A.



Monthly Summary of Medical Device Safety Alerts - January 2009*Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada


SN090101 Terumo Advanced Perfusion System 1 (Model 801763 and 801764) Z-0445-2009 to Z-0446-2009 Class II 2009/01/02

SN090102 Z-0476-2009 Class II 2009/01/02

SN090103 FHC microTargeting Platform DBS Measuring Fixture (Cataog # 66-FA-SF) Z-0486-2009 Class II 2009/01/02

SN090104 Z-0593-2009 Class II 2009/01/02

SN090105 SiemensIMMULITE/IMMULITE 1000 Progesterone (LKPG 1,5) Z-0524-2009 Class II 2009/01/02SN090106 Enterix Insure Quik Fit Developer Kit (Product no 30025 and 50025) Z-0480-2009 Class II 2009/01/02SN090107 Qualigen FastPack Total PSA Immunoassay (Catalog# 25000001) Z-0500-2009 Class II 2009/01/02

SN090108 Stryker Stair Chairs Stair-PRO 6251, Stair-PRO 6252, Evacuation Chair Model 6253 2008/011/028/061/020 FSCA 2009/01/07

SN090109 Johnson and Johnson ENDOPATH® Electrosurgery Probe Plus II 2008/012/009/061/007 FSCA 2009/01/07SN090110 ArthroCare Saber 30 with Integrated Cable Wand 2008/012/009/061/003 FSCA 2009/01/08SN090111 EV3 Marathon Flow Directed Micro Catheter Catalog Number 105-5055 2008/012/009/061/015 FSCA 2009/01/08SN090112 GE Centricity Ultra Laboratory System Software Z-0472-2009 Class II 2009/01/08SN090113 Siemens KinetDx 4.2 Workplace and syngo Dynamics Workplace Z-0543-2009 to Z-0545-2009 Class II 2009/01/08SN090114 Alphatec Spine Novel PEEK VBR XS Z-0507-2009 to Z-0508-2009 Class II 2009/01/08SN090115 Cordis MassTRANSIT Infusion Catheter Kit, 605-731K & 605-780K Z-0604-2009 Class II 2009/01/08SN090116 Stryker Leibinger New Generation/Universal Mandibular System Z-0610-2009 Class II 2009/01/08SN090117 Sunrise Medical DeVilbiss Model 515A Oxygen Concentrator Z-0617-2009 Class II 2009/01/08

SN090118 CovaTec Flexi-Seal Fecal Management System Advanced Odor Control Kit. Rx only Z-0618-2008 Class II 2009/01/08

SN090119 Edwards Lifesciences EndoClamp aortic catheter Z-0644-2009 to Z-0645-2009 Class II 2009/01/08SN090120 Hyphen BioMed Biophen Heparin 6 (various lots) 2008/012/003/061/001 FSCA 2009/01/09SN090121 Siemens ADVIA Centaur HIV 1/O/2 Enhanced (EHIV) Assay 2008/012/023/051/001 FSCA 2009/01/09SN090122 Arcomedical Infusion Syramed SP6000 Syringe Pumps 2008/011/005/601/004 FSCA 2009/01/09

SN090123 Boston Scientific Safety and Standard Push PEG Kits N.A. Firm Initiated Field Action 2009/01/13

SN090124 Zimmer NexGen® Complete Knee Solution Provisional Articular Surface 2008/012/016/061/007 FSCA 2009/01/14SN090125 ThermoFisher BO0366G Brain heart infusion, lot number 1070312 2008/012/015/601/005 FSCA 2009/01/14

SN090126 GE OEC 9900 Elite ESP Fluoroscopic x-Ray System and GSP Fluoroscopic x-Ray System Z-0341-2009 to Z-0342-2009 Class II 2009/01/14

SN090127 Rockwell Medical SteriLyte Liquid Bicarbinate, Formula CL-02 and RL-01 Z-0439-2009 to Z-0440-2009 Class II 2009/01/14SN090128 Innovative Implant Sinu-Lift System (Model SLS-1) Z-0505-2009 Class II 2009/01/14SN090129 Biomet Compress Instrument Anchor Plug Holders Z-0517-2009 to Z-0521-2009 Class II 2009/01/14

SN090130 Hill-Rom Synergy Pulse, Synergy Dynamic, Synergy Air Squared and Pro 2000 Z-0600-2009 to Z-0603-2009 Class II 2009/01/14

SN090131 Roche Diagnostics ISE Internal Standard Gen 2 (Catalog no 04522320190) Z-0542-2009 Class II 2009/01/14

SN090132 GE Solar 8000M System Z-0285-2009 Class II 2009/01/14SN090133 Siemens CT syngo Dual Energy Viewer (Model 10094833) Z-0647-2009 Class II 2009/01/14SN090134 Hitachi CXR4 Computed Tomography Scanner Z-0608-2009 Class II 2009/01/14

SN090135 ACIST CVi Angiographic Injection System (Model: CVi Toshiba interface Cable) Z-0643-2009 Class II 2009/01/14

SN090136 Diamedix Measles IgG Enzyme Immunoassay Test Kit (DIAMEDIX) Z-0607-2009 Class II 2009/01/14

SN090137 Zimmer Natural-Knee II System Modular Cemented Tibial Baseplate (Ref 6420-01-230) Z-0871-2009 Class II 2009/01/14


FDACTS (Guidant Cardiac Surgery) VASOVIEW 4 Endoscopic Vessel Harvesting System with VASOVIEW Flexible Endoscopic Tools FDA

FDASmiths Medical Wallace Oocyte Recovery Needles, Oocyte Recovery sets (Product no. ONS1633LL-750 and ONS1733LL-750) FDA

FDAFDAFDA

MHRAMHRAMHRAMHRAFDAFDAFDAFDAFDAFDAFDAFDA

MHRAMHRAMHRA


MHRAMHRAFDAFDAFDAFDAFDA

FDAFDAFDAFDAFDAFDAFDA






































SN090138 Frontier Medical Repose Mattress and Cushion 2008/009/015/301/001 FSCA 2009/01/15

SN090139 Boston Scientific Stonetome Single-Use Stone Removal Device N.A. Firm Initiated Field Action 2009/01/15

SN090140 45354 Type II 2009/01/15

SN090141 43740 Type II 2009/01/15

SN090142 Toshiba Aquilion One (TSX-310A/2) 44879 Type II 2009/01/15SN090143 Invacare Careguard Mattress 45093 Type II 2009/01/15SN090144 Medtronic DLP Pericardial / Intracardiac Sump 45468 Type II 2009/01/15SN090145 Philips Easydiagnost Eleva 45433 Type II 2009/01/15SN090146 Convatec Flexi-Seal FMS Advanced Odor Control 45051 Type II 2009/01/15SN090147 KCI Kinair IV 45500 Type II 2009/01/15SN090148 Maquet Maquet Foot Paddle 44983 Type II 2009/01/15SN090149 Philips Multi Diagnostic Eleva-Flat Detector-IM 44908 Type II 2009/01/15SN090150 Stryker Patient Registration Mask (Box of 5) 45115 Type II 2009/01/15SN090151 Coloplast Philips Bougle 45314 Type II 2009/01/15SN090152 Roche Diagnostics Process System Manager 44820 Type II 2009/01/15SN090153 Smith & Nephew Reflection Hip PE Inlay (7174-0250) 45263 Type II 2009/01/15SN090154 Synthes (Canada) Synfix LR, Low Profile U-Joint Driver 45120 Type II 2009/01/15SN090155 KCI Therapulse ATP 44999 Type II 2009/01/15SN090156 Biomerieux Vitek 2 GN Card 44650 Type II 2009/01/15

SN090157 Abbott Voyager RX Coronary Dilation Catheter (1011759-08, 1011759-12) 44757 Type II 2009/01/15

SN090158 44817 Type II 2009/01/15

SN090159 45310 Type II 2009/01/15

SN090160 45351 Type II 2009/01/15

SN090161 St Jude Medical Epicor LP Connecting Cable 2008/012/010/061/001 FSCA 2009/01/20SN090162 BioMerieux Vironostika HIV Uni-Form II Ag/Ab 2008/011/019/061/001 FSCA 2009/01/20SN090163 Owen MumfordAutopen Classic 3ml, 1 unit (1-21 units) 2008/010/002/401/007 FSCA 2009/01/20SN090164 Siemens ADVlA Centaur, Centaur CP and Centaur XP, iPTH assay 2008/012/001/061/004 FSCA 2009/01/20SN090165 Biomet Sterile 1/3 Tubular Plates (85 mm x 7 Holes) 2008/012/002/291/002 FSCA 2009/01/20SN090166 ThermoFisher BO0351E, Tryptone soya broth, lot number 1045903 2008/012/015/601/004 FSCA 2009/01/20SN090167 Ortho Solutions FPS Locking Screws (14mm/18ms) 2008/010/017/401/001 FSCA 2009/01/20SN090168 ThermoFisher TPHA Test Kit 2008/012/022/051/001 FSCA 2009/01/20SN090169 BioMerieux Chocolate PolyViteX VCAT3 agar 2008/012/001/601/001 FSCA 2009/01/21SN090170 Diagnostica Stago STA - Cuvettes 2008/012/030/291/017 FSCA 2009/01/21SN090171 Abbott CELL-DYN Sapphire Haemoglobin Reagent Syringe 08H49-02 2008/012/022/601/003 FSCA 2009/01/21SN090172 Smiths Medical BCI 9200 Advisor Vital Signs Monitor 2008/012/030/061/006 FSCA 2009/01/21SN090173 CMS Software 4.3.1 through 4.40.00 2008/012/012/601/004 FSCA 2009/01/21SN090174 Sorin Mini Bypass Bag 2008/012/031/061/002 FSCA 2009/01/21SN090175 Days Healthcare Walking frame 2008/010/007/401/016 FSCA 2009/01/21SN090176 Olympus PK7300 blood grouping system 2008/012/023/051/002 FSCA 2009/01/21SN090177 Siemens Sentinel Apolipoprotein B 2009/001/005/061/005 FSCA 2009/01/21SN090178 Otto Bock Blizzard Active Wheelchair 2008/012/029/301/002 FSCA 2009/01/21SN090179 Bausch & Lomb Akreos Advanced Optics Aspheric Lens 2008/012/019/291/002 FSCA 2009/01/21SN090180 Maquet SERVO 300A Automode 2008/012/016/061/001 FSCA 2009/01/21

MHRABoston Scientific Hong Kong

LtdStryker Intouch Bed Model 2130 with positionpro (model: 2130-000-000), Intouch Bed Model 2140 with Positionpro (model: 2140-000-000) Health CanadaBiomet Microfixation A) Lactosorb Endobrow Lift Complete, B) Office Fixation Kit, C) 1.5/IMF Small Office Set Health Canada

Health CanadaHealth CanadaHealth CanadaHealth CanadaHealth CanadaHealth CanadaHealth CanadaHealth CanadaHealth CanadaHealth CanadaHealth CanadaHealth CanadaHealth CanadaHealth CanadaHealth CanadaHealth Canada

Philips A) Allura XER FD10/10, B) Allura XPER FD20/10 System, C) Integris H5000C Cardiology Imaging System (722016), D) Integris Allura (722043*), E) Allura XPER FD10, F) Allura XPER FD20 System

Health Canada

Philips A) Allura XPER FD20/10 System, B) Integris H5000C Cardiology Imaging System (722016), C) Integris Allura (722043*), D) Allura XPER FD10, E) Allura XPER FD20 System Health Canada

Stryker A)Intouch Critical Care Bed Model 2130 (2130-000-000), B) Intouch critical Care Bed Model 2140 (2140-000-000) Health Canada

MHRAMHRAMHRAMHRAMHRAMHRAMHRAMHRAMHRAMHRAMHRAMHRAMHRAMHRAMHRAMHRAMHRAMHRAMHRAMHRA


http://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/_list/rec-ret_md-im_date_oct-dec_2008-eng.php










































SN090181 Philips Pulmonary Toolkit 2008/012/029/291/001 FSCA 2009/01/22SN090182 Medtronic MicroTargetingTM Drive System and Accessories 2008/012/030/291/011 FSCA 2009/01/22

SN090183 Baxter System 1000 Series of Hemodialysis Instruments with 4.D.0.3 or 4.D.0.4 Software 2009/001/013/291/003 FSCA 2009/01/22

SN090184 Kivi Uniloc wheelchair docking system AKE 04 2009/001/012/301/001 FSCA 2009/01/22

SN090185 N.A. Class II 2009/01/22

SN090186 GE Centricity Enterprise Web 3.0 software Z-0870-2009 Class II 2009/01/22

SN090187 Z-0869-2009 Class II 2009/01/22

SN090188 Siemens Ariste MV Digital Linear Accelerator Z-0857-2009 Class II 2009/01/22

SN090189 Dade Behring (a Siemens Company) Dimension EXL Clinical Chemistry System Z-0581-2009 Class II 2009/01/22

SN090190 Abbott Clinical Chemistry Bilirubin Calibrator Z-0580-2009 Class II 2009/01/22SN090191 Depuy (Johnson and Johnson) DELTA Xtend, Standard Humeral PE Cup Z-0532-2009 to Z-0539-2009 Class II 2009/01/22

SN090192 Z-0129-2009 Class II 2009/01/22

SN090193 Biomet Microplasty Elite Instruments Vanguard Slidex Femoral Block Z-0873-2009 to Z-0882-2009 Class II 2009/01/22SN090194 Accuray RoboCouch Patient Support System (Model No 025007) Z-0856-2009 Class II 2009/01/22SN090195 VIBE Quantum Pulse machine Z-0582-2009 Class II 2009/01/22SN090196 Sterilmed various products Z-0546-2009 to Z-0577-2009 Class II 2009/01/22SN090197 Nutricia Enteral feeding pump MDA/2009/004 MDA 2009/01/23SN090198 Schulke & Mayr Mikrozid sensitive wipes 2008/011/019/061/022 FSCA 2009/01/23

SN090199 2009/001/005/061/007 FSCA 2009/01/23

SN0101100 Proact Medical Green System Duo Laryngoscope Handle 2008/010/024/401/007 FSCA 2009/01/23SN0101101 GE OEC 7600 and OEC 7700 2009/001/009/061/002 FSCA 2009/01/29SN0101102 Elekta Leksell GainmaPlan / Leksell SurgiPlan 2008/012/017/061/006 FSCA 2009/01/29SN0101103 Stryker HA Hip Stems: ABG II, Omnifit C-Taper, Accolade 2009/001/007/061/008 FSCA 2009/01/29SN0101104 Roche Hitachi 917 Modular Analytics 2008/011/026/291/009 FSCA 2009/01/29SN0101105 ThermoFisher Lactose peptone water with Durham's tube - BO0435B 2009/001/012/601/001 FSCA 2009/01/29SN0101106 Joint Replacement Instrumentation BiPolar Head 2009/001/008/061/005 FSCA 2009/01/29SN0101107 A2U Nano supportive seating system 2008/012/023/401/006 FSCA 2009/01/29SN0101108 Advanced Healthcare Technology Babypod II, Evo2 and Evo3 2008/012/012/401/010 FSCA 2009/01/29SN0101109 Siemens Somatom Definition AS 2008/012/012/291/003 FSCA 2009/01/29SN0101110 Siemens syngo Workflow MLR 2008/012/022/051/003 FSCA 2009/01/29SN0101111 Stryker Pneumo Sure XL High Flow Insufflator 2009/001/016/291/004 FSCA 2009/01/29

SN0101112 2009/001/014/601/004 FSCA 2009/01/29

SN0101113 Croma-Pharma Quatrix Acrylic Intraocular lenses with a preloaded injector 2009/001/012/291/017 FSCA 2009/01/29SN0101114 ThermoFisher Oxoid Staphytect Plus Dry Spot Kit 2008/010/017/061/003 FSCA 2009/01/29SN0101115 Invacare Action® 2000 Manual Wheelchair 2008/010/020/401/012 FSCA 2009/01/29SN0101116 Philips PCR Eleva 2009/001/021/291/004 FSCA 2009/01/29

SN0101117 Coloplast Philips Catheter, 1Eye, Female Metric Thread (Catalogue no. AG55) Coloplast (HK) Ltd N.A. Firm Initiated Field Action 2009/01/30

SN0101118 Bausch & Lomb High Speed Vitrectomy cutter product (CX4804) Bausch & Lomb N.A. Firm Initiated Field Action 2009/01/30

SN0101119 Stryker Endoscopy FloControl Arthroscopy Pump Integrated Tubing (Model no 0350600006) Z-0652-2009 Class II 2009/01/30

SN0101120 Stryker Vision 3 Flat Panel Shroud (Part#0682-000-414, 0682-000-415 and 0682-000-416) Z-0625-2009 Class II 2009/01/30

SN0101121 Stryker Dri-Lok Disposable Cannula Z-0868-2009 Class II 2009/01/30SN0101122 Philips Vertical drive brake on patient supports Z-0597-2009 Class II 2009/01/30

MHRAMHRAMHRAMHRA

Varian Medical Systems Eclipse 8.5 (build 8.2.2X) systems with distributed Calculation Framework (DCF) 8.2.22 (Model no H48) FDA

FDAStryker Triathlon PKR Insert X3#1 LM/RL-8mm (Catalog no.: 5630-G-108) and Triathlon PKR Insert X3#1 RM/LL -12mm (Catalog no: 5630-G-122) FDA

FDAFDAFDAFDA

Beckman Coulter Cytomics FC 500 Flow Cytometry System with CXP Software Version 2.2 (Part no 626553) FDA

FDAFDAFDAFDA

MHRAMHRA

Cardinal Health Alaris GP LVP (Model 80063UN01), Alaris GP Guardrails Volumetric Pump (Model 80263UN01-G) MHRA

MHRAMHRAMHRAMHRAMHRAMHRAMHRAMHRAMHRAMHRAMHRAMHRA

Gen-Probe ACCUPROBE Group B Streptococcus kit, ACCUPROBE M. tuberculosis Complex, ACCUPROBE M. avium Complex MHRA

MHRAMHRAMHRAMHRA

FDA

FDAFDAFDA










































SN0101123 Philips NeuViz Dual Multi-Slice Computed Tomography (CT) Scanner System (software) Z-0001-2009 Class II 2009/01/30

SN0101124 Accuray CyberKnife Robotic Radiosurgery System Z-0629-2009 Class II 2009/01/30SN0101125 GE Innova 2100IQ, 3100/3100IQ, 4100/4100IQ Z-0473-2009 to Z-0475-2009 Class II 2009/01/30SN0101126 Cardinal Health Esmark Elastic Bandage Z-0615-2009 to Z-0616-2009 Class II 2009/01/30SN0101127 INGfertility Pre Isotonic Personal Lubricant labeled PRE' Patient Lubricant Z-0626-2009 Class II 2009/01/30SN0101128 Alimed Gait Belt (Transfer Aid) (Model 72108, 72109) Z-0598-2009 Class II 2009/01/30SN0101129 Quantimetrix QuanTscopics Urine Microscopics Contro Z-0513-2009 to Z-0516-2009 Class II 2009/01/30SN0101130 Hill- Rom 70 Semi-Electric Bed (Model HS-968) Z-0506-2009 Class II 2009/01/30SN0101131 Ansell Healthcare Products Conform XT - Gloves (Model: 69318) 45563 Type II 2009/01/30SN0101132 Ossur HF ReSolve Open Back Halo Ring 45100 Type II 2009/01/30SN0101133 Maquet Reservoirs (BEQ-VHK 2001) 45565 Type II 2009/01/30SN0101134 Styker Dri-Lok Disposable Cannulas 45616 Type II 2009/01/30SN0101135 BHM Medical Ergolift, Ergolift-2 45626 Type I 2009/01/30SN0101136 Roche Diagnostics Process System Manager (Model: 3009696001) 45358 Type I 2009/01/30SN0101137 Baxter Colleague Volumetric Infusion Pump (Model: 2M8151K) 41402 Type II 2009/01/30

SN0101138 Harvest Technologies Autologous Platelet Concentrate System (Model: APC-201) 45706 Type II 2009/01/30

SN0101139 45311 Type II 2009/01/30

SN0101140 White Peaks Dental Systems Origin YZ Zirconia Blocks, Origin YZ Zirconia Disc 44705 Type II 2009/01/30

SN0101141 MC Healthcare Products QP2508 Hand Pendant (Model: HB43-U010-00/01 45786 Type II 2009/01/30

SN0101142 Smiths Medical Medfusion Syringe Pump (Model: 3500-306, 3500-415) 45802 Type II 2009/01/30

FDAFDAFDAFDAFDAFDAFDAFDA

Health CanadaHealth CanadaHealth CanadaHealth CanadaHealth CanadaHealth CanadaHealth CanadaHealth Canada

Philips A) Multidiagnost Eleva - Image Intensifier (70832), B) Multidiagnost Eleva - Flat Detector (70834), C) Omnidiagnost Eleva (Model: 708027) Health Canada

Health Canada























Local Agent



N.A. N.A.

Gold Pacific Enterprises 2544 2602

Siemens Healthcare Diagnostic Limited 2810 7533N.A. N.A.N.A. N.A.


Johnson & Johnson Medical (HK) 2738 6027N.A. N.A.N.A. N.A.

GE Medical Systems Hong Kong Ltd. 2783 1838Siemens Healthcare Diagnostic Limited 2810 7533

N.A. N.A.N.A. N.A.

Stryker China Ltd 2518 6915N.A. N.A.

N.A. N.A.

N.A. N.A.N.A. N.A.

Siemens Healthcare Diagnostic Limited 2810 7533N.A. N.A.


Zimmer PTE Ltd. (Hong Kong branch) 2992 0968N.A. N.A.


N.A. N.A.N.A. N.A.N.A. N.A.

N.A. N.A.


GE Medical Systems Hong Kong Ltd. 2783 1838Siemens Healthcare Diagnostic Limited 2810 7533

N.A. N.A.

N.A. N.A.

N.A. N.A.




N.A. N.A.



N.A. N.A.

Sanko Medical Systems (HK) LTD 238400688Direct Health LTD N.A.

Medtronic International, Ltd. 2919 1300Philips Health Care (Great China) 2821 5480Bristol-Myers Squibb (HK) LTD. 2510 6146

N.A. N.A.Maquet Hong Kong LTD. 2393 9511

Philips Health Care (Great China) 2821 5480Stryker China Ltd 2518 6915

Coloplast (HK) LTD 3628 7427Roche Diagnostics (Hong Kong) Ltd 2485 7510

Smith & Nephew LTD 2648 7700Synthes International Ltd. N.A.

N.A. N.A.Biomerieux China Ltd. (HK office) 2356 7033





N.A. N.A.Biomerieux China Ltd. (HK office) 2356 7033

N.A. N.A.Siemens Healthcare Diagnostic Limited 2810 7533

Goodman Medical Supplies Ltd 2332 4455N.A. N.A.N.A. N.A.N.A. N.A.

Biomerieux China Ltd. (HK office) 2356 7033Healthpro Technology Co. Ltd N.A.

Abbott Laboratories LTD. 2593 2211Goodman Medical Supplies Ltd 2332 4455


Olympus Hong Kong and China Limited 2170 5603Siemens Healthcare Diagnostic Limited 2810 7533

N.A. N.A.Bausch & Lomb (Hong Kong ) Ltd 2213 3371



Philips Health Care (Great China) 2821 5480Medtronic International, Ltd. 2919 1300


N.A. N.A.

Varian Medical Systems Pacific Inc. 2724 2836GE Medical Systems Hong Kong Ltd. 2783 1838




Abbott Laboratories LTD. 2593 2211Johnson & Johnson Medical (HK) 2738 6027


N.A. N.A.Accuray Asia Ltd 2247 8628

N.A. N.A.N.A. N.A.N.A. N.A.N.A. N.A.

N.A. N.A.

N.A. N.A.GE Medical Systems Hong Kong Ltd. 2783 1838

N.A. N.A.Stryker China Ltd 2518 6915

Roche Diagnostics (Hong Kong) Ltd 2485 7510N.A. N.A.N.A. N.A.N.A. N.A.N.A. N.A.

Siemens Healthcare Diagnostic Limited 2810 7533Siemens Healthcare Diagnostic Limited 2810 7533


N.A. N.A.



Coloplast (HK) LTD 3628 7428

Bausch & Lomb (Hong Kong ) Ltd 2213 3371



Stryker China Ltd 2518 6915Philips Health Care (Great China) 2821 5480



Accuray Asia Ltd 2247 8628GE Medical Systems Hong Kong Ltd. 2783 1838

N.A. N.A.N.A. N.A.N.A. N.A.N.A. N.A.N.A. N.A.N.A. N.A.N.A. N.A.

Maquet Hong Kong LTD. 2393 9511Stryker China Ltd 2518 6915

Arjo Huntleigh (Hong Kong) Ltd. 2508 1416Roche Diagnostics (Hong Kong) Ltd 2485 7510


N.A. N.A.


N.A. N.A.

N.A. N.A.

N.A. N.A.


Monthly Summary of Medical Device Safety Alerts - December 2008*Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada


SN081201 Autoadapt DriveLOC and Carosafe II 2008/003/006/301/002 FSCA 01-Dec-08

SN081202 Liko LikoScale 200 2008/005/029/401/009 FSCA 01-Dec-08

SN081203 Diamed ID DiaScreen Prophylax 2008/011/021/061/012 FSCA 01-Dec-08

SN081204 ThermoFisher Staphaurex Plus 2008/011/024/601/002 FSCA 01-Dec-08

SN081205 2008/011/021/291/003 FSCA 01-Dec-08

SN081206 Zimmer Silhouette Axial Torque Wrench 2008/011/021/061/010 FSCA 01-Dec-08

SN081207 Edwards Lifesciences Aquarius software operating manuals 2008/011/024/291/007 FSCA 01-Dec-08

SN081208 Siemens Syngo Dynamics version 4.2, 5.x, 6.0 2008/009/008/061/001 FSCA 02-Dec-08

SN081209 Integra LifeSciences Uni-CP Compression Forceps (Spreader) (Catalog no 339001ND) Z-0307-2009 Class II 04-Dec-08

SN081210 Boston Scientific RF Ablation System Foot Switch N/A Firm Initiated Field Action 05-Dec-08

SN081211 Boston Scientific Flextome Cutting Balloon w/Over-the-Wire Delivery System N/A Firm Initiated Field Action 05-Dec-08

SN081212 Johnson and Johnson ENDOPATH Electrosurgery Probe Plus II N/A Firm Initiated Field Action 05-Dec-08

SN081213 Medtronic EnTrust® Implantable Cardioverter Defibrillators 2008/011/021/061/005 FSCA 08-Dec-08

SN081214 Otto Bock Healthcare 3R66 – Modular Polycentric Knee Joint 2008/011/006/301/001 FSCA 08-Dec-08

SN081215 Varian Linear accelerators other than Clinac N/A Firm Initiated Field Action 10-Dec-08

SN081216 GE Healthcare CT/e and HiSpeed X/I families of Computed Tomography systems N/A Firm Initiated Field Action 10-Dec-08

SN081217 2008/011/028/061/015 FSCA 15-Dec-08

SN081218 AMO Healon D Ophthalmic Viscosurgical Device (Lot No. UD30654) Z-0343-2009 Class I 15-Dec-08

SN081219 Integra NeuroSciences Gravity Compensating Accessory Z-0458-2009 Class I 15-Dec-08

SN081220 Z-0286-2009 Class II 15-Dec-08

SN081221 Siemens AXIOM Artis System Z-0312-2009 to Z-0317-2009 Class II 15-Dec-08

SN081222 Siemens syngo MultiModality WorkPlace (MM WP), software product (Model No 10140720) Z-0324-2009 Class II 15-Dec-08

SN081223 Terumo Sarns Sternal Saw II System Power Unit Z-0358-2009 to Z-0359-2009 Class II 15-Dec-08


MHRA

MHRA

MHRA

MHRAPhilips Omni, Multi and Easy Diagnost Systems using GCF Velara Generator with Tube Grid switch MHRA

MHRA

MHRA

MHRA

FDA




MHRA

MHRAVarian Medical Systems

Pacific Inc.

GE Medical Systems Hong Kong Ltd.

Baxter COLLEAGUE Triple Channel Mono, and CXE Volumetric Infusion Pumps 2M8153K and 2M9163 MHRA

FDA

FDAPosey Synthetic Leather and Biothane Waist and Wrist Restraints (Catalog No 2217SL and 2217B) FDA

FDA

FDA

FDA




















SN081224 Medtronic 5F, 6F, 7F BardSelect 1cm Percutaneous Catheter Introducer Set Z-0441-2009 to Z-0444-2009 Class II 15-Dec-08

SN081225 Johnson and Johnson STERRAD NX Sterilizer (Product Code 10033) Z-0484-2009 Class II 15-Dec-08

SN081226 Radiometer Calibrator 1 Solution for the ABL700 Series Z-0457-2009 Class II 15-Dec-08

SN081227 Cardinal Health GSI Audera (version 2.6 Software) System Z-0195-2009 Class II 15-Dec-08

SN081228 Stryker Pain Pump 2 Blockaid (0575-100-000) 44921 Type II 17-Dec-08

SN081229 Smiths Medical Disposable Norothermic IV Admin. Sets (DI-100, DI-50) 44870 Type II 17-Dec-08

SN081230 Oxoid Filteredhorse Serum (SR0035C) 44449 Type II 17-Dec-08

SN081231 BHM Battery Model NDA 0200-20 45060 Type II 17-Dec-08

SN081232 Technidata TD-Synergy Software (TD-SYS-01) 44744 Type II 17-Dec-08

SN081233 Orasure Intercept Mirco-Plate EIA Kit (Model: 61452, 61454, 61456) 44505 Type II 17-Dec-08

SN081234 Hill-Rom Liko Uno 100, 101, 102 Patient Lift 44701 Type II 17-Dec-08

SN081235 InteleViewer module of the Intel PACS and Intele Viewer Workstation (V3-X-X) 44646 Type II 17-Dec-08

SN081236 44525 Type II 17-Dec-08

SN081237 Clinical Instruments Carotid Shunt Outlying / Inlying with T-Port 44867 Type II 17-Dec-08

SN081238 2008/011/027/601/001 FSCA 17-Dec-08

SN081239 Siemens CT Syngo Dual Energy Viewer 2008/010/031/061/006 FSCA 17-Dec-08

SN081240 Fresenius Medical Care 5008 dialysis machine 2008/012/001/061/001 FSCA 17-Dec-08

SN081241 Smiths Medical Deltec Cozmo Insulin Pump Model number 1800 2008/011/027/061/013 FSCA 17-Dec-08

SN081242 Terumo Sarns Level Sensor II Pads (Ref 195240) Z-0311-2009 Class II 18-Dec-08

SN081243 Terumo Advanced Perfusion System 1 (Model no.: 801040, 801041, 816570, 816571) Z-0354-2009 to Z-0357-2009 Class II 18-Dec-08

SN081244 GE Centricity PACS RA1000 Workstation Z-0460-2009 Class II 18-Dec-08

SN081245 Siemens Dade Behring Dimension Enzymatic Creatinine Flex reagent cartridge, DF270 Z-0485-2009 Class II 18-Dec-08

SN081246 Fisher & Paykel Healthcare RT240 Adult Breathing Circuit Kit Z-0414-2009 Class II 18-Dec-08

SN081247 Acumed Modular Shoulder Body Assembly Z-0477-2009 Class II 18-Dec-08

SN081248 Promega RNAgents Total RNA Isolation System (Cat. #Z5110) Z-0483-2009 Class II 18-Dec-08

SN081249 2008/011/024/291/001 FSCA 19-Dec-08

FDA

FDA

FDA

FDA

Health Canada

Health Canada

Health Canada

Health Canada

Health Canada

Health Canada

Health Canada

Health Canada

Philips EGM Essential Gas Module (GI M1013A, G5 M1019A), Intellivue Patient Monitoring Sys. (M8002A, M8004A, M8007A), Intellivue Patient Monitor (M8105A, M8105AT) Health Canada

Health Canada

Beckman Coulter UniCel Dxl Access Immunoassay Systems Wash Buffer II Lots 70662 and 70637 MHRA

MHRA

MHRA

MHRA

FDA

FDA

FDA

FDA

FDA

FDA

FDA

Medtronic LIFEPAK®9, LIFEPAK 9P, LIFEPAK 12, LIFEPAK 20/20e External Sterilizable Paddles and Pediatric Paddles MHRA




























SN081250 Sun Med Greenline/D Maclntosh No. 3 Laryngoscope Blades N/A Class I 22-Dec-08

SN081251 Bard feeding kits (containing ConMed grasping snares) N/A Firm Initiated Field Action 22-Dec-08

SN081252 Medtronic Reveal DX Insertable Cardiac Monitor (ICM) Medtronic International Ltd N/A Firm Initiated Field Action 23-Dec-08

SN081253 Joerns Healthcare Oxford disposable slings MDA/2008/088 MDA 23-Dec-08

SN081254 Stryker Custom Cranial Implant Kits N/A Class I 29-Dec-08

SN081255 Boston Scientific iLab Ultrasound Imaging System, models 120INS and 240INS Z-0338-2009 Class II 30-Dec-08

SN081256 Z-0412-2009 to Z-0413-2009 Class II 30-Dec-08

SN081257 Beckman Coulter Vidiera NsP Nucleic Sample Preparation Z-0454-2009 Class II 30-Dec-08

SN081258 Alfa Wassermann ACE and ACE Alera Hemoglobin A1C Z-0482-2009 Class II 30-Dec-08

SN081259 FHC MicroTargeting Electrode Z-0497-2009 to Z-0498-2009 Class II 30-Dec-08

SN081260 Arjo Maxi Move, Model NDA0200-20 Batteries Pack Z-0503-2009 Class II 30-Dec-08

SN081261 Bk Medical Single-use sterile puncture attachment UA1256-U Z-0504-2009 Class II 30-Dec-08

SN081262 Boston Scientific Convoy Advanced Delivery Sheath Kits N/A Firm Initiated Field Action 30-Dec-08

SN081263 Boston Scientific Gold Probe Single-Use Bi-Polar Electrohemostasis Catheters N/A Firm Initiated Field Action 30-Dec-08

SN081264 Wescott Medical Sae-Flo MD Extension Set with Y-Connector 2008/010/022/601/001 FSCA 31-Dec-08

SN081265 Siemens Leonardo Workstation 2008/004/010/061/006 FSCA 31-Dec-08

SN081266 Biotronik EDP 30/A 2007/002/007/401/009 FSCA 31-Dec-08

FDABard Pacific Health Care Co

Ltd

MHRA

FDA

FDAArjo Maxi 500 Patient Lift with 2-Point Spreader Bar and Scale, Manual 4-Point DPS and scale FDA

FDA

FDA

FDA

FDA

FDA



MHRA

MHRA

MHRA

http://www.fda.gov/cdrh/recalls/recall-042707a.html














Local Agent

N/A N/A

N/A N/A

DIAMED-CHINA LTD. 251 262 38

N/A N/A

Philips Healthcare - Great China 2821 5480


N/A N/A


N/A N/A




Medtronic International, Ltd. 2907 5911

N/A N/A




AMO Asia Limited 2480 3330

N/A N/A

N/A N/A








N/A N/A

N/A N/A


Smiths Medical (S.E. Asia) Ltd. 2317 0988

South East Chemical & Instrument Ltd 28026333

BHM Medical Inc. N/A

N/A N/A

N/A N/A

N/A N/A

N/A N/A


N/A N/A



N/A N/A






N/A N/A

N/A N/A

Bio-Gene Technology Ltd 2646 6101



N/A N/A

Bard Pacific Health Care Co Ltd 886-2-2503-1900


N/A N/A



Arjo Huntleigh (Hong Kong) Ltd 2508 9553


N/A N/A

N/A N/A


N/A N/A



N/A N/A


N/A N/A


Monthly Summary of Medical Device Safety Alerts - November 2008*Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada


SN081101 N/A Class I 2009/11/03

SN081102 2008/010/027/601/002 FSCA 2008/11/03

SN081103 Smiths Medical Wallace Oocyte Recovery Needle 2008/010/022/061/011 FSCA 2008/11/03

SN081104 Pride Jazzy 1121 power chairs 2008/004/024/401/003 FSCA 2008/11/03

SN081105 TomoTherapy Hi-Art System 2008/010/014/061/018 FSCA 2008/11/03

SN081106 Teleflex Medical Great Ormond Street Tracheostomy Cannula Set 2008/006/018/061/013 FSCA 2008/11/03

SN081107 Cardiac Science Powerheart AEDs 2008/002/011/061/010 FSCA 2008/11/03

SN081108 TerumoTenderflow Pediatric Arterial Cannula 2008/010/028/061/006 FSCA 2008/11/03

SN081109 Biomet Various AGC /5+ Reamer /Hiploc Instrument cases 2008/010/027/601/003 FSCA 2008/11/03

SN081110 Biomet EZloc Femoral Fixation 9-10mm Standard Length -- 904781 2008/010/014/601/004 FSCA 2008/11/03

SN081111 Abbott Voyager NC Coronary Dilatation Catheter (4.5mm diameter) Abbott Laboratories Ltd N/A Firm Initiated Field Action 2008/11/05

SN081112 Tyco Healthcare (Covidien) ReliOn Insulin Syringes N/A Press Release 2008/11/06

SN081113 Medtronic DBS" 3387S-40 Lead Kit for Deep Brain Stimulation Z-0184-2009 to Z-0187-2009 Class II 2008/11/07

SN081114 B Braun Smallbore T-Port Extension Set (Item no 474515) ( Z-0199-2009 Class II 2008/11/07

SN081115 Siemens Axiom Aristos FX Multipurpose Radiography System (Model no 7414803) Z-0163-2009 Class II 2008/11/07

SN081116 Z-0086-2009 Class II 2008/11/07

SN081117 Siemens Coherence Therapist Systems Z-0089-2009 to Z-0099-2009 Class II 2008/11/07

SN081118 Z-0102-2009 Class II 2008/11/07

SN081119 Z-0111-2009 Class II 2008/11/07

SN081120 Siemens Artiste MV System (Part no 8139789) Z-0116-2009 Class II 2008/11/07

SN081121 Stryker Osteosynthesis Reduction Spoon (Product Code 1806-0125) Z-0191-2009 Class II 2008/11/07

SN081122 Stryker Ray TFC Device with End Caps Z-0151-2009 Class II 2008/11/07


vibe Technologies, Vibrational Integrated Biophotonic Energizer (VIBE) Machine Multi-Frequency Field Generator FDA

Beckman Coulter UniCel® DxI® 800 and UniCel DxI 600 Access® Immunoassay Systems and UniCel DxC 880i SYNCHRON® Access Clinical System MHRA

MHRA

MHRA

MHRA

MHRA

MHRA

MHRA

MHRA

MHRA

FDA

FDA

FDA

FDA

Siemens Acuson/Sonovista X300 Ultrasound systems (Software version 2.0.1 - 2.0.05, 3.0.01 and 3.0.02 FDA

FDA

Siemens Syngo Imaging with versions VB20B, VB20D, VB20G, VB25B,VB30A, VB30A-SP1 and VB30A-SP2 (Model no 10014063) FDA

Siemens Acuson X300 Ultrasound Systems (Model no. 10037409, 10038837, 10348531, 10132987, 10133170, 10348532, 10348533) FDA

FDA

FDA

FDA











http://www.fda.gov/bbs/topics/NEWS/2008/NEW01911.html












SN081123 Z-0112-2009 Class II 2008/11/10

SN081124 Baxter Auto Syringe AS50 Infusion Pump (Product Code 1M8550) Z-0152-2009 Class II 2008/11/10

SN081125 Roche Diagnostic LDL_C, IRON2, CREP2, STFR, HDLC3, ALBT2, NAPA2 Z-0006-2009 to Z-0012-2009 Class II 2008/11/10

SN081126 Z-0165-2009 Class II 2008/11/10

SN081127 Philips Respiratory Gating System (Model # 455011203131 and 455011203191) Z-0132-2009 Class II 2008/11/10

SN081128 Philips M3811B Telemonitoring Clinical Review Software (version Build 1.1.2.11d, B.02.07) Z-0100-2009 Class II 2008/11/10

SN081129 Z-0162-2009 Class II 2008/11/10

SN081130 Facet Technologies Premier Value Lancing Device (UPC Code: 840986016707) Z-0174-2009 Class II 2008/11/10

SN081131 Biomet brand Modular Microplasty Cup Inserter (Model 31-400600) Z-0181-2009 Class II 2008/11/10

SN081132 Pointe Scientific Liquid AST (SGOT) Reagent Set, AST R1 Reagent Z-0171-2009 Class II 2008/11/10

SN081133 Maquet Accessory Head Rest for Alphastar Operating Tables (USA Part no 1130 67FO) Z-0161-2009 Class II 2008/11/10

SN081134 Z-0153-2009 to Z-0155-2009 Class II 2008/11/10

SN081135 Intraop Medical Mobetron Model 1000, mobile electron linear accelerator Z-0014-2009 Class II 2008/11/10

SN081136 Z-0015-2009 to Z-0019-2009 Class II 2008/11/10

SN081137 Hill-Rom Envision E700 Low Airloss Therapy Surface Z-0088-2009 Class II 2008/11/10

SN081138 Applied Medical Separator Abdominal Access System, Lap Banding Kit, Lap Roux-EN-Y Kit Z-0023-2009 to Z-0029-2009 Class II 2008/11/10

SN081139 Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System Z-0035-2009 to Z-0085-2009 Class II 2008/11/10

SN081140 Cook Endoscopy Zilver Expandable Metal Biliary Stent System, ZILBS-10-6 Z-0113-2009 Class II 2008/11/10

SN081141 Joerns Healthcare Mermaid, Dipper and Ranger bath hoists MDA/2008/079 MDA 2008/11/10

SN081142 Tosoh Bioscience TSKgel G8 Variant HSi 2008/011/003/061/010 FSCA 2008/11/10

SN081143 Roche Diagnostics MODULAR ANALYTICS Software version 08.03 2008/010/030/061/016 FSCA 2008/11/10

SN081144 Siemens Syngo Imaging 2008/010/031/061/003 FSCA 2008/11/10

SN081145 CODAN Pressure Monitoring Kit STP-90R 2008/002/028/401/002 FSCA 2008/11/10

GE Centricity Perinatal (formerly Quantitative Sentinel) System - Fluid Total Precision Software FDA

FDA

FDA

Roche/Hitachi Modular E Module immunoassay analyzer (GMMI Nos. 04998642001 and 03617505001) FDA

FDA

FDA

Smith & Nephew GlobTek, Inc. Power Supply for Medical Use (Par no: TR9CE4000LCP-Y-MED Model GTM21097-5012) FDA

FDA

FDA

FDA

FDA

Allez Spine Laguna Pedicle Screw System, Del Mar Pedicle Screw System, Cross Connectors FDA

FDA

Medline Latex Free C- Section CDS-LF, Vaginal Delivery CDS-LF, Labor Kit & Postpartum CDS-LF, Mom/Baby Admit Kit-LF FDA

FDA

FDA

FDA

FDA

MHRA

MHRA

MHRAMHRA

MHRA

























SN081146 Stryker Humerus Head Fixed and HMRS - Distal Humerus Cone 2008/010/015/061/005 FSCA 2008/11/11

SN081147 Biomet AGC V2 Total Knee Moulded ArComTibial Components 2008/009/025/401/008 FSCA 2008/11/11

SN081148 ThermoFisher BO0077M, Tryptone soya broth 2008/011/005/601/005 FSCA 2008/11/11

SN081149 GE Healthcare Signa MR 2239500, 5116064 and 5118162 2008/011/004/051/004 FSCA 2008/11/11

SN081150 Bio-Rad Variant II Turbo Hemoglobin Testing System with CDM 4.0 2008/011/005/061/009 FSCA 2008/11/11

SN081151 2008/008/007/061/009 FSCA 2008/11/12

SN081152 Maquet Pedal 1009.81 for operating tables 2008/011/003/061/013 FSCA 2008/11/12

SN081153 KYMCO Healthcare Midi XL 2008/010/027/261/001 FSCA 2008/11/12

SN081154 Days healthcare Strider Maxi and Strider Midi 4+ 2008/010/023/301/002 FSCA 2008/11/12

SN081155 Sunrise Medical OXFORD Midi 150A lifts 2008/004/014/401/003 FSCA 2008/11/13

SN081156 Marshall Products adult and paediatric manual resuscitators 2008/010/029/401/001 FSCA 2008/11/13

SN081157 TSCI Fluido SA 200 2008/011/006/051/008 FSCA 2008/11/13

SN081158 Biomet Vanguard Width Checker 67.5 / 70 / 75 40888 Type II 2008/11/14

SN081159 Siemens AG Syngo Imaging (Model 10014063) 44245 Type II 2008/11/14

SN081160 B-K Medical Single Use Sterile Puncture UA 1256-U 44063 Type II 2008/11/14

SN081161 Roche Hitachi D-Dimer 43711 Type II 2008/11/14

SN081162 Kerr Premise Unidose 44081 Type II 2008/11/14

SN081163 Ondal Stryker Vision 3 Elect Mon Shroud 44076 Type II 2008/11/14

SN081164 Ondal Flat Panel/Navigation Arm 44179 Type II 2008/11/14

SN081165 Biomet Microfixation Lactosorb 1.5MM 8Hole STR EXT Plate 43369 Type II 2008/11/14

SN081166 GE Centricity PACS Software 42408 Type II 2008/11/14

SN081167 Medtronic Synchromed EL, Synchromed II infusion pumps 44005 Type II 2008/11/14

SN081168 Terumo Advanced Perfusion System 1 42752 Type II 2008/11/14

SN081169 Synthes sternal Fixation System - Cable Ferrule 44393 Type II 2008/11/14

SN081170 Siemens Somatom Sensation / Cardiac 64 44298 Type II 2008/11/14

SN081171 Tripath Prepstain System 44291 Type II 2008/11/14

SN081172 Medrad 3.0 T Prostat eCoil 44234 Type II 2008/11/14

MHRA

MHRA

MHRA

MHRA

MHRA

Bio-Rad Variant II Turbo HCook Zenith Flex AAA Endovascular Graft emoglobin Testing System with CDM 4.0 MHRA

MHRA

MHRA

MHRA

MHRA

MHRA

MHRA

Health Canada

Health Canada

Health Canada

Health Canada

Health Canada

Health Canada

Health Canada

Health Canada

Health Canada

Health Canada

Health Canada

Health Canada

Health Canada

Health Canada

Health Canada





























SN081173 Terumo Level Sensor Transducer 43401 Type II 2008/11/14

SN081174 TomoTherapy Hi-Art System 44265 Type II 2008/11/14

SN081175 Gambro Prismaflex system 44403 Type II 2008/11/14

SN081176 Gerno Model 35X Proflexx Stretcher 44082 Type II 2008/11/14

SN081177 44259 Type II 2008/11/14

SN081178 Pascal Siltrax Plus 8 Gingival Retraction Cord 43384 Type II 2008/11/17

SN081179 ACS Holter Reporter Master VII Analyzer 43854 Type II 2008/11/17

SN081180 Angio 3-0 Nylon Suture Product 44163 Type I 2008/11/17

SN081181 Thomas Medical Products 18 gage XTW needles Z-0131-2009 Class II 2008/11/17

SN081182 7F Bard SSV 13 cm Split Sheath with Valve and sideport (Catalog No: 808700) Z-0280-2009 Class II 2008/11/17

SN081183 Sunquest Laboratory versions 5.3, 5.4, 6.1, 6.2 and 6.3 Z-0207-2009 Class II 2008/11/17

SN081184 Z-0208-2009 to Z-0211-2009 Class II 2008/11/17

SN081185 Iverness Medical BioStar OIA FLU AB (Catalog 90007) Z-0212-2009 Class II 2008/11/17

SN081186 Pointe Scientific Liquid Glucose HEX (R1); HEX (R2); HEX; HEXO Reagent Sets Z-0219-2009 to Z-0224-2009 Class II 2008/11/17

SN081187 Porter Instrument Bag Tee Assembly Model (P1407A) Z-0228-2009 Class II 2008/11/17

SN081188 Biomet Microfixation HT X-Drive Screw Z-0282-2009 Class II 2008/11/17

SN081189 Advanced Bionics Preision Charger 1.0 (Model # SC-5300) Z-0271-2009 Class II 2008/11/17

SN081190 Alcon PurePoint System Operator's Manual (Catalog no 8065751131 Rev. B) Z-0274-2009 Class II 2008/11/17

SN081191 Terumo Sarns Level Sensor II (Yellow and Red) (Part # 195215 and # 195274) Z-0295-2009 to Z-0296-2009 Class II 2008/11/17

SN081192 TERUMO Advanced Perfusion System 1 Base (Model 801763 and 801764) Z-0203-2009 to Z-0204-2009 Class II 2008/11/17

SN081193 Siemens AXIOM Artis and Artis zee Z-0193-2009 to Z-0194-2009 Class II 2008/11/17

SN081194 Animas (Johnson & Johnson ) One Touch Ping Glucose Monitoring System Z-0283-2009 Class II 2008/11/17

SN081195 Stryker Hipstar V40 Femoral Stem Howemedica Z-0227-2009 Class II 2008/11/17

SN081196 Gyrus ACMI (Olympus) dissector PlasmaKnife (DPK) (Catalog no 7035-3005) Z-0273-2009 Class II 2008/11/17

SN081197 2008/009/025/061/013 FSCA 2008/11/17

Health Canada

Health Canada

Health Canada

Health Canada

BC Unicel DXC 6001 Assay Protocol File, Access Immunoassay system Protocol file, Access System 2 Protocol File, Sysnchron LXI 725 Assay Protocol file Health Canada

Health Canada

Health Canada

Health Canada

FDA

FDA

FDA

Drummond Scientific Iris Sample Processing SafeCrit 75mm and 40mm Tubes, Separation Technology ClearCRIT Capillary Tubes FDA

FDA

FDA

FDA

FDA

FDA

FDA

FDA

FDA

FDA

FDA

FDA

FDA

Philips Intera, Achieva and Panorama HFO (Philips MR), 3160 (Precess) MRI Patient Monitoring System (Invivo) MHRA



























SN081198 Unomedical Unilect 4831Q and 4841P Short Term Monitoring Electrodes 2008/010/023/061/011 FSCA 2008/11/18

SN081199 Siemens ADVIA Centaur® and ACS:180® Systems 2008/011/004/061/009 FSCA 2008/11/18

SN0811100 B Braun Diacap Ultra Dialysis Fluid and Online Filter, 7107366 and 7107365 2008/010/007/061/011 FSCA 2008/11/18

SN0811101 Stryker V40 ORTHINOX femoral head 28/-4 mm & 28/0 mm 2008/010/030/061/008 FSCA 2008/11/18

SN0811102 Johnson & Johnson Sterrad 100S Sterilizers N/A Firm Initiated Field Action 2008/11/19

SN0811103 Baxter Healthcare Ltd N/A Firm Initiated Field Action 2008/11/19

SN0811104 Beckman Coulter Power Processor with LX Connections, 6605741 2008/011/005/601/001 FSCA 2008/11/20

SN0811105 Clinical Innovations ClearView Uterine Manipulator 2008/011/013/061/003 FSCA 2008/11/20

SN0811106 Coloplast EasiCath Catheter and EasiCath Luer Lock Catheter 2008/011/011/291/008 FSCA 2008/11/20

SN0811107 Stanmore Implants METS Femoral Shaft 2008/011/014/061/012 FSCA 2008/11/20

SN0811108 Boston Scientific NAMIC Custom Angiographic Kit (REF/Catalog#60190254) Z-0287-2009 Class II 2008/11/21

SN0811109 Z-0214-2009 Class II 2008/11/21

SN0811110 Z-0218-2009 Class II 2008/11/21

SN0811111 Smith & Nephew SOFTSILK 1.5 SCREW, 8mm x 20mm 2008/011/014/061/008 FSCA 2008/11/21

SN0811112 Codman, A J&J Archimedes implantable infusion pump 2008/004/021/061/008 FSCA 2008/11/21

SN0811113 Comis Orthopaedics MIHR Modular Femoral Head Sleeve Size 0, product code 028-10-2 2008/009/002/061/011 FSCA 2008/11/21

SN0811114 Philips IntelliVue Patient Monitors (the table mount, part# M8000-64100) 2008/011/019/061/021 FSCA 2008/11/24

SN0811115 GE Giraffe OmniBed (Cleaning & Care Guidelines) 2008/011/018/601/002 FSCA 2008/11/24

SN0811116 Phadia Varelisa U1RNP Antibodies Kit (model 17096) 44383 Type II 2008/11/24

SN0811117 Siemens Axiom Luminos DRF (Model 10252047) 44442 Type II 2008/11/24

SN0811118 Fisher and Paykel RT240 & RT340 Adult Breathing Circuit 44527 Type II 2008/11/24

SN0811119 Smiths Potex Blue Line Ultra Tracheostomy Kit (Model 100/812/070) 44440 Type II 2008/11/24

SN0811120 Siemens Symbia T Series (Model 10275009) 44551 Type II 2008/11/24

SN0811121 44535 Type II 2008/11/24

SN0811122 Bard WIZARD Dual Port Low Profile Replacement Gastrostomy Device 2008/011/003/061/012 FSCA 2008/11/26

SN0811123 Johnson and Johnson Lifescan One Touch Litra Test Strips (Part no 020-994-02) Z-0004-2009 Class II 2008/11/28

MHRA

MHRA

MHRA

MHRAJohnson & Johnson Medical

(HK)

Baxter COLLEAGUE Triple Channel Mono CX and CXE Volumetric Infusion Pumps (Product Codes: 2M8153K)

MHRA

MHRA

MHRA

MHRA

FDA

Sunquest Laboratory System (Software version: Sunquest Laboratory v5.4.2, v6.1, v6.2 and v6.3) FDA

Gabauer's Fluro-Ethyl Nonflammable Topical Anesthetic Skin Refrigerant (Aerosol Can) (P/N 0386-0020-20) FDA

MHRA

MHRA

MHRA

MHRA

MHRA

Health Canada

Health Canada

Health Canada

Health Canada

Health Canada

BHM Arjo Maxi 500 (KM560101, KM560104, KM560108, KM560181, KM560184, KM560188) Health Canada

MHRA

FDA


























SN0811124 Medtronic Physio-Control Lifepak 20 Defibrillator/monitor Z-2388-2008 Class II 2008/11/28

SN0811125 Terumo Advanced Perfusion System 1 (Model 801040 and 801041) Z-0309-2009 to Z-0310-2009 Class II 2008/11/28

SN0811126 Abbott CELL-DYN Sapphire Hematology Analyzer (List no 08H00-01, 08H00-03) Z-0306-2009 Class II 2008/11/28

SN0811127 Biomet Vanguard DCM Plus 16mm x 63/67mm Tibial Bearing (REF 183726) Z-0289-2009 Class II 2008/11/28

SN0811128 Zimmer Alumina Ceramic Femoral Head Z-0299-2009 to Z-0304-2009 Class II 2008/11/28

SN0811129 Stelkast Proven Cemented Semi-Constrained Total Knee (Part No. SC1591-38) Z-0308-2009 Class II 2008/11/28

SN0811130 Theken Spine Bone Marrow Aspiration Kit (Part no 50-20-001) Z-0272-2009 Class II 2008/11/28

FDAFDA

FDA

FDA

FDA

FDA

FDA









Local Agent

N/A N/A

Beckman Coulter Hong Kong Ltd N/A

N/A N/A

N/A N/A

N/A N/A

N/A N/A

N/A N/A

N/A N/A

N/A N/A

N/A N/A

Abbott Laboratories Ltd. 2593 2211



B Braun Medical Hong Kong 2277 6125

















Smith & Nephew Limited 2648 7700

N/A N/A

N/A N/A

N/A N/A


N/A N/A

N/A N/A

N/A N/A

N/A N/A

N/A N/A

N/A N/A

Cook Asia (Hong Kong) Ltd. 2781 0232

N/A N/A

N/A N/A



N/A N/A



N/A N/A

N/A N/A


N/A N/A


Maquet Hong Kong Ltd N/A

N/A N/A

N/A N/A

N/A N/A

N/A N/A

N/A N/A

Goodman Medical Supplies Ltd 2332 4455


S & V Sanford Instrument N/A


N/A N/A







N/A N/A


BD Asia Ltd (Hong Kong) 2575 8668

Ultronics Enterprises Ltd 2764 5208



N/A N/A

Gambro China Ltd N/A



N/A N/A

N/A N/A

N/A N/A

N/A N/A

N/A N/A

N/A N/A

N/A N/A

N/A N/A

N/A N/A

N/A N/A

N/A N/A

N/A N/A







Olympus Hong Kong and China Limited 2170 5678



N/A N/A

N/A N/A






N/A N/A

N/A N/A

N/A N/A


N/A N/A

N/A N/A

N/A N/A


N/A N/A



N/A N/A


Foxwood Medical Supplies 2770 6877




N/A N/A






N/A N/A


N/A N/A

N/A N/A


Monthly Summary of Medical Device Safety Alerts - October 2008*Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada


SN081001 Z-2380-2008 to Z-2383-2008 Class I 02-Oct-08

SN081002 Medtronic IsoMed Refill Kit (Model 8553) Z-1903-2008 Class II 02-Oct-08

SN081003 Stryker Osteonics Scorpio Total Knee Z-2079-2008 Class II 02-Oct-08

SN081004 Stryker Hoffman II compact Sterile Wrist Kit Z-2080-2008 Class II 02-Oct-08

SN081005 Stryker Universal Notch Preparation Guide amd X-Celerate Universal Block Pegless Z-1690-2008 to Z-1691-2008 Class II 02-Oct-08

SN081006 GE Healthcare Definium 8000 Digital Radiographic System Z-1822-2008 Class II 02-Oct-08

SN081007 GE Healthcare Definium 8000 Digital Radiographic System Z-1882-2008 Class II 02-Oct-08

SN081008 GE Definium 8000 (model 5135678) and GE Precision 500D (model 2403790-3) Z-1476-2008 to Z-1477-2008 Class II 02-Oct-08

SN081009 GE OEC 9600 C-arm Fluoroscopy System Z-1709-2008 Class II 02-Oct-08

SN081010 Z-2210-2008 to Z-2211-2008 Class II 02-Oct-08

SN081011 Siemens Radiation Therapy Systems Z-2095-2008 to Z-2104-2008 Class II 02-Oct-08

SN081012 Siemens Ultrasound Transducer 17L5HD Z-2230-2008 Class II 02-Oct-08

SN081013 Accuray CyberKnife Ronotic Radiosurgery System radiation therapy device Z-2056-2008 Class II 02-Oct-08

SN081014 Varian VariSource CT/MR Ring & Tandem Applicator Set Z-2081-2008 Class II 02-Oct-08

SN081015 Smith & Nephew TRIGEN Hind Foot Fusion Nail Z-2082-2008 to Z-2088-2008 Class II 02-Oct-08

SN081016 Merit Medical Arnot-Ogden Med Ctr Hip Pack (REF: K12T-02160A and K12T-02159A) Z-1808-2008 to Z-1809-2008 Class II 02-Oct-08

SN081017 Naviscan PEM Flex Solo II PET Scanner Z-2229-2008 Class II 02-Oct-08

SN081018 Biogenex Laboratories Xmatrx FISH Automated Staining System Z-1471-2008 Class II 02-Oct-08

SN081019 Abbott Total Bilirubin 2008/009/018/601/005 FSCA 02-Oct-08

SN081020 Immucor Galileo Echo 2008/009/022/061/013 FSCA 02-Oct-08

SN081021 ConMed VCareR Uterine Manipulators 2008/009/002/061/001 FSCA 02-Oct-08


Medtronic INDURA 1P Intrathecal Catheter (Model 8709SC), Intrathecal Catheter (Model 8731SC), Sutureless Pump Connector Revision Kit (Model 8678) and Intrathecal Catheter Pump Segment Revision Kit (Model 8596SC)

FDA

FDA FDA

FDA

FDA

FDA

FDA

FDA

FDA

GE 1.5T and 3.0 T Signa HDx MR System and GE Signa Excite 1.5T MR System, GE Signa Excite 3.0T MR System FDA

FDA

FDA

FDA

FDA

FDA

FDA

FDA

FDA

MHRA

MHRA

MHRA























SN081022 Sendal 3101-TJ Transfusion Set 2008/009/011/061/010 FSCA 02-Oct-08

SN081023 Diagnostica Stago (STA) Neoplastine CI (Plus) 10 2008/009/025/061/010 FSCA 02-Oct-08

SN081024 Spacelabs Ultraview Digital Telemetry Reciever, model 90478 2008/008/014/061/012 FSCA 02-Oct-08

SN081025 ThermoFisher Tryptone soya broth BO0351G 2008/009/023/601/003 FSCA 02-Oct-08

SN081026 Nebion, LLC HLX-8 Magnetic Resonance Device N/A Class I 06-Oct-08

SN081027 Kimal K-Flow access catheters 2008/008/026/401/004 FSCA 06-Oct-08

SN081028 Draeger Zeus Anaesthetic machines software version 4.01 2008/009/015/051/009 FSCA 06-Oct-08

SN081029 GENICON 5 mm Pyramidal Trocars 2008/009/026/061/009 FSCA 06-Oct-08

SN081030 GE Healthcare Aisys Anaesthesia machine 2008/009/025/061/011 FSCA 06-Oct-08

SN081031 Remploy Access and Accent attendant propelled wheelchairs MDA/2008/070 MDA 08-Oct-08

SN081032 Park House Alternating air mattress pumps models PHP198,396, 398 and 399 MDA/2008/071 MDA 08-Oct-08

SN081033 Hoggi BINGO Rehab Pushchair 2008/005/030/061/019 FSCA 08-Oct-08

SN081034 Sunrise Medical Breezy Moonlite Wheelchairs 2008/005/028/401/006 FSCA 08-Oct-08

SN081035 Hologic: ATEC 1212-20 Handpieces 2008/009/026/061/014 FSCA 09-Oct-08

SN081036 ThermoFisher Columbia Blood Agar, PB0122A 2008/010/002/601/002 FSCA 09-Oct-08

SN081037 Siemens Medical Solutions Diagnostics ADVIA Chemistry Controls 1 and 2 2008/010/001/061/008 FSCA 09-Oct-08

SN081038 Abbott ClearStar model number M771 2008/010/001/061/012 FSCA 09-Oct-08

SN081039 Baxter FLOGARD 6201 Volumetric Infusion Pump (Product Code 2M8063) Baxter Healthcare Ltd N/A Firm Initiated Field Action 10-Oct-08

SN081040 NeoMedix Trabectome I/A Console, Model Number 550014, surgical aspirator Z-0071-2008 Class II 13-Oct-08

SN081041 GE Healthcare OEC 9900 mobile fluoroscopic x-ray system Z-0368-2008 Class II 13-Oct-08


SN081043 ev3" 55442-2920, sterile EO, single Use, Visi-Pro Balloon-Expandable Peripheral Z-1547-2008 Class II 13-Oct-08

SN081044 Puritan-Bennett 800 Series Ventilator Backup Power Source (BPS) Model 802 Z-1692-2008 Class II 13-Oct-08


SN081046 Z-1751-2008 Class II 13-Oct-08

MHRA

MHRA

MHRA

MHRA

FDA

MHRA

MHRA

MHRA

MHRA

MHRA

MHRA

MHRA

MHRA

MHRA

MHRA

MHRA

MHRA

FDA

FDA

GE Healthcare Innova 3100 and 4100 Digital Fluoroscopic Imaging System with Bolus Chasing FDA

FDA

FDA

Toshiba America Medical Systems (TAMS) Aquilion 32 CT and 64 CT system, computed tomography x-ray system FDA

Siemens Medical Solutions, syngo Dynamics 6.0 Workplace; Picture archiving and communication system FDA


























SN081047 Siemens Medical Solutions, Mevatron Digital Linear Accelerator Z-1753-2008 to Z-1763-2008 Class II 13-Oct-08

SN081048 X-STOP Interspinous Process Decompression (lPD) System Z-1765-2008 Class II 13-Oct-08

SN081049 Z-2183-2008 Class II 13-Oct-08

SN081050 Cook Vital Port Vascular Access System Polysulfone Petite Z-2190-2008 to Z-2191-2008 Class II 13-Oct-08

SN081051 Brainlab VectorVision (VV) Sky Navigation Platform Z-2209-2008 Class II 13-Oct-08

SN081052 Biomet OSS (Orthopedic Salvage System) RS Non-Modular Long Tibial Base Z-2213-2008 to Z-2214-2008 Class II 13-Oct-08

SN081053 Applied Medical Silhouette Xtraflo Device with SL-6 Hydrophilic Coating Z-2219-2008 to Z-2224-2008 Class II 13-Oct-08

SN081054 Z-2235-2008 Class II 13-Oct-08

SN081055 Abaxis, Inc.Piccolo Chemistry Analyzer software version 6.121 Z-2286-2008 to Z-2287-2008 Class II 13-Oct-08

SN081056 Z-2307-2008 Class II 13-Oct-08

SN081057 Varian Medical Systems Eclipse device, model H48, Version 6.5 Z-2308-2008 Class II 13-Oct-08

SN081058 SCC Soft Computer SoftPath GUI Release Software Versions 3.17 and 4.1 Z-2329-2008 Class II 13-Oct-08

SN081059 Kyphon KyphX Osteo Introducer System with blunt tip introducer stylet Z-2347-2008 Class II 13-Oct-08

SN081060 Steris Small Renaissance Eagle 3000 Z-2350-2008 Class II 13-Oct-08

SN081061 Boston Scientific Platinum Plus Guidewire Z-2362-2008 to Z-2365-2008 Class II 13-Oct-08

SN081062 BD Ace Heat Therapy Z-2431-2008 Class II 13-Oct-08

SN081063 Zimmer Universal Optical Tracker Fixation, not sterile, REF 111.031 Z-2445-2008 Class II 13-Oct-08


SN081065 Siemens SOMATOM Emotion 6 and Emotion 16 Computed tomography X-ray system Z-2452-2008 to Z-2453-2008 Class II 13-Oct-08

SN081066 ConMed Linvatec Surgical Video Cart, Catalogue Number: VP8500 Z-2458-2008 Class II 13-Oct-08

SN081067 Z-2461-2008 Class II 13-Oct-08

SN081068 SCC SoftPath ASCII Software Releases 1.2, 2.1, 2.2 and 2.3 Z-2463-2008 Class II 13-Oct-08

SN081069 BD Anaesthesia Kits and Epidural Filter 2008/010/006/061/006 FSCA 14-Oct-08

SN081070 GE Healthcare Advantage Workstation Suite-Card IQ 2008/010/006/061/010 FSCA 14-Oct-08

SN081071 GE Healthcare AMX Series Mobile RAD System(AMX 4 and AMX 4+ 2008/010/002/061/004 FSCA 14-Oct-08

SN081072 Thomas Medical Products SafetSheath family 2008/009/029/061/018 FSCA 14-Oct-08

FDA FDA

GE Centricity AW Suite software version 2.0 and 2.0.1 with Card IQ Xpress Pro or Plus Module; for diagnostic image analysis FDA

FDA

FDA

FDA

FDA

Philips and Neusoft NeuViz Dual series computed Tomography Scanner System, X-Ray System FDA

FDA

Philips and Neusoft NeuViz Dual series computed Tomography Scanner System, X-Ray System FDA

FDA

FDA

FDA

FDA

FDA

FDA

FDA

Smith & Nephew Caption Disposable Platelet Concentrator Kit Ref 71178200 and Ref 71178202 FDA

FDA

FDA

American Medical 700 CX MS Pump IZ, Preconnect Penoscrotal, 18 cm, Sterile EO, REF 72404232 FDA

FDA

MHRA

MHRA

MHRA

MHRA




























SN081073 ThermoFisher Xpect Giardia/ Cryptosporidium Kit 2008/008/014/061/008 FSCA 14-Oct-08

SN081074 CASMED 500cc Single Patient Use Infusion Cuffs 2008/010/001/061/001 FSCA 14-Oct-08

SN081075 Boston Scientific Atlantis PV 15 MHz Imaging Catheter N/A Firm Initiated Field Action 15-Oct-08

SN081076 Boston Scientific Excelsior SL-10 Microcatheter N/A Firm Initiated Field Action 15-Oct-08

SN081077 Medtronic (Physio-Control) LIFEPAK CR Plus defibrillator/ LIFEPAK EXPRESS defibrillator Medtronic International Ltd N/A Firm Initiated Field Action 15-Oct-08


SN081079 Portland Orthopaedics Margron DTC Hip Replacement System Z-1931-2008 to Z-2001-2008 Class II 16-Oct-08


SN081081 ArthroCare ArthroWand Covator with Integrated Cable Wand (Catalog no AC4340-01) Z-2309-2008 Class II 16-Oct-08

SN081082 Spacelabs Medical Temperature Probe Adaptor PN-700-0031-00 Z-2314-2008 Class II 16-Oct-08

SN081083 Propper short gas-chex EO sterilization indicators (Recorder no 269001) Z-2330-2008 Class II 16-Oct-08

SN081084 Oscor Permanent Pacing Lead Z-2333-2008 Class II 16-Oct-08


SN081086 Nova Biomedical Varta Easypack XL Lithium Polymer Batteries (P/N 41772 and 42215) Z-1472-2008 Class II 16-Oct-08

SN081087 Stryker Rejuvenate Broach Z-2349-2008 Class II 16-Oct-08

SN081088 Stryker 6.5 Cancellous Bone Screw 25mm (Catalog No 2030-6525-1) Z-2007-2008 Class II 16-Oct-08

SN081089 AMO WaveScan WaveFront System Version 3.90/3.901 (Part No. 0070-1478) Z-2310-2008 Class II 16-Oct-08

SN081090 Abbott Flexiflo Quantum Pump Set (List # 50604) Z-2305-2008 Class II 16-Oct-08

SN081091 Siemens Acuson CV70 Ultrasound Systems Z-2212-2008 Class II 16-Oct-08

SN081092 Medtronic SPECIFY 3998 Lead Kit for Spinal Cord Stimulation (SCS) Z-2241-2008 Class II 16-Oct-08


SN081094 GE Precision RXi Digital remote X-Ray Imaging R&F System (model 5117828) Z-2145-2008 Class II 16-Oct-08

SN081095 GE Definium 800 Digital Radiographic System (Model 5135678) Z-1883-2008 Class II 16-Oct-08

SN081096 GE Datex-Ohmeda Engstrom Carestation Z-1829-2008 Class II 16-Oct-08

SN081097 GE Proteus XR/a Eclipse Collimator (Model # 2379827) Z-1713-2008 Class II 16-Oct-08

SN081098 GE Precision 500D and Advantx Legacy Radiographic and Fluoroscopic systems Z-1610-2008 to Z-1611-2008 Class II 16-Oct-08

MHRA

MHRABoston Scientific Hong Kong

LtdBoston Scientific Hong Kong

Ltd

Acumed Locking Tarsometatarsal Plate, Locking Proximal Metatarsal Wedge Plate, Locking Clavicle Plate FDA

FDA

Curlin Medical Model 2000, 4000 and 600 CMS/ Plus Ambulatory Infusion Pump, PainSmart, PainSmart IOD Ambulatory Infusion System FDA

FDA

FDA

FDA

FDA

Smiths Medical Deltec 3000 Large Volume Infusion Pump and Deltec Micro 3100 Large Volume Infusion Pump FDA

FDA

FDA

FDA

FDA

FDAFDAFDA

GE Innova 3100/3100IQ, 2100IQ, 4100/4100IQ, Advantx-E, Innova 2121-1Q/2121-1Q and Innova 2000 FDA

FDA

FDA

FDA

FDA

FDA

























SN081099 GE Innova 3100 Digital Fluoroscopic Imaging and Innova 4100 Digital Fluoroscopic Imaging Z-1521-2008 to Z-1522-2008 Class II 16-Oct-08

SN0810100 GE OEC 9800 Fluoroscopic X-Ray System and OEC 9900 Elite Fluoroscopic X-Ray System Z-1885-2008 Class II 16-Oct-08

SN0810101 2008/010/007/061/010 FSCA 17-Oct-08

SN0810102 Spacelabs Healthcare 90496 and 91496 Command Module NIBP Option 2008/010/003/061/005 FSCA 17-Oct-08

SN0810103 2008/010/009/061/005 FSCA 17-Oct-08

SN0810104 Varian C-Series Clinac Linear Accelerator 44028 Type I 17-Oct-08

SN0810105 Varian Acuity, Ximatron 43747 Type I 17-Oct-08

SN0810106 Immucor Galileo / Capture-R Ready test wells 43677 Type I 17-Oct-08

SN0810107 Immucor Galileo Echo / CaptureR Ready Scrn strip 43678 Type I 17-Oct-08

SN0810108 Ferno 35-A Mobile Transporter 43920 Type II 17-Oct-08

SN0810109 Anspach effort A) 12.6mm Boring Tool, B) 9.5mm Boring Tool 43458 Type II 17-Oct-08

SN0810110 Cardinal Health Custom Sterile Procedure Pack 43591 Type II 17-Oct-08

SN0810111 Sirona Dental System GMBH Galileos 3D X-Ray with Galaxis 1.5 43380 Type II 17-Oct-08

SN0810112 Siemen Axiom Artis, Axiom Artis DMP 43745 Type II 17-Oct-08

SN0810113 Roche Cobas Integra System-Smphetamines, Roche Hitachi-Online Amphetamines 43716 Type II 17-Oct-08

SN0810114 Welch Allyn Fiber Optic Sigmoidoscope, Insufflation Bulbs 43629 Type II 17-Oct-08

SN0810115 Cybernius Medical Nepfrocare Software 43736 Type II 17-Oct-08

SN0810116 Biomerieux Oberva Data Management System 42986 Type II 17-Oct-08

SN0810117 Stryker Communication Ophit DVI Extender 43879 Type II 17-Oct-08

SN0810118 Immco Diagnostic West Nile Virus IGG Indirect Elisa 43722 Type II 17-Oct-08

SN0810119 Griener Bio One Vacuette Lithium Heparin Blood Collection Tube 43583 Type II 17-Oct-08

SN0810120 N/A Firm Initiated Field Action 21-Oct-08

SN0810121 ThermoFisher EB0212E, Cooked meat medium, lot number 1048169 2008/010/007/601/002 FSCA 23-Oct-08

SN0810122 Qualigen Fast Pack Total PSA Lot 0807002 2008/010/010/061/004 FSCA 23-Oct-08

SN0810123 Orasure Oral Fluid Positive Control, Oral Fluid Negative Control, Oral Fluid Cutoff Calibrator 2008/010/010/061/006 FSCA 23-Oct-08

SN0810124 Radiometer ABL700 Series Calibration 1 Solution 2008/009/008/061/002 FSCA 23-Oct-08

SN0810125 Nucletron Oncentra Prostate System (with option CT/MRI imaging) 2008/006/027/401/003 FSCA 23-Oct-08

SN0810126 BD Vacutainer Blood Collection Tubes 2008/009/006/601/001 FSCA 23-Oct-08

FDA

FDA

Siemens Dimension Clinical Chemistry System - Enzymatic Creatinine Flex Reagent Cartridge DF270 MHRA

MHRA

Johnson & Johnson Biosense Webster NAVISTAR RMT 4mm, 8nn DS and THERMOCOOL Catheters MHRA

Health CanadaHealth CanadaHealth CanadaHealth CanadaHealth CanadaHealth CanadaHealth CanadaHealth CanadaHealth Canada

Health Canada

Health Canada

Health Canada

Health Canada

Health Canada


Bausch & Lomb Medalist Toric (SofLens 66 Toric) Contact Lenses (Lot no. W64067390, W64067389, W64067246) and Medalist One Day Plus, SofLens daily disposable (hilaflcon B) Visibility Tinted Contact Lenses (Lot no X10050809A and R10050805A)

Bausch & Lomb (Hong Kong) Limited

MHRA

MHRA

MHRA

MHRA

MHRA

MHRA






http://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/_list/rec-ret_md-im_date_july-sept_2008-eng.php























SN0810127 Homecraft Rolyan 2” and 4” Savanah raised toilet seats MDA/2008/075 MDA 24-Oct-08

SN0810128 Lomax Mobility Kid Active folding manual wheelchair with swing away footrests MDA/2008/076 MDA 24-Oct-08

SN0810129 Boston Scientific TruPath Biopsy Device and easy Core Biopsy Device N/A Firm Initiated Field Action 24-Oct-08

SN0810130 Boston Scientfic easyCore Biopsy System (Endoscopy) N/A Firm Initiated Field Action 24-Oct-08

SN0810131 Steris Quick Connect component (p/n 201048) Z-2462-2008 Class II 27-Oct-08

SN0810132 Philips Ultraview Digital Telemetry Transmitter (Model 91341-09) Z-2336-2008 Class II 27-Oct-08

SN0810133 Zimmer Quicklock Tracker (Size 2, Ref 111.100) Z-2444-2008 Class II 27-Oct-08

SN0810134 Sunrise Medical Quickie Groove Power Wheelchair with Transit option Z-2339-2008 Class II 27-Oct-08

SN0810135 Biomet Exact Calcar Planer Rasp Style Blade (REF 31-473795 to 31-473798) Z-2370-2008 to Z-2373-2008 Class II 27-Oct-08

SN0810136 Cardinal Health NicoletOne photic adapter cable 085-463700 Z-2389-2008 Class II 27-Oct-08


SN0810138 Arjo Kwiktrak Gate System Z-2434-2008 Class II 27-Oct-08


SN0810140 ACIST BRACCO AT P54 AngioTouch Kit Z-2406-2008 Class II 27-Oct-08

SN0810141 Beckman Coulter Synchron Acetaminophen (ACTM) Reagent (Part No. 472169) Z-2405-2008 Class II 27-Oct-08

SN0810142 Cardinal Health NicoletOne 5.30.2 Software Z-2459-2008 Class II 27-Oct-08

SN0810143 Boston Scientific easy Core Biopsy Device (Peripheral Interventions) N/A Firm Initiated Field Action 27-Oct-08

SN0810144 Baylis Medical BMC RF Cannula - Part # PMF20-100-10CS; Lot PFFA211107 2008/010/002/061/003 FSCA 27-Oct-08

SN0810145 GE Healthcare Giraffe and Panda Warmers 2008/010/014/601/001 FSCA 27-Oct-08

SN0810146 Medtronic OptiVol CareAlert and CareLink Transmissions Issue 2008/010/016/061/016 FSCA 27-Oct-08

SN0810147 Invacare Typhoon 1 & 2 Power Wheelchairs 2008/008/018/301/001 FSCA 27-Oct-08

SN0810148 Thoratec HeartMate II LVAS N/A Press Release 27-Oct-08

SN0810149 Helena Laboratories Manual D-dimer 5250 2008/010/010/061/012 FSCA 28-Oct-08

SN0810150 Metrax Primedic DefiMonitor XD Series 2008/010/006/061/011 FSCA 29-Oct-08

SN0810151 Tryton Side Branch Stent 2008/010/014/061/023 FSCA 29-Oct-08

SN0810152 Inverness Panbio West Nile Virus IgM Capture ELISA 2008/010/022/061/008 FSCA 29-Oct-08

SN0810153 Biomet 2.00mm Crimp Sleeve, item: 350805, lot 568400 2008/010/013/601/004 FSCA 29-Oct-08

SN0810154 Edwards Lifesciences Vigilance II Monitor VIG2/VIG2E 2008/010/010/061/011 FSCA 29-Oct-08

SN0810155 Stryker Circlip retaining system 2008/010/009/061/007 FSCA 29-Oct-08

SN0810156 Stryker System 6 and Cordless Driver 3 Handpiece 2008/010/015/061/013 FSCA 29-Oct-08

SN0810157 Respironics BIPAP Focus Ventilator System 2008/010/009/061/028 FSCA 29-Oct-08

SN0810158 Siemens IMMULITE® 2000/2500 Substrate Module L2SUBM 252 2008/010/023/061/015 FSCA 29-Oct-08

MHRA

MHRA



FDA

FDAFDAFDA

FDA

FDA

Angiodynamics Centros Chronic Hemodialysi Curved Catheter Set (Catalog no./REF 10303101 to 10303103) FDA

FDAB. Braun Horizon Pump Set, Adult Metriset, Safeline Metriset, Metriset Burette Set, Burette Set, Add-On Burette Set FDA

FDA

FDA

FDABoston Scientific Hong Kong

Ltd

MHRA

MHRAMHRAMHRAFDA

MHRAMHRAMHRAMHRAMHRAMHRAMHRAMHRAMHRAMHRA



















http://www.fda.gov/oc/po/firmrecalls/thoratec10_08.html












SN0810159 2008/009/026/601/002 FSCA 30-Oct-08

SN0810160 BRAHMS PAPP-A Kryptor Lots 566034 and 566036 2008/010/010/061/007 FSCA 30-Oct-08

SN0810161 Ergolet Luna Track Hoist Handset 2008/004/004/401/002 FSCA 30-Oct-08

SN0810162 Sidhil Universal Standard and High Siderails 2008/008/018/401/004 FSCA 30-Oct-08

SN0810163 R82 X-Panda size 2 High-Low Frame 2008/004/025/401/012 FSCA 30-Oct-08

SN0810164 Spacelabs Healthcare Ultraview SL Command Module (Model 90496 and 91496) Z-2342-2008 to Z-2343-2008 Class II 30-Oct-08

SN0810165 Zimmer Durom cup, Metasul Durom acetabular compenent Z-2415-2008 to Z-2426-2008 Class II 30-Oct-08

SN0810166 Medtronic BI-700-00027 0-arm 1000 Imaging System mobile X-ray System Z-2034-2008 Class II 30-Oct-08

SN0810167 Siemens Sonoline G50/G60 Ultrasound System (Software versions 1.0.0 to 1.5.0b) Z-2468-2008 Class II 30-Oct-08

SN0810168 GE Precision MPi (Model 5126893 -, 2385125, 2398238) Z-2142-2008 to Z-2144-2008 Class II 30-Oct-08


DLS Medical Wound dressing pack avm3550, Woundcare pack avm3633, Basic care pack avm3757 MHRA

MHRAMHRAMHRAMHRA

FDA

FDA

FDA

FDA

FDAGE Healthcare Innova 2100IQ, 3100 IQ, 4100 IQ Digital Fluoroscopic Imaging System (Versatile cardiac and Vascular imaging system) FDA













Local Agent















Smith & Nephew Limited 2645 8703

N/A N/A

N/A N/A

N/A N/A


N/A N/A

N/A N/A



N/A N/A

Healthpro Technology Co. Ltd N/A

N/A N/A

N/A N/A

N/A N/A

N/A N/A

Draeger Medical Hong Kong Ltd. 2877 3077

N/A N/A


N/A N/A

N/A N/A

N/A N/A

N/A N/A

N/A N/A

N/A N/A




N/A N/A



N/A N/A

COVIDEN 3157 7220

Sanko Medical Systems (HK) Ltd. 2384 0688




N/A N/A



N/A N/A

N/A N/A


N/A N/A



N/A N/A

N/A N/A

N/A N/A


N/A N/A


Smith & Nephew Limited2645 8703


N/A N/A

N/A N/A

N/A N/A




N/A N/A

BrainLAB Ltd. (Hong Kong)


N/A N/A

N/A N/A




N/A N/A

N/A N/A

N/A N/A

ArthoCare Asia Pacific 2159 7436

N/A N/A

N/A N/A

N/A N/A

N/A N/A

N/A N/A

















N/A N/A


Varian Medical Systems Pacific Inc. 27242836

Varian Medical Systems Pacific Inc. 27242836

N/A N/A

N/A N/A


N/A N/A

N/A N/A

N/A N/A




N/A N/A

Biomerieux China Ltd (HK) 2356 7033


N/A N/A

Mekim Ltd 2774 8300


N/A N/A

N/A N/A

N/A N/A

N/A N/A

N/A N/A

BD Asia Ltd (Hong Kong)


N/A N/A

N/A N/A



Swedish Trading Co., Ltd


Zimmer PTE Ltd. (Hong Kong branch) 2992 0968N/A N/A

N/A N/A

Cardinal Health

N/A N/A



Pacific Medical (Hong Kong) Ltd. 2343 8009


Cardinal Health


N/A N/A



N/A N/A

N/A N/A

N/A N/A

N/A N/A

N/A N/A

N/A N/A

N/A N/A

N/A N/A



CELKI Medical Company



N/A N/A

N/A N/A

N/A N/A

N/A N/A

N/A N/A

N/A N/A







Monthly Summary of Medical Device Safety Alerts - September 2008*Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada


SN080901 Invacare Reliant 100 / 150 / 200 / 250 2008/001/008/401/008 FSCA 2008/09/02

SN080902 Sybron Pitt Easy implants 2008/008/019/061/013 FSCA 2008/09/02

SN080903 Liftech Gemini Ceiling Track Hoist 2008/006/011/291/006 FSCA 2008/09/02

SN080904 Boston Scientific Platinum PlusT Guidewire (Peripheral) N/A Firm Initiated Field Action 2008/09/03

SN080905 Medtronic Adjustable Valve Model 6248VAL and Attain 6216A and 6218A System Kits Medtronic International Ltd N/A Firm Initiated Field Action 2008/09/03

SN080906 Physio Control LIFEPAK CR Plus Medtronic International Ltd N/A Firm Initiated Field Action 2008/09/03

SN080907 Ev3 Primus GPS Biliary Stent Systems (Ref: BXB35-08-37-75) Z-2170-2008 Class II 2008/09/04

SN080908 Ev3 Protege GPS Biliary Stent Systems (Ref: SERB65-06-60-120) Z-2169-2008 Class II 2008/09/04

SN080909 Arjo Nautica (GK) Mattress Stretcher Z-1234-2008 Class II 2008/09/04

SN080910 Smiths Medical CADD-MS"3 Ambulatory Infusion Pumps (Model 7400, Rx only) Z-1641-2008 Class II 2008/09/04

SN080911 Z-2160-2008 Class II 2008/09/04

SN080912 Stryker Stem Trial, Triathlon Revision Instruments Z-2157-2008 to Z-2158-2008 Class II 2008/09/04

SN080913 Stryker Xcelerate Patella System Reamer Shaft Assembly (Product no.: 8001-1702) Z-1778-2008 Class II 2008/09/04

SN080914 Medtronic Midas Rex Legend tapered dissecting tool (Model F2/8TA23) Z-2156-2008 Class II 2008/09/04

SN080915 Medtronic Physio Control, FASTPAK batteries Z-1567-2008 Class II 2008/09/04

SN080916 Z-2154-2008 Class II 2008/09/04

SN080917 GE Healthcare Precision RXi 23A/32A Remote X-Ray Imaging R&F System Z-1563-2008 to Z-1565-2008 Class II 2008/09/04

SN080918 Siemens Medical Syn go Imaging XS (Model no 7502029) Z-1643-2008 Class II 2008/09/04

SN080919 Hill-Rom Century+ Bed (Model P1400 HBSM siderail upgrade kits) Z-1777-2008 Class II 2008/09/04

SN080920 Bisco BISCEM Dual-Cured Self-Adhesive Resin Cement Z-1696-2008 to Z-1697-2008 Class II 2008/09/04

SN080921 Acumed 3.5mm x 32.5mm Cortical Screw used with the Polarus Humeral Fixation System Z-2155-2008 Class II 2008/09/04

SN080922 Z-2201-2008 Class II 2008/09/04

SN080923 Pride Mobility Q-Logic Controller Software Z-1776-2008 Class II 2008/09/04


MHRA

MHRAMHRA


FDA

FDA

FDA

FDA

Philips Medical General X-Ray System types with Digital Spot Imaging (DSI) software (Software version: rel 6) FDA

FDA

FDA

FDA

FDA

GE Healthcare Corometrics Model 250 series Maternal/ Fetal Monitor (Models 256 and 259, part no 2024489-002) FDA

FDA

FDA

FDA

FDA

FDA

Pacific Consolidated Industries Mobile Oxygen Storage Tank, MOST 20-2B (Part no 793080-002) FDA

FDA






















SN080924 Bostson Scientific Smash Balloon Dilatation Catheter N/A Firm Initiated Field Action 2008/09/05

SN080925 Genzyme Seprafilm Adhesion Barrier (Product Number: 4301-02 and 4301-05) Z-1647-2008 to Z-1648-2008 Class II 2008/09/08

SN080926 Z-1531-2008 to Z-1532-2008 Class II 2008/09/08

SN080927 Caire Generation 4 electronic liquid gauges Z-1716-2008 Class II 2008/09/08

SN080928 Huntleigh Healthcare Maxisky 600 2007/010/018/401/014 FSCA 2008/09/08

SN080929 Peacocks Medical Fitzyou Moulded Wheelchair seat Systems 2007/010/016/261/001 FSCA 2008/09/08

SN080930 Invacare Scanbed SB750 2007/011/015/061/004 FSCA 2008/09/08

SN080931 Abbott Universal Clamp Reduction Tool 2008/008/014/061/004 FSCA 2008/09/09

SN080932 GE Healthcare Signa HDx Scanner 2008/008/027/061/019 FSCA 2008/09/09

SN080933 Intersurgical Solus Laryngeal Mask Airway 2008/008/027/061/028 FSCA 2008/09/09

SN080934 Johnson and Johnson Cordis LuMend Outback Re-entry catheter 2008/008/021/061/008 FSCA 2008/09/09

SN080935 Bausch & Lomb AMVISC and AMVISC PLUS - Viscoelastic (Ref: DV-2007-8041) N/A Firm Initiated Field Action 2008/09/10

SN080936 Innovacon Prostate Specific Antigen 2008/008/029/061/022 FSCA 2008/09/10

SN080937 Drager Primus, Apollo, Pallas Devices 2008/008/029/061/020 FSCA 2008/09/10

SN080938 STERIS 20 Sterilant Concentrate 2008/007/015/401/008 FSCA 2008/09/10

SN080939 Gambro SteriChek Sensitive Total Chlorine Reagent Strips 2008/008/012/061/011 FSCA 2008/09/11

SN080940 Medtronic Neurostimulator programmers MDA/2008/065 MDA 2008/09/12

SN080941 Edwards Lifesciences Ascendra Balloon Catheter 2008/008/027/061/007 FSCA 2008/09/12

SN080942 Sirona type B, VS and S Siroclaves and Siromini 2008/009/002/061/004 FSCA 2008/09/12

SN080943 Boston Scientific ALTRUA® Implantable Pacemaker 2008/009/003/061/007 FSCA 2008/09/12

SN080944 GE Precision 500D Classical Radiographic-Fluoroscopic X-Ray System (Model# 2289299-2) Z-0369-2008 Class II 2008/09/12

SN080945 Z-1592-2008 to Z-1593-2008 Class II 2008/09/12

SN080946 Otsuka UBiT®-IR300 Infrared Spectrophotometer, software versions 7.0, 7.01 and 7.11 Z-1749-2008 Class II 2008/09/12

SN080947 Invivo Lithium Polymer Wireless Module Batteries Goodwin Health Care Ltd N/A Firm Initiated Field Action 2008/09/12

SN080948 Teleflex Weck Clips products : Hemolok clips, Horizon Clips and Hemoclip Solar-med Limited N/A Firm Initiated Field Action 2008/09/12

SN080949 Vital Signs Light Wand Orotracheal Lighted Stylet 2008/008/028/061/002 FSCA 2008/09/16

SN080950 Cook Zenith AAA Stent-Graft 2006/005/017/401/009 FSCA 2008/09/16


FDA

Sunrise Medical Quickie Rhythm Power Wheelchair with QC (non-expandable) electronics (Model no. EIPW10 and EIPW13) FDA

FDA

MHRA

MHRA

MHRA

MHRA

MHRA

MHRA

MHRA

Bausch & Lomb (Hong Kong) Limited

MHRA

MHRA

MHRA

MHRA

MHRA

MHRA

MHRA

MHRA

FDA

Abbott InCompass Spinal Fixation System T-Handle Driver and PathFinder Spinal Fixation System T-Handle Driver FDA

FDA

MHRAMHRA

























SN080951 Philips Healthcare iSite PACS 2008/008/026/061/019 FSCA 2008/09/16

SN080952 ThermoFisher BO0366D Brain Heart Infusion 2008/009/002/601/004 FSCA 2008/09/16

SN080953 R82 A/S Hip Belt 2008/009/005/061/006 FSCA 2008/09/16

SN080954 Philips Healthcare HDI4000 Diagnostic Ultrasound System 2008/009/010/061/004 FSCA 2008/09/16

SN080955 Philips Healthcare HD3 Diagnostic Ultrasound System 2008/009/010/061/010 FSCA 2008/09/16

SN080956 BD FACSAria Sorters running BD FACSDiva Software, version 3.0 or later BD Asia Ltd (Hong Kong) N/A Firm Initiated Field Action 2008/09/16

SN080957 Johnson and Johnson ASP Automatic Endoscope Reprocessor (AER) N/A Firm Initiated Field Action 2008/09/16

SN080958 Boston Scientific iLabR Ultrasound Imaging Systems N/A Firm Initiated Field Action 2008/09/17

SN080959 GE Healthcare Responder 2000 Defibrillator 2008/008/013/061/012 FSCA 2008/09/18

SN080960 Stryker Orthopaedics Kinemax Plus Revision TS Tibial Inserts MDA/2008/066 MDA 2008/09/19

SN080961 Philips Healthcare BV Pulsera and Endura 2008/009/010/061/008 FSCA 2008/09/19

SN080962 Z-2192-2008 to Z-2193-2008 Class II 2008/09/19

SN080963 Abbott Free Style Blood Glucose Monitoring System Test Strips Z-1813-2008 Class II 2008/09/19

SN080964 Abbott PathFinder Cannulated T-Handle Bone Awl (Part No. 1155-2) Z-1784-2008 Class II 2008/09/19

SN080965 Z-1526-2008 Class II 2008/09/19

SN080966 Z-1825-2008 Class II 2008/09/19

SN080967 Medtronic CD Horizon Agile Dynamic Stabilization Device Z-1408-2008 to Z-1441-2008 Class II 2008/09/19

SN080968 Medtronic Physio-Control LIFEPAK 20 and LIFEPAK 20e Difibrillator/monitor Z-2009-2008 to Z-2011-2008 Class II 2008/09/19

SN080969 Medtronic Suction Jar Lid for Medela Vario 18 Vacuum Pump Z-2168-2008 Class II 2008/09/19

SN080970 Z-2225-2008 Class II 2008/09/19

SN080971 Z-1768-2008 Class II 2008/09/19

SN080972 Z-2196-2008 Class II 2008/09/19

SN080973 Z-1814-2008 Class II 2008/09/19

SN080974 Z-1626-2008 to Z-1627-2008 Class II 2008/09/19

SN080975 Stryker Digital System Ultra (SDC Ultra) (Model no.: 240-050-988) Z-1316-2008 Class II 2008/09/19

SN080976 Covidien/Mallinckrodt CT9000/ CT9000ADV (Model no.: 241300) Z-1828-2008 Class II 2008/09/19

SN080977 Biomet EZLoc 7-8mm TM Femoral Fixation (Catalog No 904780) Z-1782-2008 Class II 2008/09/19

MHRA

MHRA

MHRA

MHRA

MHRA

Johnson & Johnson Medical Hong Kong


MHRA

MHRA

MHRAAbbott AGA Medical Corporation AMPLATZER Delivery System (REF 9-DEL-10F-45/80) and AMPLATZER Sizing Balloon II (REF 9-SB-24) FDA

FDA

FDAGE Datex-Ohmeda Neonatal Enhancement for the Engstrom Carestation (Model# 1505-3272-00) FDA

GE Centricity AW Suite 2.0 Software running on the Centricity RA 1000 or RA600/CA1000 Workstation FDA

FDA

FDA

FDAGE 1.5 T and 3.0 T Signa HDX MR System Model No. 2226300, 2377062-61, 2395001, 2395001-2, 5107849 and 5127452 FDA

Siemens Linear Medical Accelerators equipped with COHERENCE Therapist R2.1 and Primeview 3 i R 2.1 FDA

Siemens SIMIVIEW 3000, SIMVIEW NT and MEV ASIM S systems (Instructions" TH003/08/S" update) FDA

Stryker Scorpio Total Knee Posteriorly Stabilized Femoral Component #7R and #7l (Catalog # 71-4107R and 71-4506L) FDA

Stryker Gamma3 System Set Screwdriver, Flexible Shaft and Gammas Set Screwdriver Instrument Set, Orthopedic Device FDA

FDA

FDA

FDA


























SN080978 Z-1318-2008 Class II 2008/09/19

SN080979 Varian Medical Varis Aria Radiation Oncology Version 8.1 Z-2194-2008 Class II 2008/09/19

SN080980 Telefex Weck - DuraHook (Catalog #382800, 382805) Z-1856-2008 to Z-1857-2008 Class II 2008/09/19

SN080981 AGFA IMPAX 6.2.1 System (PAC) Z-1245-2008 Class II 2008/09/19

SN080982 AGFA IMPAX 4.1 and WEB1000 Versions 3.1 Z-1243-2008 to Z-1244-2008 Class II 2008/09/19

SN080983 Z-1893-2008 to Z-1894-2008 Class II 2008/09/19

SN080984 Z-1588-2008 to Z-1589-2008 Class II 2008/09/19

SN080985 Allez Spine Laguna Pedicle Screw System (IT-FN1001 and IT-FN1007) Z-1819-2008 to Z-1820-2008 Class II 2008/09/19

SN080986 Galil Medical Warming Catheter Z-1698-2008 Class II 2008/09/19

SN080987 Resonance Technology Headset Model no RTC-2K and RTC-551-070 Z-1823-2008 to Z-1824-2008 Class II 2008/09/19

SN080988 BD Asia Ltd (Hong Kong) N/A Firm Initiated Field Action 2008/09/22

SN080989 MIM 4.0 and MIM 4.1 Z-1827-2008 Class II 2008/09/22

SN080990 Merit Medical Systems Fluid Administration Set, Custom Kit Z-1800-2008 to Z-1807-2008 Class II 2008/09/22

SN080991 Z-1790-2008 to Z-1799-2008 Class II 2008/09/22

SN080992 Encore Medical Keramos Replacement Polyethlene Liner Z-1785-2008 Class II 2008/09/22

SN080993 Orthodocs Cocoon 2008/006/006/401/006 FSCA 2008/09/24

SN080994 Pride Mobility Quantum Vibe Power Chair 2008/005/014/301/003 FSCA 2008/09/24

SN080995 Philips BV Pulsera and Endura, C-arm 2008/009/011/061/008 FSCA 2008/09/24

SN080996 Beckman Coulter Access Immunoassay Systems HAV Ab Reagent Kit 2008/009/011/601/601/002 FSCA 2008/09/24

SN080997 Tyco Healthcare Hot/Cold Pack N/A N/A 2008/09/24

SN080998 Various Hot/Cold Gel Pack N/A N/A 2008/09/25

SN080999 GE 1.5T and 3.0T Sigma HDx System and GE Signa Excite 1.5T MR and 3.0T MR System Z-1890-2008 to Z-1891-2008 Class II 2008/09/26

SN081000 Z-1886-2008 Class II 2008/09/26

SN081001 Philips OmniDiagnost Eleva X-Ray System Z-1374-2008 Class II 2008/09/26

SN081002 Hitachi Altaire MRI System Emergency Rundown Switch Unit (ERDU) Z-1542-2008 Class II 2008/09/26

SN081003 Stryker OmniFit X-Ray Templates and OmniFit HFx Sell Sheets Z-2054-2008 to Z-2055-2008 Class II 2008/09/26

SN081004 Stryker Triathlon Femoral Sizer Z-1864-2008 Class II 2008/09/26

Biomet Orthopedics Echo Hip Instrumentation Exact Slotted Stem Inserter (Part number 31-555610) FDA

FDAFDAFDA

FDA

Baxter Healthcare (Edwards Lifesciences LLC) Fem-Flex II Femoral Venous Cannula and Fem-Flex II Duraflo Treated Femoral Venous Catheter FDA

Bio-Rad VARIANT β-thalassemia Short Program Hemoglobin Testing System(Model 270-0019 and 270-0002) FDA

FDA

FDA

FDA

BD Vacutainer 16 x 100 MM Serum Blood Collection tubes, BD Vacutainer 16 x 100 mm SSTII Advance Blood Collection tubes, BD Vacutainer 16 x 100 Glass Calcium Chloride Blood Collection tubes (FA 08002)

FDAFDA

Mentor Psi-Tec Tubing, Autofuse Tubing, i-Vac Tubing, Lamis Tubing Set, Y Tubing Set, Irrigation Tubing, Psi-Tec SYRINGE Pump Infiltration Tubing, Contour Genesis Infiltration Tubing, Contour Geneses Inf/IR Tubing AND Contour Genesis Aspiration Tubing

FDA

FDAMHRAMHRAMHRAMHRATGA

TGA

FDA

Philips Gallileo Automatic Collimator (Part Number 9896 010 00612, 9896 010 00614, 9896 010 00615) FDA

FDA

FDA

FDA FDA



















http://tga.gov.au/alerts/devices/gelpacks2.htm

http://tga.gov.au/alerts/devices/gelpacks2.htm








SN081005 Stryker Short Barrel Sideplate (Catalog no. 3362-0-404) Z-2865-2008 Class II 2008/09/26

SN081006 Z-1866-2008 to Z-1867-2008 Class II 2008/09/26

SN081007 Zimmer 4.5 Compression plate-broad (REF 4945-10-01) Z-2179-2008 Class II 2008/09/26

SN081008 Medtronic Physio-Control Internal Defibrillator Handles and Internal Defibrillation Electrodes Z-2035-2008 to Z-2036-2008 Class II 2008/09/26

SN081009 Medtronic VNUS Medical U-CLIP Remocal Tool (UREM 1860) Z-1609-2008 Class II 2008/09/26

SN081010 Johnson and Johnson Depuy LCS Knee Z-1812-2008 Class II 2008/09/26

SN081011 Merit Fountain Indusion System, 4F (REF IS4-90-50) Z-2107-2008 Class II 2008/09/26

SN081012 I-Flow On-Q C-bloc 400ml (REF CB005) Z-2133-2008 Class II 2008/09/26

SN081013 I-Flow ON-Q PainBuster Infusion Pump (REF PS6504, Part No. 5001260) Z-1869-2008 Class II 2008/09/26

SN081014 Intuitive Surgical da Vinvi S Surgical System (Model no IS2000) Z-2204-2008 Class II 2008/09/26

SN081015 Z-1811-2008 Class II 2008/09/26

SN081016 Z-1887-2008 to Z-1889-2008 Class II 2008/09/26

SN081017 Integra LifeSciences PANTA Nails Z-1877-2008 Class II 2008/09/26

SN081018 Accuracy Cyberknife Robotic Radiosurgery System Z-1862-2008 Class II 2008/09/26

SN081019 GMP LS-232 Large 12 LeadWear Single Pack and LS-202 Large LeadWear Combo Pack Z-1659-2008 to Z-1660-2008 Class II 2008/09/26

SN081020 Diamedix Is-anti-Gliadin IgG Enzyme Immunoassay Test kit (Catalog no 720-800) Z-1684-2008 Class II 2008/09/26

SN081021 Cardiac Science Electrode Adaptor Cable Quick-Combo System (Model 9055) Z-1714-2008 Class II 2008/09/26

SN081022 Z-1873-2008 to Z-1875-2008 Class II 2008/09/26

SN081023 Greiner Bio-One Vacuette, Plastic Cannula HOLDEX (Ref 450216) Z-2134-2008 Class II 2008/09/26

SN081024 Z-2205-2008 to Z-2208-2008 Class II 2008/09/26

SN081025 Philips Brilliance CT Big Bore System-Main Unit and Brilliance CT System (16P) 43308 Type II 2008/09/29

SN081026 Philips Diagnost 94, Diagnost 96 and Diagnost 97 43340 Type II 2008/09/29

SN081027 Philips Brilliance 64 Slice CT System-Main Unit 43322 Type II 2008/09/29

SN081028 Philips Essenta DR 43360 Type II 2008/09/29

SN081029 Philips Isite Pacs 43324 Type II 2008/09/29

SN081030 Philips HDI 4000 System 43395 Type II 2008/09/29

SN081031 43314 Type II 2008/09/29

SN081032 Siemens Axiom Luminos TF 43288 Type II 2008/09/29

FDA Stryker Ureteral Kit (Model no.: 220-180-516) and Stryker Ureteral Universal Kit (Model no.: 220-180-517) FDA

FDA

FDA

FDA

FDA

FDA

FDA

FDA

FDA Intuitive Surgical DA Vinci Surgical System Model S Cardiac Probe Gasper Instrument (Model IS2000) FDA

Cooper Surgical M-Style Mushroom Cup Vacuum Assisted Delivery System, M-Style Cup with UVR and Mystic II M-Style Mushroom Cup Vacuum Assisted Delivery System FDA

FDA

FDA

FDA

FDA

FDA

Sun Biomedical VisuaLine Single Dip Oxycodone, VisuaLine Propoxyphene test system, VisuaLine Tricyclic Antidepressants FDA

FDA ICU Medical Hospira Intralock Lipid Compatible 3-Way Stopcock, Hospira Monitoring Kit (PA Line) and Left Heart Kit FDA

Health Canada

Health CanadaHealth CanadaHealth CanadaHealth CanadaHealth Canada

Siemens Angiostar; Multistar D, P; Bicor HS, HS-ACS; Coroskop HS, HS-ACS, HI-P, C and Neurostar Top Health Canada

Health Canada






























SN081033 GE Instatrak 3500 System 42398 Type II 2008/09/29

SN081034 Impac Medical Systems Sequencer (Model 40000-000000-RO) 43446 Type II 2008/09/29

SN081035 Zimmer Patient Helper Reinforced Overhead Bar 43273 Type II 2008/09/29

SN081036 Porex Surgical Ocular Conformers (Non-Vented and Vented) 43459 Type II 2008/09/29

SN081037 Medilab Beautytek Premium Edition 41783 Type II 2008/09/29

SN081038 Home Telehealth WebVMC Remote Nurse 2008/008/018/061/010 FSCA 2008/09/29

SN081039 Covidien Argyle Suction Catheter 2008/007/029/061/011 FSCA 2008/09/29

SN081040 Bauerfeind AG Shin Tubes Mod. A3-Ti200/400 and A3-St200 2007/009/018/401/005 FSCA 2008/09/29

SN081041 B Braun Microspeed Uni Mobile stand GA411 2008/009/022/061/003 FSCA 2008/09/29

SN081042 Coloplast Folysil Xtra Silicone Indwelling Catheters 2008/008/028/401/010 FSCA 2008/09/29

SN081043 Utah Intran Plus IUPC trays 2008/009/016/051/001 FSCA 2008/09/30

SN081044 Siemens Medical Solutions Diagnostics Advia 120 & Advia 2120 2008/006/005/291/004 FSCA 2008/09/30

SN081045 Draeger Sub-Acute Care Ventilator Carina 2008/007/003/401/011 FSCA 2008/09/30

SN081046 BD Visitec High Viscosity Injector 2008/009/022/061/010 FSCA 2008/09/30

SN081047 Johnson and Johnson Animas™ 2020 and IR 1200 Insulin Pump 2008/009/022/061/015 FSCA 2008/09/30

SN081048 Sybron Endo K3 Engine File G-Pack 43337 Type II 2008/09/30

SN081049 Adac Laboratories Precedence System (6 and 16 Slice) 43306 Type II 2008/09/30

SN081050 Apogee Intermittent Catheter 43335 Type II 2008/09/30

SN081051 Medacta AMIS Universal Table for Leg Positioner (Model no. 01.15.10.0172) Z-1870-2008 Class II 2008/09/30

SN081052 EBI Trauma Fixation Systems Z-2012-2008 Class II 2008/09/30

SN081053 Biomet Hybrid Glenoid Boss Cutter; item 406150 Z-1658-2008 Class II 2008/09/30

SN081054 Biomet OSS Interlok IM Stem Z-1879-2008 to Z-1881-2008 Class II 2008/09/30

SN081055 Boston Scientific Precision Charger 1.0 (UPN M365SC53000) N/A Firm Initiated Field Action 2008/09/30

Health CanadaHealth CanadaHealth CanadaHealth CanadaHealth Canada

MHRAMHRAMHRAMHRAMHRAMHRAMHRAMHRAMHRAMHRA


FDA

FDAFDAFDA

























Local Agent

N/A N/A

N/A N/A

N/A N/A

Boston Scientific HK Limited 2960 7136



N/A N/A

N/A N/A










Siemens Ltd. 2810 7533

N/A N/A

N/A N/A

N/A N/A

N/A N/A

N/A N/A




Genzyme Asia Limited 2810 1613

N/A N/A

N/A N/A

N/A N/A

N/A N/A

N/A N/A


GE Medical Systems HK Ltd 2783 1838

N/A N/A



N/A N/A


Swedish Trading Co. Ltd. N/A

Gambro Hong Kong Limited N/A


N/A N/A

N/A N/A


GE Healthcare 2609 9233


Otsuka Pharmaceutical (HK) Ltd 2881 6299

Goodwin Health Care Ltd N/A

Solar-med Limited 2425 0926

N/A N/A

Cook Asia Ltd N/A


2821 5480

N/A N/A

N/A N/A

2821 5480

2821 5480




GE Medical Systems HK Ltd 2783 1838

Stryker China Limited 2518 6988
















COVIDIEN 3157 7220

N/A N/A

Philips Healthcare - Great China




N/A N/A

Varian Medical Systems Pacific Inc. 2724 2836Solar-med Limited 2425 0926




Bio-Rad Pacific Ltd. 2789 3300

N/A N/A

N/A N/A

N/A N/A


N/A N/A

N/A N/A

N/A N/A

N/A N/A

N/A N/A

N/A N/A



COVIDIEN 3157 7220

N/A N/A




N/A N/A










N/A N/A

N/A N/A

N/A N/A

N/A N/A

N/A N/A

N/A N/A

N/A N/A


N/A N/A

N/A N/A

N/A N/A

N/A N/A

Mekim Ltd 2774 8300

N/A N/A











N/A N/A

Zimmer PTE Ltd. (Hong Kong branch) 2992 0968N/A N/A

N/A N/A

N/A N/A

Covidien 2574 3251

N/A N/A

B Braun Medical Hong Kong N/A

N/A

N/A N/A

2810 7533

N/A N/A



N/A N/A

N/A N/A

N/A N/A

N/A N/A

N/A N/A

N/A N/A

N/A N/A


Coloplast (Hong Kong) Ltd

Siemens Ltd


Monthly Summary of Medical Device Safety Alerts - August 2008*Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada


SN080801 Bayer Ascensia Contour blood glucose meters MDA/2008/059 MDA 2008/08/01

SN080802 Levitronix CentriMag Systems 2008/002/026/401/001 FSCA 2008/08/01

SN080803 Stryker Scorpio Series 7000 Tibial Impactor/Extractor 2008/007/007/061/017 FSCA 2008/08/01

SN080804 ThermoFisher Scientific BO0348V Maximum recovery diluent 2008/007/018/601/501 FSCA 2008/08/01

SN080805 Baxter FLOSEAL Endoscopic Applicator (#1500181) Baxter Healthcare Ltd N/A Firm Initiated Field Action 2008/08/04

SN080806 Arjo Carendo multi-purpose hygiene chair MDA/2008/060 MDA 2008/08/05

SN080807 CASMED 740 Series Multiparameter Monitor 2008/007/022/061/001 FSCA 2008/08/05

SN080808 Siemens ADVIA Centaur CP immunoassay system MDA/2008/061 MDA 2008/08/05

SN080809 TomoTherapyR Hi-Art Treatment System 2008/004/024/061/020 FSCA 2008/08/05

SN080810 TomoTherapyR Hi-Art Treatment System 2008/004/024/061/021 FSCA 2008/08/05

SN080811 GE Healthcare Centricity Perinatal (formerly QS) System - PFILS software Z-2037-2008 Class II 2008/08/07

SN080812 Z-0274-2008 Class II 2008/08/07

SN080813 Z-1348-2008 Class II 2008/08/07

SN080814 Z-2138-2008 Class II 2008/08/07

SN080815 Varian Acuity with Conebeam COMPUTED Tomography (Model No. H77) Z-1460-2008 Class II 2008/08/07

SN080816 Varian High-Definition 120 MultiLeaf Collimator (Product code: H56) Z-1459-2008 Class II 2008/08/07

SN080817 Philips 1.5T Intera and 1.5T Achieva systems 2008/007/022/051/005 FSCA 2008/08/08

SN080818 Biomet Pectus Table Top Bender (part # 01-3906) 2008/001/018/291/026 FSCA 2008/08/11

SN080819 Johnson and Johnson Depu Delta XTEND 2008/007/023/061/004 FSCA 2008/08/11

SN080820 Baxter COLLEAGUE Triple Channel Mono and CXE Volumetric Infusion Pumps 2008/007/022/051/006 FSCA 2008/08/13

SN080821 Stille Sonesta 6210 fluoroscopy procedure table MDA/2008/063 MDA 2008/08/13

SN080822 ThermoFisher EB0212E Cooked meat medium 2008/007/021/601/503 FSCA 2008/08/13

SN080823 Regulatory Insight Rolling Walkers (Rollators) 42905 Type II 2008/08/13


MHRAMHRAMHRA

MHRA

MHRA

MHRA

MHRA

MHRA

MHRA

FDA

GE Healthcare Precision 500D Classical R&F System with control room PC (Model no. 5117866-27) FDA

Intuitive Surgical Da Vinci S 8mm Instrument Cannula (Model IS2000, Part No. 400254-01, 400255-01) FDA

Synovis GEM 2753 Microvascular Anastomotic Coupler, 2.5mm (REF GEM2753/1, P/N 5111-00250-010) FDA

FDA

FDA

MHRA

MHRA

MHRA

MHRA

MHRA

MHRA

Health Canada
























SN080824 Maquet Servo-I (Model 640870800 E407E) 43009 Type II 2008/08/13

SN080825 42249 Type II 2008/08/13

SN080826 43205 Type II 2008/08/13

SN080827 Acist Angiographic System - Table Kit 43028 Type II 2008/08/13

SN080828 Brainlab AG Brainscan Treatment Planning Software 42381 Type II 2008/08/13

SN080829 43176 Type II 2008/08/13

SN080830 Philips Digital Diagnost 43190 Type II 2008/08/13

SN080831 Draeger Fabius Titro Anesthesia System 43160 Type II 2008/08/13

SN080832 Hospira LifeCare PCA Label Utilility, Version 1.0 CD Z-1181-2008 Class II 2008/08/14

SN080833 Z-1529-2008 Class II 2008/08/14

SN080834 3M Comply EO Chemical indicators Strips (Catalog # 1251) Z-1568-2008 Class II 2008/08/14

SN080835 Z-1368-2008 to Z-1369-2008 Class II 2008/08/14

SN080836 Siemens IMMULITE / IMMULITE 1000 Progesterone 2008/007/025/061/020 FSCA 2008/08/14

SN080837 Homecraft Rolyan Savanah Raised Toilet Seat Brackets 2008/003/006/401/011 FSCA 2008/08/14

SN080838 Stryker REDUCTION SPOON 09MM 2008/007/023/061/010 FSCA 2008/08/14

SN080839 Activate Patron Bohemia Strollers 2006/010/011/081/003 FSCA 2008/08/14

SN080840 Sunrise Medical Lomax Kid Active Recliner Attendant Push Wheelchairs 2008/001/003/061/022 FSCA 2008/08/15

SN080841 Apline Microtargeting Electrode Cable Apline BioMed N/A Firm Initiated Field Action 2008/08/15

SN080842 Varian Exact Couch Pinch Point N/A Firm Initiated Field Action 2008/08/15

SN080843 GE Healthcare Solar 8000/i/M 2008/007/024/601/510 FSCA 2008/08/18

SN080844 Ortho Europe Uniaxial Foot 2008/002/026/061/008 FSCA 2008/08/18

SN080845 Philips MRI Magnet Venting System Inspection 2008/007/023/061/006 FSCA 2008/08/18

SN080846 ConMed Frazier and Poole Suction Instruments 2008/007/015/061/018 FSCA 2008/08/18

SN080847 Medi-Plinth Three function electric foot switches 2008/005/008/401/005 FSCA 2008/08/18

SN080848 Siemens Magnetom Mobile Systems 2008/007/031/061/014 FSCA 2008/08/19

SN080849 KCI 500 ml Canister for Infovac 2008/007/031/061/003 FSCA 2008/08/19

Health Canada

Teleflex Medical A) Dermahook Neuro Elastic Retractors 1/2", B) Dermahook Neuro Elastic Retractors 1/4" Health Canada

Hologic A) Delphi Bone Densitometer, B) Discovery QDR Bone Denositometer, C) Explorer QDR Bone Densitometer, D) QDR 4500 Bone Densitometer Health Canada

Health Canada

Health Canada

Philips A) PCR AC-500/PCR-5000, B) PCR Corado Eleva, C)PCR Compano System / PCR Eleva S Plus Health Canada

Health Canada

Health Canada

FDA

Beckman Coulter Cytomics FC 500 Flow Cytometry System with Data Innovations Instrument Manager (Part no 626553 and 6605628) FDA

FDA

Johnson and Johnson Medical Advanced Sterilization Products EvoTech Endoscope Cleaner & Reprocessor (Product Code 50004 AND 50004-002) FDA

MHRA

MHRA

MHRA

MHRA

MHRA


MHRA

MHRA



























SN080850 Lomax Mobility Wheelchairs 2006/007/019/081/009 FSCA 2008/08/19

SN080851 Medtronic MaximoR II Device 2008/007/021/401/014 FSCA 2008/08/19

SN080852 Roche Diagnostics modular analytics 2008/007/011/061/012 FSCA 2008/08/20

SN080853 Edwards Lifescience Accusol 35 Harmofialysis solutions for Acute Renal Therapy N/A N/A 2008/08/20

SN080854 Chiron PROCLEIX (Assay Reagent) Press N/A N/A 2008/08/21

SN080855 ArthroCare Topaz XL ArthroWand 2008/008/001/061/001 FSCA 2008/08/21

SN080856 MedtronicLIFEPAK CR Plus and LIFEPAK Express Defibrillator 2008/008/004/051/010 FSCA 2008/08/21

SN080857 Smiths Medical CADD-MS 3 Ambulatory Infusion Pimp (Model 7400) Z-1621-2008 Class II 2008/08/21

SN080858 Philips Medical Systems iSite PACS version 3.6.28.0 and version 4.1.17.0 Z-1443-2008 to Z-1444-2008 Class II 2008/08/21

SN080859 Z-1442-2008 Class II 2008/08/21

SN080860 Z-1525-2008 Class II 2008/08/21

SN080861 BD Difco(tm) Shigella Antiserum Poly Group B (Catalog no. 228351 and 210722) Z-1527-2008 to Z-1528-2008 Class II 2008/08/21

SN080862 Z-1830-2008 to Z-1853-2008 Class II 2008/08/21

SN080863 Z-1526-2008 Class II 2008/08/21

SN080864 Z-1515-2008 Class II 2008/08/21

SN080865 Medtronic PROSTIVAR RF Model 8929 Hand Piece 2008/008/006/061/010 FSCA 2008/08/25

SN080866 BrainlabVectorVision Sky and/or BrainSUITE NET system 2008/008/004/051/009 FSCA 2008/08/25

SN080867 Varian Exact Couch with Exact Couch Top 2008/008/007/061/015 FSCA 2008/08/25

SN080868 Maquet Expiratory Valve Coils 2008/007/016/061/004 FSCA 2008/08/25

SN080869 GE Healthcare CT/SPECT Studies of Brain Scans 2008/008/011/051/011 FSCA 2008/08/25

SN080870 Altomed Irrigating handpiece A3404 2008/008/005/051/002 FSCA 2008/08/25

SN080871 B Braun Prevision Implant System 2008/008/004/061/010 FSCA 2008/08/25

SN080872 GE Healthcare CT/SPECT Studies of Brain Scans 2008/008/011/051/011 FSCA 2008/08/25SN080873 Cook Endoureterotomy Stent Set 2008/007/021/061/001 FSCA 2008/08/25

SN080874 Apex TS 1211/1311 Combo Unit 41710 Type II 2008/08/27

SN080875 Impac Medical Systems SEQUENCER (Model: 50200-000000-RO) 33877 Type I 2008/08/27

SN080876 Dentsply Osteograf N-300 (Model: 930000-304) 41213 Type II 2008/08/27

SN080877 Dentsply Lexicon size 15 dental hand files 40992 Type II 2008/08/27

SN080878 Synthes Labelling for Synthes Power Drive (Model: 530.1) 43294 Type II 2008/08/27

SN080879 BD BBL Staphyoside Test (Model: 240952, 240953) 41510 Type II 2008/08/27

SN080880 Tyco Argyle Suction Catheter (Model: 1180-851121, 1180-851147) 43260 Type II 2008/08/27

MHRAMHRA

MHRA

Health Canada

MHRAMHRA

FDA

FDA

Varian Medical Systems On-Board Imager, versions 1.0.15 and 1.2.05 Imaging Accessory to Medical Linear Accelerator FDA

BD FACSDiva Software Versions 4.0.1 to 5.0.2 Flow Cytometry Acquistion & Analysis software (Catalog no 641609) FDA

FDA

Atrium Medical HydraGlide Heparin coated PVC Straight Thoracic Catheters with Tapered Connector Tip FDA

GE Datex-Ohmeda Neonatal Enhancement for the Engstrom Carestation (Model# 1505-3272-00) FDA

Impac Medical Systems SEQUENCER, MOSAIQ versions 1.3 and 1.4 (Model # 40003-001000-RO) FDA

MHRA

MHRAMHRA

MHRA


Health CanadaHealth CanadaHealth CanadaHealth CanadaHealth CanadaHealth CanadaHealth Canada
































SN080881 43276 Type II 2008/08/27

SN080882 43296 Type II 2008/08/27

SN080883 2008/008/013/061/009 FSCA 2008/08/27

SN080884 Johnson and Johnson Vicryl Rapide 2008/008/011/061/007 FSCA 2008/08/27

SN080885 Medtronic Deep Brain Stimulator lead kit with cap 2008/008/015/061/004 FSCA 2008/08/27

SN080886 Molnlycke ProcedurePak 2008/007/023/061/008 FSCA 2008/08/27

SN080887 Beckman Coulter Access Power Supply Assembly Seld (Part No.: A48196/6845C) Z-1183-2008 Class II 2008/08/28

SN080888 Z-1513-2008 to Z-1514-2008 Class II 2008/08/28

SN080889 Abbott CELL-DYN Sapphire Hematology Analyzer (List No. 08H00-01) Z-2139-2008 Class II 2008/08/28

SN080890 Z-1694-2008 Class II 2008/08/28

SN080891 Stryker Omnifit EON Surgical Protocol Z-1750-2008 Class II 2008/08/28

SN080892 Stryker Radius Rod Persuader and Radius Capsin (Catalog # 486619190, 486619210) Z-1377-2008 to Z-1378-2008 Class II 2008/08/28

SN080893 Siemens Medical charged-particle radiation therapy system Z-1769-2008 Class II 2008/08/28

SN080894 Biomet Modular Microplasty Cup Inserter and Impactor Z-1185-2008 to Z-1187-2008 Class II 2008/08/28

SN080895 Bio-Rad MONOLISA Anti-HBc EIA (Catalog no 26186) Z-1189-2008 Class II 2008/08/28

SN080896 GIVEN Diagnostic System with PillCam SB Capsule Z-1447-2008 Class II 2008/08/28

SN080897 AMO Excimer Laser System Z-1695-2008 Class II 2008/08/28

SN080898 Medline Bariatric Wheelchair Z-1770-2008 to Z-1772-2008 Class II 2008/08/28

SN080899 EKOS EndoWave Infusion System Z-1773-2008 Class II 2008/08/28

SN080900 Acumed Osteo-Clage Cable System Package Assembly (01-0001-S) Z-2140-2008 Class II 2008/08/28

SN080901 StatSampler 200 uL, Li Heparin (Ref: SS2H) Z-2234-2008 Class II 2008/08/28

SN080902 Philips HeartStart MRx Monitor/Defibrillator 2008/008/018/061/026 FSCA 2008/08/28

SN080903 Smith & Nephew Dyonics 25 Tubeset kits 2008/008/015/061/007 FSCA 2008/08/28

SN080904 Siemens Trugene HIV-1 Module for GuideLines Rules 11.0, 12.0 & 13.0 2008/008/018/061/021 FSCA 2008/08/28

SN080905 Sorin D901 Lilliput 1/ D100 Dideco Kids 2008/008/020/061/006 FSCA 2008/08/28

SN080906 Medtronic Disposable Magellan Kits and One Source Kits 2008/008/021/061/010 FSCA 2008/08/28

SN080907 Baxter HOMECHOICE/HOMECHOICE PRO Automated Peritoneal Dialysis System 2008/005/028/061/023 FSCA 2008/08/29

SN080908 Leckey Squiggles Stander on Pivot Chassis 2008/005/008/401/003 FSCA 2008/08/29

SN080909 Philips Allura Xper FD10 and FD10/10 2008/007/002/061/011 FSCA 2008/08/29

Philips Allura XPER FD10, Allura XPER FD 20 system, Allura XPER FD 20/10 System, Integris Allura, Integris H5000F Cardiology Imaging System Health Canada

Philips Achieva 1.5T MRI System - Sense Torso Coil, Intera 1.5T MRI System - Sense XL Torso Coil Health Canada

Siemens MicroScanR Dried Overnight Gram Negative and Synergies plusR Negative Panels MHRA

MHRAMHRAMHRA

FDA

Boston Scientific VITALITY DR+ ICD (model 1872) and VITALITY EL (models T127, T167, T177) ICD FDA

FDAMallinckrodt OptiVantage DH Injection System (Catalog# V8400, Part no. 241078 & Catalog# V8402, Part # 241079) FDA

FDA

FDA

FDAFDAFDAFDAFDA

FDAFDAFDAFDA

MHRA

MHRA

MHRA

MHRA

MHRA

MHRA

MHRAMHRA































SN080910 2008/005/019/601/350 FSCA 2008/08/29

SN080911 BrainlabExac TRac Infrared Tracking Platform 5.0, 5.5 2008/008/011/061/001 FSCA 2008/08/29

SN080912 Baylis Medical Toronto Transseptal Catheter Model TSC-50-75 2008/008/021/061/001 FSCA 2008/08/29

GE Voluson E8 Ultrasound Systems MHRA

MHRAMHRA





Local Agent

Bayer Healthcare 2814 4836

N/A N/A


N/A N/A


N/A N/A

N/A N/A

N/A N/A

N/A N/A

N/A N/A



N/A N/A

N/A N/A



Philips Medical System 2876 7525

N/A N/A

Johnson & Johnson Medical Hong Kong 2738 2818

N/A N/A

N/A N/A

N/A N/A

N/A N/A




N/A N/A

N/A N/A

Pacific Medical (Hong Kong) Ltd. 2343 8009

N/A N/A




Hospira Ltd 2285 8382


3M Hong Kong Ltd 2806 6314



N/A N/A


N/A N/A

N/A N/A

N/A N/A



N/A N/A


N/A N/A

N/A N/A


N/A N/A


N/A N/A

Medtronic International Limited 2919 1300

Roche Diagnotics (Hong Kong) Ltd. 2485 7510


Chiron Limited 2161 3104

N/A N/A



Philips Medical Systems 2821 5480




N/A N/A


N/A N/A


BrainLAB Ltd. (Hong Kong)




N/A N/A

B Braun Medical Hong Kong N/A

GE Medical Systems HK Ltd 2783 1838Cook Asia Ltd. N/A

N/A N/A

N/A N/A

N/A N/A

N/A N/A

N/A N/A







Johnson & Johnson Medical (HK) 2738 2818Medtronic International Limited 2919 1300

N/A N/A




Covidien 2574 3251




N/A N/A

Bio-Rad Pacific Ltd. 2789 3300N/A N/A


N/A N/A

N/A N/A

N/A N/A

N/A N/A


N/A N/A

Siemens Limited 2810 7533

N/A N/A



N/A N/A




BrainLAB Ltd. (Hong Kong) N/A

N/A N/A


Monthly Summary of Medical Device Safety Alerts - July 2008*Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada


SN080701 Invacare Action³ manual wheelchair MDA/2008/044 MDA 2008/07/02

SN080702 Abbott Diagnostics ARCHITECT c8000 System 2008/006/002/601/380 FSCA 2008/07/02

SN080703 Anspach Sterile Single-use Cuting Burrs 2008/006/011/291/004 FSCA 2008/07/02

SN080704 Arrow International Cannon catheter , Cannon catheter II and Edge catheter 2008/006/018/061/010 FSCA 2008/07/02

SN080705 TerumoTubing packs for extracorporeal circulation of blood 2008/005/021/401/005 FSCA 2008/07/02

SN080706 2008/006/018/601/425 FSCA 2008/07/02

SN080707 Handicare B.V. Beatle / Puma power wheelchairs 2008/001/007/301/001 FSCA 2008/07/02

SN080708 Biomet UK Lactosorb L Template 2008/005/021/061/017 FSCA 2008/07/02

SN080709 Stryker Reflex Revision Screwdriver 2008/006/012/291/005 FSCA 2008/07/02

SN080710 BioLytical Laboratories INSTI HIV-1 /HIV-2 antibody test 2008/006/011/401/013 FSCA 2008/07/02

SN080711 Sunrise Medical Groove Power Wheelchairs 2008/003/003/261/001 FSCA 2008/07/03

SN080712 Medtronic Sutureless Connector Intrathecal Catheters 2008/006/025/061/013 FSCA 2008/07/03

SN080713 Remploy Access & Accent wheelchair 2007/010/023/261/001 FSCA 2008/07/03

SN080714 Beckman Coulter Access Ultra sensitive Insulin Assay Kit (Part Number 33410) Z-1160-2008 Class II 2008/07/03

SN080715 Stryker Solar HA Humeral Stem with Plasma Coating 7mm to 17mm Z-1236-2008 Class II 2008/07/03

SN080716 AGFA HeartLabCardiovascular DICOMstore (Model # L9M8E) Z-1241-2008 Class II 2008/07/03

SN080717 Z-1242-2008 Class II 2008/07/03

SN080718 AGFA IMPAX 6.2.1 Network Gateway Server, License Key (Catalog # ABC) Z-1306-2008 Class II 2008/07/03

SN080719 Boston Scientific Lumenis/Slimline Fiber Strippers N/A Firm Initiated Field Action 2008/07/03

SN080720 Z-1188-2008 Class II 2008/07/03

SN080721 Medline IL Latex-Free Breathing Bags,; Reservoir Bags Z-1162-2008 to Z-1164-2008 Class II 2008/07/03

SN080722 Huntleigh Healthcare BabyCare crib trolleys MDA/2008/048 MDA 2008/07/03

SN080723 Smiths Medical Graseby Omnifuse and Omnifuse PCA syringe MDA/2008/049 MDA 2008/07/03

SN080724 Alcon Hong Kong Ltd N/A Firm Initiated Field Action 2008/07/07

SN080725 Park House Healthcare PHP 198, PHP396, PHP398 & PHP399 Pumps 2008/001/010/401/007 FSCA 2008/07/07

SN080726 Draeger Medical Intensive Care ventilators 2008/006/025/181/011 FSCA 2008/07/07


MHRAMHRAMHRA

MHRA

MHRABioMerieux Agars 43001, 43041, and 43401 MHRA

MHRA

MHRA

MHRA

MHRA

MHRA

MHRA

MHRA

FDA

FDA

FDA

AGFA HeartLab Cardiovascular Results Management Product (Model No.: L58RZ and L9MWQ) FDA

FDA


Kentec Medical Reusable Ohmeda Compatible Finger Clip Sensor (Model Number: E403-02, Product code: PS2225) FDA

FDA

MHRA

MHRAAlcon MONARCH II IOL Delivery System - Cartridge Model B ( Pat # 8065977758; Lot#: 174244, 174250)

MHRA

MHRA


























SN080727 TherapostureTheracare Beds supplied with Mesh Linked Padded Rails 2007/009/027/401/001 FSCA 2008/07/07

SN080728 Medtronic SynchroMed® II Implantable Infusion Pump 2008/005/029/291/001 FSCA 2008/07/07

SN080729 Liko AB Universal SlingBar 2008/006/024/071/002 FSCA 2008/07/07

SN080730 Invacare Harrier Heavy Duty (HD) battery powered wheelchair MDA/2008/050 MDA 2008/07/08

SN080731 Quest 88 Kaye Posture Control Walkers 2007/011/015/401/003 FSCA 2008/07/08

SN080732 Steris Quick Connect (Model QXCXXXX) 38366 Type II 2008/07/10

SN080733 39224 Type II 2008/07/10

SN080734 Siemens Oncor Expression (Model 7360717, 8139839) 39313 Type II 2008/07/10

SN080735 Siemens AG Somatom Definition (Model 7741445) 39782 Type II 2008/07/10

SN080736 GE Healthcare Precision RX/I Remote Imaging System (Model 5117828) 40889 Type II 2008/07/10

SN080737 Trinity Biotech D-Dimer High Control 41341 Type II 2008/07/10

SN080738 Cordis Smart Control Nitinol Stent System (Model C10040SL) 41441 Type II 2008/07/10

SN080739 Siemens AG Magicview 300 (Model VA60A) 41521 Type II 2008/07/10

SN080740 Siemens Mevasim-S, Simview 3000, Simview NT 41532 Type II 2008/07/10

SN080741 Siemens Dimension Automated LDL Calibrator (Model DC131) 41796 Type II 2008/07/10

SN080742 42037 Type II 2008/07/10

SN080743 Nonin Model PalmSAT handheld pluse Oximeter 42163 Type II 2008/07/10

SN080744 Philips Collimators 989601000612, 989601000614, 989601000615 42275 Type II 2008/07/10

SN080745 Siemens Advia 120, 2120, 42277 Type II 2008/07/10

SN080746 Roche Myoglobin Control Set 42325 Type II 2008/07/10

SN080747 AGFA Drystar AXYS 42393 Type II 2008/07/10

SN080748 Elekta Precise Treatment Table 42401 Type II 2008/07/10

SN080749 Computerized Medical Systems Monaco 42691 Type II 2008/07/10

SN080750 Edwards LifeStent FlexStar Biliary Stent System Z-1246-2008 to Z-1296-2008 Class II 2008/07/10

SN080751 AGFA Impax 4.5, 5.1, 5.2 ans 5.2x Picture Archiving System (PACs) Z-1307-2008 Class II 2008/07/10

SN080752 Stryker Peek Electrosurgical Handle 34279 Type II 2008/07/11

SN080753 GE OEC Medical Systems Aspirators (Model 1006236-001) 36242 Type II 2008/07/11

SN080754 Siemens Coherence Oncologist (Model 7351898) 42716 Type II 2008/07/11

SN080755 Balder Battery powered wheelchairs 2008/004/003/301/001 FSCA 2008/07/11

SN080756 Siemens Mevatron Primus, Mevatron MX-2, Oncor Expression, Oncor Impression IMRT Plus 42781 Type II 2008/07/11

SN080757 Lomax Mobility Kid Active Folding Frame with Swing Away Footrests 2007/012/006/061/004 FSCA 2008/07/14

MHRA

MHRA

MHRA

MHRAMHRA

Health CanadaCardinal Health A) Sterile Line Pack, B) Sterile Primary Spinal Pack, C) Sterile Cardiovascular Universal Health Canada


Health Canada

Health Canada

Health Canada

Health Canada


Walter Lorenz Surgical 4MM Stella Osteotomes (Model 01-0575), 6MM Stella Osteotomes (Model 01-0576) Health Canada

Health Canada

Health Canada

Health Canada

Health Canada

Health Canada


FDAFDA

Health Canada


MHRA

Health Canada

MHRA

































SN080758 Electric Mobility Scooters 2007/008/002/301/003 FSCA 2008/07/14

SN080759 Q'Straint Wheelchair tie-downs 2008/004/003/301/003 FSCA 2008/07/14

SN080760 Edwards Lifesciences Fogarty Fortis™ Catheter 2008/006/030/061/018 FSCA 2008/07/14

SN080761 Philips Medical Systems Allura Xper and Integris Systems 2008/007/001/061/020 FSCA 2008/07/14

SN080762 Becton Dickinson BD™ Saline Syringers 2008/006/030/061/002 FSCA 2008/07/14

SN080763 Gyrus ACMI Dual Lumen Catheter 2008/006/027/601/455 FSCA 2008/07/14

SN080764 GE Healthcare vascular systems 2008/007/001/061/014 FSCA 2008/07/14

SN080765 Sorin Biomedica Cardio Freedom Solo Biological Heart Valve 2008/007/009/061/010 FSCA 2008/07/14

SN080766 Zimmer NexGen® Complete Knee Solution 2008/007/002/061/012 FSCA 2008/07/14

SN080767 Boston Scientific Platinum PlusT Cononary Guidwire 2008/007/001/061/022 FSCA 2008/07/14

SN080768 Dade Behring StratusR CS Acute Care? Troponin I TestPaks 2008/007/002/061/014 FSCA 2008/07/16

SN080769 Abbott ARCHITECT Total β-HCG calibrator 2008/006/015/601/416 FSCA 2008/07/16

SN080770 ArthroCare Covator Arthro Wand 2008/004/016/401/009 FSCA 2008/07/16

SN080771 Philips Medical Systems Biopsy Guide Starter Kits 2008/007/003/061/008 FSCA 2008/07/17

SN080772 BD Vacutainer Blood Collection Tubes Containing Heparin BD N/A Firm Initiated Field Action 2008/07/21

SN080773 Respironics PLV100 Ventilator (#RCA200802) CELKI Medical Company N/A Firm Initiated Field Action 2008/07/21

SN080774 Kimal safety fistula needle MDA/2008/051 MDA 2008/07/22

SN080775 Handicare Puma and Beatle battery powered wheelchairs MDA/2008/052 MDA 2008/07/22SN080776 Nucletron SPOT Pro v3.0 2008/007/003/061/009 FSCA 2008/07/22

SN080777 Unomedical OP suction tubing MDA/2008/053 MDA 2008/07/24

SN080778 Smiths Medical Portex™ Blue Line Ultra tracheostomy kits MDA/2008/054 MDA 2008/07/24

SN080779 Philips Healthcare HeartStart OnSite automated external defibrillators (AEDs) 2008/007/003/061/012 FSCA 2008/07/24

SN080780 Dade Behring ADVIA Chemistry Systems 2008/007/002/061/013 FSCA 2008/07/24

SN080781 Abbott Molecular m2000sp Instrument 2008/007/003/601/464 FSCA 2008/07/24

SN080782 Beckman Coulter GEN.S and LH SlideMakers 2008/007/002/601/459 FSCA 2008/07/24

SN080783 Roche cobas b 221 Software version 7.0 2008/007/007/061/008 FSCA 2008/07/24

SN080784 Applied Medical 15mm SeparatorR access systems 2008/007/008/061/006 FSCA 2008/07/24

SN080785 2008/006/018/601/424 FSCA 2008/07/24

SN080786 Q’Straint Wheelchair QLK-100 Docking System 2008/004/009/401/001 FSCA 2008/07/24

SN080787 Stryker Navigation Pin, Ortholock EX Pin, and Ortholock QLK-100 Docking System 2008/006/024/051/008 FSCA 2008/07/24

SN080788 Bayer 5 second Contour blood glucose monitoring system 2008/007/003/601/463 FSCA 2008/07/24

SN080789 DEAS Heated Wire Circuits 2008/005/014/401/002 FSCA 2008/07/24

MHRAMHRA

MHRA

MHRA

MHRA

MHRAMHRAMHRAMHRAMHRAMHRAMHRAMHRA

MHRA


MHRA


GE Healthcare Innova ® single plane cardiovascular X‐ray imaging systems MHRA

MHRA

MHRA

MHRA

MHRA
















http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/MedicalDeviceAlerts/CON020687
















SN080790 Ventana Benchmark and Discovery Series Instruments 2008/007/011/061/017 FSCA 2008/07/24

SN080791 Otto Bock HealthcareKimba Inline Twin Mobility Base Units 2006/003/014/401/005 FSCA 2008/07/24

SN080792 Sunrise Medical Rumba Power Wheelchairs 2007/009/020/291/012 FSCA 2008/07/24

SN080793 Orthodocs Cocoon 2008/006/006/401/006 FSCA 2008/07/24

SN080794 Carina VT Homecare, intensive care and transport ventilators MDA/2008/055 MDA 2008/07/25

SN080795 Siemens Healthcare Laboratory analysers MDA/2008/056 MDA 2008/07/25

SN080796 Sunrise Medical Mermaid, Ranger & Dipper Bathing Products 2007/012/004/061/013 FSCA 2008/07/25

SN080797 Agfa IMPAX Clients 6.x 2008/006/013/061/001 FSCA 2008/07/25

SN080798 BD 60ml Luer-Lok Syringe (Recorder no. 309653) BD N/A Firm Initiated Field Action 2008/07/28

SN080799 Abbott Sequoia Spinal System Surgical Kits Z-1479-2008 Class II 2008/07/28

SN080800 Medtronic Intrathecal Catheter Pump Segment Revision Kit (Model no 8596SC) Z-1308-2008 Class II 2008/07/28

SN080801 BHM Medical Infrared (IR) Hand Control System Z-1233-2008 Class II 2008/07/28

SN080802 AMS In-Fast Ultra Kit with Polypropylene Suture (Ref 72403885) Z-1235-2008 Class II 2008/07/28

SN080803 Z-1379-2008 to Z-1380-2008 Class II 2008/07/28

SN080804 Celsus Laboratories Heparin Lithium Lithium Lyophilized Z-1917-2008 Class II 2008/07/28

SN080805 Sunrise Medical Manual and Powered Wheelchairs 2007/003/006/401/005 FSCA 2008/07/28

SN080806 Abbott ARCHITECT AFP assay 2008/007/011/601/482 FSCA 2008/07/28

SN080807 Hill-Rom Affinity® Four Birthing Bed 2008/007/011/061/018 FSCA 2008/07/28

SN080808 Karomed COMM-METAL Supreme Profiling Bed 2008/003/031/401/003 FSCA 2008/07/28

SN080809 Technical Service Consultants Urine collection bottle MDA/2008/057 MDA 2008/07/29

SN080810 Aidservice Medi-Tec Classic hoist MDA/2008/058 MDA 2008/07/31

SN080811 Troponin I Rapid Test and Myoglobin/CK-MB/Troponin I Combo Test 2008/007/021/061/008 FSCA 2008/07/31

SN080812 Fresenius Injectomat 50ml syringe 2008/007/015/061/014 FSCA 2008/07/31

SN080813 Philips Axis and Irix Gamma Cameras 2008/007/014/061/004 FSCA 2008/07/31

SN080814 Beckman Coulter Acetaminophen Reagent 2008/007/024/601/509 FSCA 2008/07/31

SN080815 Stryker Triathlon TS Fermoral Trial Z-1572-2008 to Z-1587-2008 Class II 2008/07/31

SN080816 Z-2016-2008 to Z-2033-2008 Class II 2008/07/31

SN080817 Biomet Vanguard DCM CR Tibial Bearing Z-1375-2008 to Z-1376-2008 Class II 2008/07/31

SN080818 Medline Eudur02 Oxygen Concentrator with Oxygen Monitor Z-1473-2008 to Z-1474-2008 Class II 2008/07/31

SN080819 42936 Type II 2008/07/31

MHRA

MHRA

MHRAMHRAMHRAMHRAMHRAMHRA

FDA

FDA

FDAFDA

Smiths Medical FLO2 Emergency Non-rebreather High Flow O2 System and Oxy-PEEP High Flow O2 with PEEP FDA

FDA

MHRA

MHRA

MHRA

MHRA

MHRA

MHRA

MHRA

MHRA

MHRA

MHRAFDA

Beckman Coulter Cytomics FC 500 Flow Cytometry System with CXP Software version 2.1 and 2.2 FDA

FDA

FDA

Philips A)Brilliance 64 Slice CT System-Main Unit, B) Brilliance CT Computed Tomography System, Health Canada































SN080820 42569 Type II 2008/07/31

SN080821 Biomet Microfixation 1.5X5MM HT X-DR SCREW (Model 91-1505, 95-1505) 42390 Type II 2008/07/31

SN080822 GE Datex Ohmeda A) Giraffe Warmer M1118179, B) Panda Warmer M1110875 42766 Type II 2008/07/31

SN080823 Stryker Vertier Surgical Tables 43004 Type II 2008/07/31

SN080824 Gambro Bioline, Hermoline 42406 Type II 2008/07/31

SN080825 Stryker 3.5MM Super 90-S Serfas Suction Probe (Model 0279-351-300) 42939 Type II 2008/07/31

SN080826 GE OEC Secondary Collimator Filter On OEC 9600 (Model 2274014) 42974 Type II 2008/07/31

SN080827 Gambro Dasco SPA Phoenix Hemodialisis Delivery System (Model 6022933700) 42906 Type II 2008/07/31

SN080828 Philips A) Prism 1000S, B) Prism 1000XP, C) Prism 2000S, D) Prism 2000XP 32350 Type II 2008/07/31

SN080829 Maquet Cardipulmonary AG Remote Control Unit (Model 939401) 41063 Type II 2008/07/31

SN080830 Zimmer Miller Bone Cement Injector Front Cartridge Kit (Model 00-5069-052-00) 43002 Type II 2008/07/31

SN080831 42982 Type II 2008/07/31

SN080832 Biomet 3I Navigator Surgical Guide Kit (SGKIT) 42387 Type II 2008/07/31

SN080833 Fisher Scientific Formalin Neutral Buffered 10% (Model SF-100-20, SF100-4) 42764 Type II 2008/07/31

SN080834 42696 Type II 2008/07/31

SN080835 Becton Dickson BBL MGIT Mycrobacteria Growth Tubes, Bactec MGIT 960 PZA Kit 41508 Type II 2008/07/31

Philips A) Brilliance 40/64 Slice CT System, B) Brilliance CT Big Bore System-Main Unit, C) Brilliance CT System (16P), D) Brilliance 6/10/16 Slice CT System Health Canada

Health Canada

Health Canada


Health Canada

Health Canada

Health Canada

Health Canada

Health Canada

Health Canada

Stryker Howmedica Ostenoics Corporation Scorpio 7000 Tibial Impactor Extractor (Model 3770-000) Health Canada

Health Canada

Health Canada

Wright Medical Technology Dynasty Trial Shell (Model 3300GG62, 3300GH64, 3300GH66, 3300GH68) Health Canada

Health Canada


















Local Agent

N/A N/A


N/A N/A

N/A N/A


Biomerieux China Ltd (HK) N/A

N/A N/A

N/A N/A


N/A N/A

N/A N/A


N/A N/A







N/A N/A

N/A N/A

N/A N/A



N/A N/A




N/A N/A


N/A N/A

N/A N/A

N/A N/A

Swedish Trading Co., Ltd N/A

Cardinal Health N/A




N/A N/A






At-Home Healthcare Company Ltd N/A

2821 5480




Elekta Ltd N/A

N/A N/A

N/A N/A





N/A N/A


N/A N/A

Philips Medical Systems Regional Office (Asia Pacific)


N/A N/A

N/A N/A

N/A N/A

PHAROS INTERNATIONAL LTD. N/A


N/A N/A


N/A N/A

Zimmer PTE Ltd. (Hong Kong branch) 2992 0968Boston Scientific HK Ltd



N/A N/A

2821 5480


CELKI Medical Company 2268 9258

N/A N/A

N/A N/AN/A N/A

N/A N/A

N/A N/A

2821 5480





N/A N/A


N/A N/A


Bayer Healthcare 2814 4836

N/A N/A




N/A N/A

N/A N/A

N/A N/A

N/A N/A

N/A N/A


N/A N/A




2919 1300

Arjo Far East Ltd 2508 9553

N/A N/A

N/A N/A

N/A N/A

N/A N/A


N/A N/A

N/A N/A

N/A N/A

N/A N/A

N/A N/A

N/A N/A

2821 5480




N/A N/A

N/A N/A

2821 5480

Medtronic International Ltd




2821 5480

Biomet Microfixation N/A







2821 5480




Ositek Inc Ltd 8121 6601

N/A N/A

N/A N/A





Monthly Summary of Medical Device Safety Alerts -June 2008*Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada


SN080601 Baush and Lomb Zyoptix Treatment Calculator (Versions 1.1 and 1.2) Bausch and Lomb N/A Firm Initiated Field Action 2008/06/02

SN080602 Boston Scientific FilterWire EZT Embolic Protection Systems N/A Firm Initiated Field Action 2008/06/02

SN080603 Hitachi Hi-Vision Ultrasound System 2008/005/006/291/003 FSCA 2008/06/02SN080604 Siemens ADVIA Centaur CP 2008/005/013/041/007 FSCA 2008/06/02SN080605 Thermogenesis Vapor Bypass Assembly (110v/220v) 2008/005/014/061/004 FSCA 2008/06/02SN080606 Varian TPS Eclipse N/A N/A 2008/06/03SN080607 Stryker Kinemax Plus Revision TS Tibial Insert 2008/005/009/121/006 FSCA 2008/06/04

SN080608 Abbott Clinical Chemistry Iron/Magnesium Calibrator (Model 1E69-03) 42116 Type II 2008/06/05

SN080609 AGA Medical Amplatzer PFO Occluder 41996 Type II 2008/06/05

SN080610 Arrow Balloon Temporary Pacing Catheter Kit 41991 Type II 2008/06/05

SN080611 BHM Ergiscake Scake abd Swivel Bar 41995 Type II 2008/06/05

SN080612 Bio-Rad Liquicheck Cardiac Markers Level 1, 2, 3, Plus Control and minipak 41858 Type II 2008/06/05

SN080613 Bio-Rad Varient B-Thalassemia Short Program 42066 Type II 2008/06/05

SN080614 42115 Type II 2008/06/05

SN080615 Cook Hilal Embolization Coils 42174 Type II 2008/06/05SN080616 Hill-Rom 100 Low Beds 41708 Type II 2008/06/05

SN080617 42021 Type I 2008/06/05

SN080618 Johnson and Johnson Depuy Lupine BR Anchor With Orthocord 42075 Type II 2008/06/05

SN080619 Johnson and Johnson Ortho-Clinical Diagnostics Blood Gruping Reagent Anti-S 42071 Type II 2008/06/05

SN080620 40792 Type II 2008/06/05

SN080621 Nova Biomedical Statstrip Glucose Hospital Meter 42078 Type II 2008/06/05

SN080622 Oxoid Haemophilus Selective Agar 42190 Type II 2008/06/05

SN080623 Philips Brilliance CT 16 Power Slice 40156 Type II 2008/06/05

SN080624 Philips Suresigns VS3 Vital Signs Monitor 42049 Type II 2008/06/05

SN080625 Pulmonetic Systems LTV 800, 950, 900 and 1000 Series Ventilators 41278 Type II 2008/06/05

SN080626 Randox Triglycerides 41875 Type II 2008/06/05

SN080627 Roche Elecsys Progesterone II 41845 Type II 2008/06/05

SN080628 Stryker SDC Ultra 40955 Type II 2008/06/05SN080629 Tyco CT 9000 ADV Injector with Console 42024 Type II 2008/06/05

SN080630 Tyco Optivantage DH Power Injection System 42026 Type II 2008/06/05

SN080631 Walter Lorenz Surgical Epker Osteotome (BOTH Slightly Curved and Straight) 41577 Type II 2008/06/05



MHRAMHRAMHRAAffapsMHRA

Health CanadaHealth CanadaHealth CanadaHealth Canada

Health Canada

Health CanadaCardinal Health Sterile Mammoplasty Pack, Sterile Total Knee Pack and Othopedie-Fusion Posterieure Health Canada


Imaging Sciences I-CAT 17-19, 3D Dental Imaging System (Model 1-10-1-0) and I-Cat 3D Imaging System- Main Unit (Model 9140-0000-0000) Health Canada

Health Canada

Health Canada

Medtronic Lifepak Internal Defibillator Electrodes, Lifepak 9, 9p, 12 & 20 Int. Defibillator Handles Health Canada

Health CanadaHealth CanadaHealth CanadaHealth CanadaHealth CanadaHealth CanadaHealth CanadaHealth CanadaHealth CanadaHealth Canada

Health Canada




http://afssaps.sante.fr/



























SN080632 Zimmer Dermacarriers Skin Graft Carriers and Dermacarriers II Skin Graft Carriers 42114 Type II 2008/06/05

SN080633 AquaJoy battery chargers (Serial no. 0638) 2007/011/026/401/005 FSCA 2008/06/06

SN080634 IBG Immucor Galileo Echo 2008/005/015/061/008 FSCA 2008/06/06

SN080635 Innogenetics INNO-LIA Syphilis Score (Product code 80542) 2008/005/020/061/019 FSCA 2008/06/06

SN080636 Bausch & Lomb Zyoptix XP Microkeratome Motors (ZXP09183) 2008/005/008/181/011 FSCA 2008/06/10

SN080637 Gambro Ultra filter U 8000 S (batch no. 8-3011-H-01) 2008/005/022/061/017 FSCA 2008/06/10

SN080638 Philips Motiva Remote Patient Management System 2008/005/013/061/017 FSCA 2008/06/10

SN080639 Zimmer NexGen Complete Knee Solution Articular Surface Insertion Instrument 2008/005/021/061/004 FSCA 2008/06/10

SN080640 CMS XiO/Focal 2008/003/022/601/200 FSCA 2008/06/11

SN080641 GE Healthcare OEC Uroview 2800, 9800 Plus, MiniView 6800, Flexiview 8800 Mobile C-Arm 2008/003/031/061/005 FSCA 2008/06/11

SN080642 Siemens Mevatron and Oncor Control Console Versions V6.5.079, V7.2.079 and V9.1.50 2008/005/001/291/016 FSCA 2008/06/11

SN080643 Boston Scientific NAMIC MorseR Angiographic Manifold N/A Firm Initiated Field Action 2008/06/12

SN080644 CalMed Pericardial Sump Z-1175-2008 to Z-1177-2008 Class II 2008/06/12

SN080645 Z-1710-2008 to Z-1712-2008 Class II 2008/06/12

SN080646 GE Healthcare Proteus XR/a Radiographic System (Model Number 2259976) Z-0842-2008 Class II 2008/06/12

SN080647 Siemens ADVIA Centaur Tnl-Ultra Assay, Troponin Immunoassay Z-0580-2008 Class II 2008/06/12

SN080648 Accuray CyberKnife - Axum/Standard Treatment Couch Accuray Asia Ltd N/A Firm Initiated Field Action 2008/06/16

SN080649 BD Obturators for Venflon, Insyte and Adsyte Pro 2008/005/022/061/020 FSCA 2008/06/17

SN080650 2008/005/021/601/353 FSCA 2008/06/17

SN080651 GE Healthcare 3.0T Signa HD Scanner (3.0T Propeller T2 Flair application) 2008/005/030/061/027 FSCA 2008/06/17

SN080652 GE Healthcare Advantage Workstation 2008/005/030/061/023 FSCA 2008/06/17

SN080653 GE Healthcare Centricity PASCS Software versions: 3.0.0X, 3.0.1X, 3.0.2.X AND 3.0.3X 2008/006/003/291/010 FSCA 2008/06/17

SN080654 GE Healthcare DST-XL Carmera 2008/005/030/061/024 FSCA 2008/06/17

SN080655 GE Healthcare Innova 2100IO, 3100/3100IQ and 4100/4100IQ Cardiovascular X-ray System 2008/005/030/061/034 FSCA 2008/06/17

SN080656 GE Healthcare OEC 9900, 9800 and 8800 series 2008/005/030/061/025 FSCA 2008/06/17

SN080657 GE Healthcare Pressure Sensitive Device (PSD) 2008/003/025/061/015 FSCA 2008/06/17

SN080658 GE Healthcare S/5 iCentral versions L-NET03, L-NETC03, L-NET05, L-NETC05 2008/005/002/601/317 FSCA 2008/06/17

SN080659 Hansen Medical Artisan Control Catheter 2008/005/028/061/019 FSCA 2008/06/17

SN080660 Johnson and Johnson Ethicon Endo-Surgery ENDOPATH ETS 35mm 2008/005/009/121/011 FSCA 2008/06/17

SN080661 Philips X-Ray Systems with Monitor Ceiling Suspension 2008/006/003/291/004 FSCA 2008/06/17

Health Canada

MHRAMHRAMHRAMHRAMHRAMHRA

MHRA

MHRA

MHRA

MHRA


FDA

Cardinal Health U19 Socketed Integrated Circuit ("U19 IC"), Grey Inter-Unit Interface Connectors ("IUI") and U9 Socket Integrated Circuit ("U9 IC") FDA

FDA

FDA

MHRAGalemed EMS Ventilator Single use non rebreathing patient circuit (Product code: W196-002; Lot 20070709) MHRA

MHRA

MHRA

MHRA

MHRA

MHRA

MHRAMHRA

MHRA

MHRAMHRAMHRA






























SN080662 Siemens ADVIA 1200, 1650, 1800 and 2400 Chemistry Systems 2008/005/029/061/019 FSCA 2008/06/17

SN080663 Specialised Orthotic Services Mojo, Maxi, Midi and Mini 2008/003/007/261/001 FSCA 2008/06/17

SN080664 Stryker Secure II, Epic and Zoom Beds 2008/003/006/061/012 FSCA 2008/06/17

SN080665 B Braun A/V Sets (Product Code 7210697) 2008/005/015/401/001 FSCA 2008/06/19

SN080666 Boston Scientific NexStent Carotid Stent & MonorailR Delivery System N/A Firm Initiated Field Action 2008/06/19

SN080667 Cardinal Health LTV ventilators 2008/006/009/291/011 FSCA 2008/06/19

SN080668 Covidien Thoraseal II chest drainage unit MDA/2008/040 MDA 2008/06/19

SN080669 GE Healthcare Precision 500D and Advantx Legacy R&F X-ray Systems 2008/005/030/061/029 FSCA 2008/06/19

SN080670 GE Healthcare Engstrom Carestation 2007/008/029/401/001 FSCA 2008/06/19

SN080671 Handicare Ibis XP power wheelchair 2007/010/009/401/003 FSCA 2008/06/19

SN080672 Nottingham Rehab Supplies Columbia Toilet Support 2007/012/018/401/006 FSCA 2008/06/19

SN080673 Baxa Exacta-Mix? 2400 Compounder 2008/006/012/601/405 FSCA 2008/06/23

SN080674 BioMerieux VIDAS HBs AG Ultra 2008/005/027/601/367 FSCA 2008/06/23

SN080675 Z-1156-2008 to Z-1159-2008 Class II 2008/06/23

SN080676 Boston Scientific Platinum PlusT Coronary Guidewire N/A Firm Initiated Field Action 2008/06/23

SN080677 Boston Scientific Safety PEG Kits N/A Firm Initiated Field Action 2008/06/23

SN080678 Conmed DetachaTip Surgical Instruments 2008/006/009/291/009 FSCA 2008/06/23

SN080679 GE LOGIQ3 Expert ultrasound scanner with software versions 4.0.5, 4.1.1 and 4.1.2 Z-1155-2008 Class II 2008/06/23

SN080680 Huntleigh Healthcare Arjo Malibu 2007/009/007/301/001 FSCA 2008/06/23

SN080681 Kimal Safety Fistula Needle 2008/006/011/601/402 FSCA 2008/06/23

SN080682 Metrax Primedic Charger Basis 2008/006/011/291/005 FSCA 2008/06/23

SN080683 PDG Bentley Manual Tilt Wheelchair 2008/002/005/301/001 FSCA 2008/06/23

SN080684 Roche Diagnostics COBAS Integra 400 systems 2008/006/005/291/003 FSCA 2008/06/23

SN080685 Siemens Medical Solutions Diagnostics Advia 120 & Advia 2120 2008/006/009/061/007 FSCA 2008/06/23

SN080686 St Jude Medical Livewire TC Ablation Catheter 2008/006/013/291/011 FSCA 2008/06/23

SN080687 ThermoFisher Scientific PB0124A Columbia agar with chocolated horse blood 2008/006/013/601/408 FSCA 2008/06/23

SN080688 Unomedical OP tubing (Lot No 182281) 2008/001/022/401/007 FSCA 2008/06/23

SN080689 Varian Medical Systems VARIS Vision/System 6.5 2008/006/002/291/007 FSCA 2008/06/23

SN080690 Waldemar Link Megasystem-C Modular Components 2008/004/010/061/011 FSCA 2008/06/23

SN080691 Coloplast Balloon Nephrostomy catheter with introducer (Ref. no. AJ6812 - AJ6822) Coloplast (Hong Kong) Ltd N/A Firm Initiated Field Action 2008/06/25

SN080692 Boston Scientific implantables devices, ICD and CRT-D N/A Firm Initiated Field Action 2008/06/26

SN080693 Computerized Medical Systems XIO Radiation Treatment Planning System 42336 Type II 2008/06/27

MHRA

MHRA

MHRAMHRA


MHRAMHRA

MHRA

MHRAMNRAMHRAMHRAMHRA

Bio-Rad BIOPLEX 2200 SYPHILIS IgG Kit, EBV IgG KIT, CALIBRATORS, AND CONTROLS and MULTI-ANALYTE DETECTION SYSTEM FDA



MHRA

FDAMHRAMHRAMHRAMHRAMHRAMHRAMHRA

MHRA

MHRAMHRAMHRA


Health Canada





























SN080694 42273 Type II 2008/06/27

SN080695 Gambro cartridge blood set (Model 003410-510, 003410-710, 0141080XXXC) 42069 Type II 2008/06/27

SN080696 Maquet HL 30 Perfusion System 41066 Type II 2008/06/27

SN080697 Stryker Infravision Urethral Kit (Model 0220-180-516) 42415 Type II 2008/06/27

SN080698 Terumo Level Sensor II Pads, Gel included 41365 Type II 2008/06/27

SN080699 Medtronic Affinity NT Hollow Fiber Oxygenator Model CB511) 42402 Type II 2008/06/27

SN080700 40766 Type II 2008/06/27

SN080701 ITC Protime Microagulation System (Model PROTIMEPST) 39337 Type II 2008/06/27

SN080702 Thermogenesis Autoxpress Platform System (Model 8-5101-0) 41781 Type II 2008/06/27

SN080703 Immucor Corqc Test System, Panoscreen I/II/III (Model) 42166 Type II 2008/06/27

Philips Isite Ipacs (Model ISITE ENTERPRISE V.3.5, ISITE RADIOLOGY V.3.5, IVAULT V.3.5) Health Canada

Health Canada


GE Advantx LCLP+ Bi Plane Cardiac System, Advantx LCN+Angiographic System, Innova 2000 Cardiovascular System, Innova 2100 IQ Digital Imaging System, Innova 4100IQ Tables Health Canada













Local Agent

Baush and Lomb 2213 3371


N/A N/ASiemens Ltd. 2810 7533

N/A N/AN/A N/A



AGA Medical Corporation (Asia Pacific) N/A

N/A N/A




Cardinal Health N/A

Cook Asia (Hong Kong) Ltd. 2781 0232N/A N/A

N/A N/A




N/A N/A

N/A N/A

Philips Electronics Hong Kong Ltd. 2876 7525


N/A N/A

N/A N/A

Roche Diagnostics (Hong Kong) Limited 2485 7510

Stryker China Ltd 2518 6988COVIDIEN 3157 7220

COVIDEN 3157 7220

N/A N/A




N/A N/A

N/A N/A

N/A N/A


Gambro China Ltd 2839 7010



N/A N/A




N/A N/A

Cardinal Health N/A





N/A N/A









N/A N/A

Johnson & Johnson Medical Hong Kong 2738 2818Philips Electronics Hong Kong Ltd. 2876 7525



N/A N/A


B Braun Medical Hong Kong 2277 6125Boston Scientific Hong Kong Ltd 2960 7136

Cardinal Health N/A

COVIDIEN 3157 7220



N/A N/A

N/A N/A

N/A N/A

Biomerieux China Ltd (HK) 2356 7033




N/A N/A



N/A N/A

N/A N/A

N/A N/A

2485 7510

2810 7533

St Jude Medical 2996 7601

N/A N/A

N/A N/A

N/A N/A

N/A N/A

Coloplast (Hong Kong) Ltd 3628 7428


N/A N/A

Roche Diagnostics (Hong Kong) Ltd

Siemens Ltd


2821 5480





Medtronic-Mediland (Taiwan) Ltd 2919 1300


N/A N/A

N/A N/A

N/A N/A



Monthly Summary of Medical Device Safety Alerts -May 2008*Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada


SN080501 Z-1165-2008 Class II 2008/05/02

SN080502 Z-0661-2008 Class II 2008/05/02

SN080503 Respironics Various Devices and Accessories Z-1055-2008 to Z-1093-2008 Class II 2008/05/02

SN080504 Truelife walking frames for adults and children MDA/2008/031 MDA 2008/05/02

SN080505 Bausch & Lomb XP MicroKeratome motors Baush and Lomb N/A Firm Initiated Field Action 2008/05/05

SN080506 Accuray Asia Ltd N/A Firm Initiated Field Action 2008/05/05

SN080507 Phonak Rubber Dome BTE hearing instruments 2007/011/020/061/002 FSCA 2008/05/07

SN080508 2008/004/011/061/016 FSCA 2008/05/07

SN080509 Stryker Advanced Cement Mixer (ACM) Bowl and Base (REF 306-554) Z-1106-2008 Class II 2008/05/08

SN080510 GE Healthcare Centricity PACS RA1000 Workstation Z-1104-2008 Class II 2008/05/08

SN080511 Siemens Coherence AG Therapist Z-0971-2008 to Z-0981-2008 Class II 2008/05/08

SN080512 Seradyn QMS Vancomycin Reagents (Part Nimber 0373589) Z-1102-2008 Class II 2008/05/08

SN080513 Siemens Advia Centaur System and Advia Centaur XP System 41756 Type II 2008/05/08

SN080514 Siemens Dimension TPSA Flex Reagent Cartridge 41721 Type II 2008/05/08

SN080515 Siemens Mevatron and Oncor Linear Accelerators 34725 Type II 2008/05/08

SN080516 Medtronic Hall Easy-Fit Prosthetic Heart VALVE (Aortic and Mitral) 41777 Type II 2008/05/08

SN080517 Medtronic Bravo PH Capsule With Delivery System 39316 Type II 2008/05/08

SN080518 Varian Medical Clinac High and Low Engery 41305 Type II 2008/05/08

SN080519 Cardinal Health Custom Sterile Total Joint Pack 41543 Type II 2008/05/08

SN080520 Convatec Gentle Touch 70mm Colo/Ileo PostOp Kit 41524 Type II 2008/05/08


Abbott CELL-DYN Hemoglobin Reagent Syringe (Product Descriptiion: CDS HGB SRNGW/BU) FDA

Siemens ACUSON Sequoia Diagnostic Utrasound System (Material Number 8245875, 8246951,8267697) FDA

FDA

MHRA

Accuray CyberKnife Robotic Radiosurgery System MultiPlan Treatment Planning Sofetware (Catalog No 022986)

MHRA

Edwards Lifesciences Aquarius Regular Haemofiltration Machine with software version 4.01.11 MHRA

FDA

FDA

FDA

FDA

Health Canada

Health Canada

Health Canada

Health Canada

Health Canada

Health Canada

Health Canada

Health Canada











http://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/_list/rec-ret_md-im_date_apr-june_2008_e.html









SN080521 National Biological Houva III 41407 Type II 2008/05/08

SN080522 Biosense Webster Lasso Variable Deflectable CIR Map Catheter 41774 Type II 2008/05/08

SN080523 Levitronix CentriMag Systems 41786 Type II 2008/05/08

SN080524 Medtronic Heparin-Coated products N/A Firm Initiated Field Action 2008/05/08

SN080525 Biomerieux Vitek GPS Quinupristin/Dalfoprist Cards 41574 Type II 2008/05/08

SN080526 Johnson and Johnson Ortho-Clinical Diagnostics Vitros 5,1 FS Chemistry System 41659 Type II 2008/05/08

SN080527 BHM Medical Medi-Lifter II Plus Patient Lift and Summit 41705 Type I 2008/05/08

SN080528 A.L.N. Vena Cave Filter / Introduction Kit 41639 Type I 2008/05/08

SN080529 Biomet 3i Certain Microminiplant Healing abutment 41552 Type II 2008/05/08

SN080530 Bio-Rad Liquicheck Sedimentation Rate Control 41293 Type II 2008/05/08

SN080531 Aidapt Isis shower board (Code No. R232) 2008/004/009/301/001 FSCA 2008/05/08

SN080532 Covatec Active Life Little One (20917) Convatec N/A Firm Initiated Field Action 2008/05/09

SN080533 Zimmer Hemovac, HAS, Sergivac, Infection Control and Mini-Hemovac Systems 2008/004/008/291/002 FSCA 2008/05/09

SN080534 Boston Scientific iReview SoftwareVer1.0 N/A Firm Initiated Field Action 2008/05/14

SN080535 Boston Scientific OMG Connector-A N/A Firm Initiated Field Action 2008/05/14

SN080536 Smiths Medical BCI Mini-Torr Plus NIBP Monitor with SpO2 & Built-in Printer, 6004 2008/004/015/061/013 FSCA 2008/05/14

SN080537 P3 Medical Robertshaw Endobronchial tubes (PVC, Disposable) 2007/012/022/601/001 FSCA 2008/05/14

SN080538 Fisher & Paykel Healthcare Patient Warmers 2008/004/022/061/020 FSCA 2008/05/14

SN080539 Gambro Spectra Optia Apheresis System 2008/004/023/061/013 FSCA 2008/05/14

SN080540 Thoratec HeartMate II LVAS 2008/004/023/291/003 FSCA 2008/05/14

SN080541 Z-1118-2008 Class II 2008/05/15

SN080542 Medefil Heparin I.V. Flush Syringe Z-1543-2008 to Z-1545-2008 Class II 2008/05/15

SN080543 Siemens ADVIA Centaur HAV IgM Z-1119-2008 Class II 2008/05/15

SN080544 Philips Healthcare iSite PACS image management system Z-1141-2008 Class II 2008/05/15

SN080545 Tyco Healthcare Monoject Prefill Z-1594-2008 to Z-1602-2008 Class II 2008/05/15

Health Canada

Health Canada

Health Canada

Medtronic International Ltd

Health Canada

Health Canada

Health Canada

Health Canada

Health Canada

Health Canada

MHRA

MHRA



MHRA

MHRA

MHRA

MHRA

MHRA

Fisher Healthcare Sure-Vue Serum/Urine hCD-STAT (Catalog no. FHC-A202, Product Codes: FHC-A202-KFI3O and FHC-A202-KFI5O) FDA

FDA

FDA

FDA

FDA




http://wwwp.medtronic.com/Newsroom/NewsReleaseDetails.do?itemId=1210169701845&lang=en_US




















SN080546 Boston Scientific Cutting Balloon Ultra Microsurgical Dilatation Device N/A Firm Initiated Field Action 2008/05/16

SN080547 Boston Scientific LeVeen SuperSlimT Needle Electrodes N/A Firm Initiated Field Action 2008/05/16

SN080548 Baxter HomeChoice Automated Peritoneal Dialysis System (Software v.10.210) Baxter Healthcare Ltd N/A Firm Initiated Field Action 2008/05/16

SN080549 Boston Scientific iLab UltraSound Imaging System 2008/004/024/061/011 FSCA 2008/05/19

SN080550 Johnson and Johnson Codman ARCHIMEDES Drug Pumps 2008/004/021/061/008 FSCA 2008/05/19

SN080551 Respironics Humidifier Chambers 2008/003/028/401/001 FSCA 2008/05/19

SN080552 Firstar Plastic Vaginal Speculum 2007/011/014/401/001 FSCA 2008/05/19

SN080553 Dragonmobility Power-chairs 2008/001/017/301/001 FSCA 2008/05/19

SN080554 Waldemar Link Megasystem-C Modular Components 2008/004/010/060/011 FSCA 2008/05/21

SN080555 Biotrin Nephkit Alpha GST EIA (Product Code: BIO66NEPHA, Lot no 58KT036) 2008/004/030/061/013 FSCA 2008/05/21

SN080556 Chiltern Invadex Shower Trolleys and Shower/Changing Stretchers 2007/012/033/401/004 FSCA 2008/05/21

SN080557 Smiths Medical Graseby Omnifuse and Omnifuse PCA Syringe Pumps 2008/003/006/061/008 FSCA 2008/05/21

SN080558 Welch Allyn AED 10 2008/004/016/061/023 FSCA 2008/05/21

SN080559 VIASYS AVEA Ventilator Z-0982-2008 to Z-0986-2008 Class II 2008/05/22

SN080560 Cardinal Health AirLife Infant Ncpap System Driver Z-0987-2008 Class II 2008/05/22

SN080561 Z-1138-2008 Class II 2008/05/22

SN080562 Stryker Triathlon Baseplate Impactor Extractor (Catalog no. 6541-4-805) Z-1105-2008 Class II 2008/05/22

SN080563 Z-1103-2008 Class II 2008/05/22

SN080564 Medtronic LIFEPAK 12 and LIFEPAK 20/20e Defibrillator/Monitor 2008/004/024/061/014 FSCA 2008/05/22

SN080565 2008/004/003/061/010 FSCA 2008/05/22

SN080566 2008/004/029/061/002 FSCA 2008/05/22

SN080567 B Braun Dialog+ Machines with DF Option 2008/004/023/061/009 FSCA 2008/05/22

SN080568 Sysmex CS-Series - Coagulation Analyser (all versions) 2008/004/025/061/001 FSCA 2008/05/22

SN080569 Biotrin Urinary Collagen IV EIA (Catalog Code BIO83) 2008/004/001/061/002 FSCA 2008/05/22

SN080570 Masimo Rainbow Rad-57 Pluse CO-Oximeter MDA/2008/033 MDA 2008/05/22



MHRA

MHRA

MHRA

MHRA

MHRA

MHRA

MHRA

MHRA

MHRA

MHRA

FDA

FDA

Siemens Syngo US Workplace Picture Archiving and Communication System, software version 2.0, 94043 FDA

FDA

Abbott White Blood Cell (WBC) Reagent-Part A used with the CELL-DYN 4000 and CELL-DYN Sapphire Systems , Red cell lysing reagent (List No. 01H77-01) FDA

MHRA

Stryker Pegless Universal Scorpio Notch Guide (Catalog no 8000-3303) and Universal Scorpio Notch Preparation Guide (Catalog no 7650-3363) MHRA

Dade Behring Enzygnost Toxoplasmosis/IgG (OUNA27) in combination with Sample Buffer POD lot 426707 MHRA

MHRA

MHRAMHRAMHRA
























SN080571 Dade Behring Stratus CS Cardiac Troponin I Calpak (CCTNI-CR) 2008/004/030/601/310 FSCA 2008/05/23

SN080572 Dade Behring N Latex CDT Kit (OPCS03) and N Latex CDT (kit) (OPCS05) 2008/004/029/061/003 FSCA 2008/05/23

SN080573 Dade Behring Dimension Clinical Chemistry System 2008/004/017/601/273 FSCA 2008/05/23

SN080574 2008/004/028/601/297 FSCA 2008/05/23

SN080575 Siemens ACUSON Antares, Ultrasound System 41792 Type II 2008/05/23

SN080576 Biosite Triage MeterPro 41867 Type II 2008/05/23

SN080577 Cardinal Health Custom Sterile Hip Pack 41842 Type II 2008/05/23

SN080578 Draeger Medical Oxylog 3000 41844 Type II 2008/05/23

SN080579 Johnson and Johnson STERRAD Sterilization Systems Oil Mist N/A Firm Initiated Field Action 2008/05/23

SN080580 Boston Scientific RotaWire Guidewire N/A Firm Initiated Field Action 2008/05/26

SN080581 ThermoFisher Scientific LAB VISION Pretreatment Module 2008/005/009/121/004 FSCA 2008/05/26

SN080582 Invacare Harrier Heavy Duty (HD) Powered Wheelchairs 2007/010/018/061/002 FSCA 2008/05/26

SN080583 Pointe Scientific Liquid ALT (SGPT) reagent set Z-1110-2008 to Z-1117-2008 Class II 2008/05/29

SN080584 Park House Healthcare VERSAtec Back 2007/009/012/301/002 FSCA 2008/05/29

SN080585 BPR Medical FireSafe Cannula Valves (Firebreak) 2008/004/008/061/008 FSCA 2008/05/29

SN080586 Gambro Hospal Blood Set 2008/005/013/061/013 FSCA 2008/05/29

SN080587 Invacare Storm and Storm True Track (TT) wheelchairs MDA/2008/035 MDA 2008/05/29

MHRA

MHRA

MHRABeckman Coulter Access and Access 2 Immunoassay Systems, SYNCHRON LXi 725 System and UniCel DxC 600i System MHRA




MHRAMHRAFDA

MHRAMHRAMHRAMHRA

















Local Agent




N/A N/A



N/A N/A

N/A N/A




N/A N/A






Varian Medical Systems Pacific Inc. N/A

N/A N/A

2519 9182


Convatec, A Division of E.R. Squibb & Sons, L.L.C. (Hong Kong)


N/A N/A

N/A N/A

N/A N/A


Biomerieux (Hong Kong) 2356 7033


N/A N/A

N/A N/A

Ositek Inc Ltd 8121 6601


N/A N/A

2519 9182




Goodwin Health Care Holdings Ltd 2408 8838

Ultra Care Company Ltd N/A

N/A N/A


N/A N/A

N/A N/A

N/A N/A



COVIDIEN 3157 7244

Convatec, A Division of E.R. Squibb & Sons, L.L.C. (Hong Kong)








Firstar Healthcare Co., Ltd N/A

N/A N/A

N/A N/A

N/A N/A

N/A N/A


N/A N/A

VIASYS Healthcare (Hong Kong) Ltd 6305 5575

N/A N/A






Dade Behring HK Ltd., A Siemens Company 2810 7533


N/A N/A

N/A N/A

N/A N/A





Beckman Coulter 2240 6260


N/A N/A

Cardinal Health N/A




N/A N/A

N/A N/A

N/A N/A

N/A N/A

N/A N/A


N/A N/A


Monthly Summary of Medical Device Safety Alerts -April 2008*Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada


SN080401 Smith & Nephew Medullary Exchange Tube (Product Code 415113, Lot 07AM1186) 2007/004/019/601/816 FSCA 2008/04/03

SN080402 Varian CT/MR Ring and Tandem Combination Applicator Set (AL13017000) 2008/003/017/061/004 FSCA 2008/04/03

SN080403 Edwards Lifesciences VAMP Jr 2008/003/017/061/015 FSCA 2008/04/03

SN080404 BrainLAB BrainScan 2008/003/013/061/024 FSCA 2008/04/03

SN080405 LIFEPAK 20 Defibrillator/monitor Z-1050-2008 Class II 2008/04/03

SN080406 Terumo Cardiovascular Procedure Kit (P/N 70932-01, 64789-01, 70295-02, 70579-04) Z-1310-2008 to Z-1313-2008 Class II 2008/04/03

SN080407 Pointe Scientific Liquid Alkaline Phosphatase Reagent Set Z-1353-2008 to Z-1360-2008 Class II 2008/04/03

SN080408 AMO WHITESTAR SIGNATURE Phacoemulsification System (NGP680300) AMO Asia Limited N/A Firm Initiated Field Action 2008/04/07

SN080409 ConMed Linvatec Hall Surgical Blades, Sterile, Single-use, packaged in Bilsters 2008/003/017/291/001 FSCA 2008/04/08

SN080410 2008/003/019/061/007 FSCA 2008/04/08

SN080411 Hospira Butterfly winged needle infusion set MDA/2008/023 MDA 2008/04/09

SN080412 Skryker ACL Workstation slider (Model Number: 234-010-503) Z-1107-2008 Class II 2008/04/10

SN080413 Hill-Rom Affinity 4 Birthing Bed (Model P3700B) Z-0617-2008 Class II 2008/04/10

SN080414 Siemens Mevatron, Oncor, Primus Linear Accelerators Z-1394-2008 to Z-1407-2008 Class II 2008/04/10

SN080415 Leica Bond maX systems with cversion 03.05.08 Software instaled 2008/003/013/291/008 FSCA 2008/04/10

SN080416 2008/003/013/291/014 FSCA 2008/04/11

SN080417 Medivance Instruments Velopex Extra X 2008/001/003/061/013 FSCA 2008/04/11

SN080418 Thermogenesis Disposable Processing Set for the AXP System 8-5101 2008/003/012/061/002 FSCA 2008/04/11

SN080419 Elekta Stereotactic Body Frame CT and MRI indicators 2008/002/029/601/139 FSCA 2008/04/14


MHRA

MHRA

MHRA

MHRA

FDA

FDA

FDA

MHRA

RITA Starburst XLie Radiofrequency Ablation Probe and Talon Radiofrequency Ablation Probe MHRA

MHRA

FDA

FDA

FDA

MHRA

Stryker Scorpio Knee Femoral Component (Catalog No. 70-5211R, 71-5211R, Lot Code: KNAMED, V8WMED) MHRA

MHRA

MHRA

MHRA




















SN080420 Abbott OPTIUM-H Blood Glucose Test Strips (Lot no. 53929/ Part No. 80111-01) 2008/003/025/061/013 FSCA 2008/04/14

SN080421 Arcomedical 3101-TJ (FSB123) Blood Set with Lower Y site (Batches C8446) 2008/003/013/601/181 FSCA 2008/04/14

SN080422 Boston Scientific RX Plastic Biliary Stents N/A Firm Initiated Field Action 2008/04/15

SN080423 Boston Scientific Precision Implantable Pluse Generator (UPN M365SC11100) N/A Firm Initiated Field Action 2008/04/15

SN080424 Boston Scientific Mach 1 Guide Catheter N/A Firm Initiated Field Action 2008/04/15

SN080425 Boston Scientific Single-Use Rotatable Snares N/A Firm Initiated Field Action 2008/04/15

SN080426 Boston Scientific SteeroCath-Dx and SteeroCath-T Catheters N/A Firm Initiated Field Action 2008/04/15

SN080427 N/A Firm Initiated Field Action 2008/04/16

SN080428 Boston Scientific Smash Balloon Dilation Catheter N/A Firm Initiated Field Action 2008/04/16

SN080429 Boston Scientific Various Products N/A Firm Initiated Field Action 2008/04/16

SN080430 Zimmer Hemovac Wound Drainage Device Infection Control Kits Z-1448-2008 to Z-1458-2008 Class II 2008/04/17

SN080431 Z-0689-2008 Class II 2008/04/17

SN080432 Myelotec Steerable Video Guided Catheter (Product Code 2000 and 2010) Z-0586-2008 to Z-0587-2008 Class II 2008/04/17

SN080433 CES Ultra, Cranial Electrotherapy Stimulator Z-0712-2008 Class II 2008/04/17

SN080434 Z-0916-2008 Class II 2008/04/17

SN080435 Nonin Model 2500 PalmSAT handheld pluse Oximeter Z-0843-2008 Class II 2008/04/17

SN080436 Abbott Vascular Xact Rapid Exchange Carotid Stent System 2008/003/031/291/008 FSCA 2008/04/17

SN080437 2007/012/021/401/014 FSCA 2008/04/18

SN080438 2008/002/028/601/134 FSCA 2008/04/18

SN080439 Huntleigh Healthcare Well-Shin WS-023 power lead adapters MDA/2008/027 MDA 2008/04/18

SN080440 Huntleigh Healthcare Birthright birthing bed mattresses MDA/2008/026 MDA 2008/04/18

SN080441 BHM Medical Maxi Sky 600, V4 and V4i Ceiling Lifts 41375 Type II 2008/04/21

SN080442 Smiths Medical BCI 3180 Pulse Oximeter (Model 3180) 41371 Type II 2008/04/22

SN080443 Biohorizons Implant System Ratchet Extender (Model # 300-205) 41433 Type II 2008/04/22

MHRA

MHRA






Boston Scientific Epic Over-The-Wire Self-Expanding Nitinol Stent with Delivery System Stent System




FDA

Medtronic AneuRx AAAdvantage Endovascular Stent Graft with the Xcelerant Delivery System FDA

FDA

FDA

Ormco Grengloo (Unidose Tips), Bracket adhesive and tooth conditioner (Part Number 740-0322) FDA

FDA

MHRA

PROACT Silicone Disposable Armoured LMA SAD-LA6320, SAD-LA6325, SAD-LA3300, SAD-LA6340, SAD-LA6350 MHRA

Siemens Medical IMMULITE 2000 CEA kit L2KCE2,6 lot 232 and IMMULITE 2500 CEA kit L5KCE2,6 lot 111 MHRA

MHRA

MHRA

Health Canada

Health Canada

Health Canada














http://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/_list/rec-ret_md-im_date_jan-march_2008_e.html




SN080444 Biohorizons Single-Stage Implant System 122-800 Kit (Model 122-800) 41374 Type II 2008/04/22

SN080445 Elekta PrecisePlan (Model # MRT 7131, MRT 7161) 41295 Type II 2008/04/22

SN080446 Elekta iViewGT Electronical Portal Imaging (Model XRT 1261) 41295 Type II 2008/04/22

SN080447 Somagen IgM HRP ELISA Kit (Model LAPL-K-HRP-001GM, LAPL-K-HRP-001M) 41158 Type II 2008/04/22

SN080448 41183 Type II 2008/04/22

SN080449 Meridian Bioscience Immunocard Toxins A & B 41330 Type II 2008/04/22

SN080450 Trinity Biotech MDA Auto Dimer (Product Code T3103) 2008/004/003/061/016 FSCA 2008/04/23

SN080451 ITC AVOXimeter 1000 / AVOXimeter 1000E 2008/002/021/061/018 FSCA 2008/04/23

SN080452 MEDNET TOPS OUS Fusion System 2008/001/025/291/005 FSCA 2008/04/23

SN080453 Medfor S400 and S227 Femoral Head Storage Pot, Labelled, double wrapped 2008/002/029/601/140 FSCA 2008/04/23

SN080454 Merlin Medical Disposable pen torch (Model no. W2137) MDA/2008/028 MDA 2008/04/23

SN080455 GE Healthcare Drytec Tc-99m Generator (all sizes) N/A Firm Initiated Field Action 2008/04/24

SN080456 Cook Peel-Away Introducer set and Cook TPN Lumen Catheter set Z-0892-2008 to Z-0904-2008 Class II 2008/04/24

SN080457 BioRad BioPlex 2200 Instrument Z-0575-2008 Class II 2008/04/24

Health Canada

Health Canada

Health Canada

Health Canada

Tornier Aequalis Shoulder (Kelled Glenoid and Cemented Glenoid) and Latitude Elbow Prosthesis Cap, Radial Head and Ulnar Compon. Health Canada

Health Canada

MHRA

MHRA

MHRA

MHRA

MHRA

GE Medical Systems Hong Kong Ltd.

FDA

FDA















Local Agent

Smith & Nephew Healthcare Ltd. 2648 7700


N/A N/A

N/A N/A


Terumo China (H.K.) Ltd. 2866 0811

N/A N/A


N/A N/A

N/A N/A

Hospira Ltd 2285 8382


N/A N/A


N/A N/A


N/A N/A

N/A N/A

N/A N/A




N/A N/A











N/A N/A

N/A N/A

L&S Dental Supplies Limited 2815 8115

N/A N/A


N/A N/A


N/A N/A

N/A N/A

N/A N/A

Goodwin Health Care Holdings Ltd 2408 8838

Specialists' Dental Supplies Limited 9656 7000


Specialists' Dental Supplies Limited 9656 7000

N/A N/A

N/A N/A

N/A N/A

N/A N/A

N/A N/A

N/A N/A

N/A N/A

N/A N/A

N/A N/A

N/A N/A





Monthly Summary of Medical Device Safety Alerts -March 2008*Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada


SN080301 Focus Diagnostics HerpeSelect 1 and 2 Immunoblot IgG Kit (CATALOG# IB0900G) 40290 Type II 2008/03/03

SN080302 Zoll Medical E Series Debribillator with 12 Lead ECG 40588 Type II 2008/03/03

SN080303 Stryker Howmedica Modular Replacement System, Distal Fem 39226 Type I 2008/03/03

SN080304 Walter Lorenz Surgical Pectus Table Top Bender (Trading as: Biomet Microfixation) 39755 Type II 2008/03/03

SN080305 Balt Extrusion Goldbal Detachable Balloons 39555 Type II 2008/03/03

SN080306 Roche Accutrend GC 39757 Type II 2008/03/03

SN080307 Stryker Howmedica Trident acetabular shell and Trident hemispherical shell 40619 Type II 2008/03/03

SN080308 Elekta Precise Plan 40747 Type II 2008/03/03

SN080309 Elekta Precise Treatment Table 40457 Type II 2008/03/03

SN080310 Elekta Leksell GammaPlan 8.0 40497 Type II 2008/03/03

SN080311 Abbott Cell Dyn Sapphire Analyzer (model # 08H00-01) 40557 Type II 2008/03/03

SN080312 B Braun Aesculap FT420T-FT430T Caspar Aneurysm Clips APP 40744 Type I 2008/03/03

SN080313 Conmed Endoscopic Ligating Clip Applier (ELC) 39961 Type II 2008/03/03

SN080314 Technidata TD-Synergy V03.11.A 40014 Type II 2008/03/03

SN080315 BD Luer Slip Syringe Products (REF 301294, 301295, 30020) 2008/002/001/181/009 FSCA 2008/03/05

SN080316 Terumo Weighed Flexible Sucker (Ref Code 804113) 2008/002/020/061/003 FSCA 2008/03/05

SN080317 2008/002/021/291/008 FSCA 2008/03/05

SN080318 WMS Disposable Pen Torch W2137 (Batch Q01403, Q01408, Q01371) 2007/011/006/401/010 FSCA 2008/03/05

SN080319 Baush and Lomb ReNu Comfort Drops (Lot No 225747 and 225757) 2008/002/011/061/014 FSCA 2008/03/05

SN080320 Arjo Ambulift Hoist MDA/2008/010 MDA 2008/03/05

SN080321 Advanced Bionics Precision Implantable Pluse Generator Kit (Model No. SC-1110) Z-0960-2008 to Z-0961-2008 Class II 2008/03/06


Health Canada

Health Canada

Health Canada

Health Canada

Health Canada

Health Canada

Health Canada

Health Canada

Health Canada

Health Canada

Health Canada

Health Canada

Health Canada

Health Canada

MHRA

MHRA

Trinity Biotech Bartels Viral Respiratory Screening and Identification Kit (Prodcut Code B1029-86) MHRA

MHRA

MHRA

MHRA

FDA























SN080322 Z-0131-2008 Class II 2008/03/06

SN080323 TENET Medical Engineering Wrist Stabilization Kit Z-0577-2008 to Z-0579-2008 Class II 2008/03/06

SN080324 Z-0674-2008 Class II 2008/03/06

SN080325 Philips Medical Allura XPER FD10 and FD10/10 with AD7 2008/002/021/291/001 FSCA 2008/03/12

SN080326 VNS Therapy Demipulse Generator (103) and Demipulse Duo Generator (104) 2008/002/021/061/003 FSCA 2008/03/12

SN080327 2008/002/025/291/022 FSCA 2008/03/12

SN080328 Biomet Vanguard Width Checker (Item Number # 32-487062) 2008/002/019/061/010 FSCA 2008/03/12

SN080329 Z-0856-2008 to Z-0865-2008 Class II 2008/03/19

SN080330 Stryker Disposable StrykeProbe 32 cm L-Tip and Spatula Tip Z-0573-2008 to Z-0574-2008 Class II 2008/03/19

SN080331 Siemens ACUSON Aspen Diagnostic Ultrasound System (Model Number 8247887) Z-0719-2008 Class II 2008/03/19

SN080332 Zimmer Allofit Shell Size 50 (Model 4244, Lot 2406181) 39593 Type II 2008/03/19

SN080333 Zimmer Hemovac Infection Control Kits 40972 Type II 2008/03/19

SN080334 Siemens Syngo Dynamica (Model 100 90 679; Serial # 92241, 93477, 95243, 95248) 40885 Type II 2008/03/19

SN080335 Siemens Leonardo Workstation (Model 7129534, Serial # 10413, 10434, 10599) 40580 Type II 2008/03/19

SN080336 Abbott Clinical Chemistry Phenytoin (Model IE07-20) 41000 Type II 2008/03/19

SN080337 Siemens Dade Behring Complement Reagents (Model OWZD11; Lot# 542849) 39678 Type II 2008/03/19

SN080338 40881 Type II 2008/03/19

SN080339 Draeger Medical Fabius GS (Model# 8604700) 40720 Type II 2008/03/19

SN080340 Beckman Coulter IMMAGE C-Reactive Protein CRP Reagent (Model # 447280) 40898 Type II 2008/03/19

SN080341 VIASYS Microjack Patient Interface (Model # GP 320000-00) 40966 Type II 2008/03/19

SN080342 Cardinal Health Sterile Bowel Resection-Lithotomy Pack and Major Surgery Packs 40924 Type II 2008/03/19

SN080343 38920 Type II 2008/03/19

SN080344 Coopersurgical Mystic II Pump with M-Style Mushrooncup (Model no 10057) 40725 Type II 2008/03/19

SN080345 Computerized Medical Systems Focal Workstation 40151 Type II 2008/03/19

American Medical Systems, Inc., GreenLight HPS Fiber Optic (ADDStat) (Part Number: 0010-2090B) FDA

FDA

Orthofix TrueLok External Ring Fixation System, Telescopic Linear Distractor (Catalog No. 50-10185) FDA

MHRA

MHRA

Smiths Medical Logical, NovaTrans, and Transtar Invasive Pressure Monitoring Kits with Trigger Flush Device MHRA

MHRA

Zimmer Pulsavac Plus Wound Debridement System, Pulsavac Plus AC Component Kit, Pulsavac Fan Spray Kit and Hip Kit FDA

FDA

FDA

Health Canada

Health Canada

Health Canada

Health Canada

Health Canada

Health Canada

Boston Scientific Advanced Bionics Clinician's Programmer Navigation V1.02 (Model P/N 9055528-001, SC-7150) Health Canada

Health Canada

Health Canada

Health Canada

Health Canada

Johnson & Johnson, Ortho-Clinical Blood Grouping Reagent Anti-Le Bioclone (Model# 715280) Health Canada

Health Canada

Health Canada


























SN080346 Z-0186-2008 to Z-0191-2008 Class II 2008/03/25

SN080347 GE Healthcare Mobile Fluoroscopy X-Ray System OEC Model 7600 AND 7700 Z-0716-2008 to Z-0717-2008 Class II 2008/03/25

SN080348 Z-0933-2008 Class II 2008/03/25

SN080349 Smith & Nephew Exu-Dry Wound Burn Dressing Z-1199-2008 to Z-1217-2008 Class II 2008/03/25

SN080350 Z-1192-2008 to Z-1195-2008 Class II 2008/03/25

SN080351 Z-0455-2008 Class II 2008/03/25

SN080352 ALN IVC Filter (Lot: 0107A, 0207A, 0207B, 0307A & 0407A) 2007/012/012/401/002 FSCA 2008/03/25

SN080353 GE Heatlhcare Advantx-E, Innova 2000, 2100IQ, 3100/3100IQ AND 4100/4100IQ 2008/002/026/061/016 FSCA 2008/03/26

SN080354 ASTRA PEP/RMT Products (Prodtuct Ref 71001, 71002, 71006, 71007, 71042 and 71052) 2008/002/027/291/003 FSCA 2008/03/26

SN080355 Jenx Bee Chair 2008/002/001/301/001 FSCA 2008/03/26

SN080356 AKW 2000 Series Seats 2007/009/017/601/005 FSCA 2008/03/26

SN080357 Olympus AU2700 Clinical Chemistry Analyser (Models : ALL; Serial: ALL) 2008/003/003/291/003 FSCA 2008/03/26

SN080358 BIO-RAD ScanGel 2008/003/004/061/009 FSCA 2008/03/26

SN080359 Sidhil Millennium Freedom Bed (Product Code(s) 1262, 1263, 1263/LOW) 2007/010/031/061/007 FSCA 2008/03/26

SN080360 Arcomedical 3100-J (FSB499) Burette Set (Batch N1068) 2008/003/012/291/012 FSCA 2008/03/26

SN080361 Trulife Heel & Elbow and the Heel & Ankle Gelbodies MDA/2008/013 MDA 2008/03/26

SN080362 Etac Patient Turner (Model 411973300) MDA/2008/018 MDA 2008/03/26

SN080363 Medtronic LIFEPAK 1000 Medtronic International Ltd N/A Firm Initiated Field Action 2008/03/26

SN080364 Cryocath FlexCath Steerable Sheath(Ref 3FC12) Cryocath Technologies Inc. N/A Firm Initiated Field Action 2008/03/26

SN080365 American Medical Systems GreenLight HPS System (Part No. 0010-0070 and 0010-0075) Z-0130-2008 Class II 2008/03/27

SN080366 Gambro cartridge blood set with Phoenix Hemodialysis System Z-1367-2008 Class II 2008/03/27

SN080367 Z-1051-2008 to Z-1053-2008 Class II 2008/03/27

Allez Spine Size 8 Pedicle Screws (Catalo # LG-PR0835, LG-PR0840, LG-PR0845, LG-PR0850, LG-PR0855, LG-PR0880) FDA

FDA

Linemaster Wireless Footswitch Accessory (Model SP-9970214-005112010 and SP-9970214-005112232) FDA

FDA

Stryker VertePort 10G Access Cannula w/Long Stylet System, 10G Cement Cannula, 10G Access Canula (short) and 11 G Cement Cannula FDA

Abbott CELL-DYN 1800 System with CELL-DYN 22 Calibrators and the CELL-DYN Calibrators abd CELL-DYN 16 Controls (Part # 07H77-01) FDA

MHRA

MHRA

MHRA

MHRA

MHRA

MHRA

MHRA

MHRA

MHRA

MHRA

MHRA

FDA

FDA

Draeger TI500 Isolette Infant Incubator (Catalog no.: MU20505), GT500 Globe Trotter Transport System (Catalog no.: MU20508) and Globe Trotter IC (Catalog no.: MU20509) FDA






















SN080368 Smith & Nephew CALAXO Bioabsorbable Interference Screw Z-0593-2008 to Z-06161-2008 Class II 2008/03/27

SN080369 Z-1042-2008 to Z-1049-2008 Class II 2008/03/27

SN080370 Abbott Clinical Chemistry Creatine Kinase (Model LN 7D63-30) Z-1109-2008 Class II 2008/03/27

SN080371 Stryker Orthopaedics, UHR Universal Bipolar Component, Hip Prosthesis Component Z-0621-208 to Z-0656-2008 Class II 2008/03/27

SN080372 Stryker Orthopaedics Locking Screw T7 (Catalog no 40-27622) Z-1297-2008 Class II 2008/03/27

SN080373 Z-0571-2008 Class II 2008/03/27

SN080374 Bausch and Lomb Non-Sterile Multiple-use Phaco needles Bausch and Lomb N/A Firm Initiated Field Action 2008/03/27

SN080375 Boston Scientific COGNIS CRT-D device N/A Firm Initiated Field Action 2008/03/27

SN080376 Osypka Medical External Dual Chamber Pluse Generator PACE 203H 2008/002/022/401/004 FSCA 2008/03/28

SN080377 Volker Nursing Beds (Models 3010 and 5020) MDA/2008/020 MDA 2008/03/28

SN080378 Linet Hospital beds Eleganza Standard, Smart and Deluxe models MDA/2008/021 MDA 2008/03/28

SN080379 2008/002/026/291/005 MDA 2008/03/28

SN080380 Philips Brilliance CT Systems 39694 Type II 2008/03/31

SN080381 Philips Carevue Chart Release C v C.00.00-06 and Intellivue Clinical Info Portfolio D 41242 Type II 2008/03/31

SN080382 Steris Tenzor Carbon Fiber Orthopedic Traction 41089 Type II 2008/03/31

SN080383 Steris C1160 Tray used with Steris System 1 41078 Type II 2008/03/31

SN080384 Steris Amsco Remanufactured Prevacuum Sterilizers 41256 Type II 2008/03/31

SN080385 Smiths Medical Flo-2 kit With Mask 41199 Type II 2008/03/31

SN080386 Radiometer Medical ABL80'S With Software Version 1.10 38880 Type II 2008/03/31

SN080387 International Technidyne Corp Avoximeter 1000E Oximeter 41136 Type II 2008/03/31

SN080388 Maquet Jostra Heater-Cooler Unit 30 System 41072 Type II 2008/03/31

SN080389 Biosense Webster Navistar RMT Diagnostic/Ablation Catheter 41193 Type II 2008/03/31

SN080390 Popper And Sons Perfektum Toomey Evacuating Syringe 40097 Type II 2008/03/31

FDA

Siemens Magnetom Harmony Mobile MRI System, Magnetom Harmony syngo , Magenetom Symphony Magnetom Sonata syngo and Magnetom Symphony syngo FDA

FDA

FDA

FDA

Ventana Image Analysis Ssystem (VIAS) PATHWAY anti-HER-2/neu (4B5) primary antibody with software version 2.3.0.2 (Model no. VIAS-799-10000-00) FDA


MHRA

MHRA

MHRA

Smiths Medical CADD-MS 3 Ambulatory Infusion Pump (Model 7400, Recorder No 21-7401-54 and 21-7411-51) MHRA

Health Canada

Health Canada

Health Canada

Health Canada

Health Canada

Health Canada

Health Canada

Health Canada

Health Canada

Health Canada

Health Canada























SN080391 Tomotherapy Hi-Art System 41091 Type II 2008/03/31Health Canada



Local Agent

N/A N/A

N/A N/A


N/A N/A

N/A N/A



N/A N/A

N/A N/A

N/A N/A


B. Braun Medical (HK) Ltd 2277 6611

N/A N/A

N/A N/A

BD 2518 6988


N/A N/A

N/A N/A


N/A N/A

N/A N/A



N/A N/A

N/A N/A

N/A N/A


N/A N/A

N/A N/A

N/A N/A












Beckman Coulter Hong Kong Ltd. 2240 6260

VIASYS Healthcare (Hong Kong) Ltd 6305 5575

N/A N/A


N/A N/A

N/A N/A


N/A N/A


N/A N/A




N/A N/A


N/A N/A

N/A N/A

N/A N/A

Olympus Hong Kong Ltd 2376 1805


N/A N/A

N/A N/A

N/A N/A

N/A N/A


Cryocath Technologies Inc. N/A

N/A N/A









N/A N/A



N/A N/A

N/A N/A

N/A N/A







N/A N/A

N/A N/A

N/A N/A

Maquet Hong Kong Ltd N/A

N/A N/A

N/A N/A


TomoKnife (Hong Kong) Ltd 2609 0974


Monthly Summary of Medical Device Safety Alerts -February 2008*Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada


SA080201 Z-0675-2008 Class II 01-Feb-08

SA080202 Fertility Technology Resources Tucker Embryo Catheter and Morton IUI Catheter Z-0662-2008 to Z-0667-2008 Class II 01-Feb-08

SA080203 Hoana LifeBed Patient Vigilance System (Model# 010135-01) Z-0592-2008 Class II 01-Feb-08

SA080204 AADCO Rayshield Frame Mounted Overhead X-Ray Barrier Z-0552-2008 Class II 01-Feb-08

SA080205 VNUS 7F ClosureFAST Catheter (Order# CF7-7-60 and CIF7-7-100) Z-0542-2008 to Z-0543-2008 Class II 01-Feb-08

SA080206 Z-0537-2008 to Z-0541-2008 Class II 01-Feb-08

SA080207 Intuitive Surgical EndoWrist (Part # 400214-02, 400214-03, 420214-02 and 420214-03) Z-0258-2008 Class II 01-Feb-08

SA080208 AmniSure ROM Test (Model # FMRT-1) Z-0120-2008 Class II 01-Feb-08

SA080209 Biomet Straight Magnum Inserter Handle (REF# or Catalo # S313141) Z-0115-2008 Class II 01-Feb-08


SA080211 Abbott Accelerator Device Manager (ADM) (List # 08H74-01) Z-0551-2008 Class II 01-Feb-08

SA080212 Abbott AxSYM AUSAB Reagent Pack (List no.: 3C74-20) Z-0127-2008 Class II 01-Feb-08

SA080213 Superior Oxy Serve II Oxygen Conserving Regulator (Model # MCRB-870-6) Z-0529-2008 Class II 01-Feb-08

SA080214 Toshiba Aquilion 32, 64, Super 4 and Toshiba 256-Slice Scanner 40047 Type II 04-Feb-08

SA080215 Philips Brilliance Big Bore CT Scanners using software v2.2.1 through v2.2.5 2008/001/024/291/004 FSCA 04-Feb-08

SA080216 Abbott AxSYM Drugs of Abuse/Toxicology Assay Disk Version 8.0 (List # 3D54-08) 2008/001/024/601/003 FSCA 04-Feb-08

SA080217 Stryker Burs 2008/001/014/291/020 FSCA 04-Feb-08

SA080218 2008/001/021/601/002 FSCA 04-Feb-08

SA080219 Roche COBAS AmpliPrep/ COBAS Taqman & High Pure System/COBAS Taqman 48 2007/011/019/291/011 FSCA 04-Feb-08


Organogenesis Apligraf, interactive wound and burn dressing (Lot # GS0711.20.01.2A and GS0711.22.01.2A) FDA

FDA

FDA

FDA

FDA

Ventana Benchmark, Benchmark XT, Benchmark LT, Discovery and Discovery XT Slide Staining System FDA

FDA

FDA

FDA

Johnson and Johnson Depuy TK2 Compression Hip Screw Trauma Plate (REF 8315-35-004, 8315-35-104) FDA

FDA

FDA

FDA

Health Canada

MHRA

MHRA

MHRA

Siemens Urea Nitrogen (BUN) Flex reagent cartridge (DF21) (Lot no. FC8283 and FH8271) MHRA

MHRA















http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2033926&ssTargetNodeId=967






SA080220 Corin Cormet Head Trial Size 4/44 2008/001/023/291/002 FSCA 04-Feb-08

SA080221 Stryker Trident PSL and Hemispherical Acetabular Cups Stryker China Ltd N/A Firm Initiated Field Action 04-Feb-08

SA080222 Respironics Esprit ventilators CELKI Medical Company N/A Firm Initiated Field Action 06-Feb-08


SA080224 Intuitive Surgical da Vinci S Surgical System 5 mm instrument cannula (Part#:420011-01) Z-0669-2008 Class II 11-Feb-08



SA080227 Philips Page Writer Touch Cardiograph (Model # 860284) Z-0124-2008 Class II 11-Feb-08

SA080228 GE Innova 2100IQ, 3100/3100IQ and 4100/4100IQ Z-0690-2008 to Z-0692-2008 Class II 11-Feb-08

SA080229 Blackstone Hallmark Anterior Cervical Plate System (REF#62-3140) Z-0478-2008 Class II 11-Feb-08

SA080230 Biomet CC Cruciate Tibial Tray (Product no 141232, 141234) Z-0706-2008 to Z-070-2008 Class II 11-Feb-08

SA080231 Spacelabs Medical, Ultraview Multigas Anaylzer (Model 91518) Z-0660-2008 Class II 11-Feb-08

SA080232 Molnycke Health Care Laparoscopic Cholecysectomy 2008/001/031/291/002 FSCA 12-Feb-08

SA080233 Schiller FRED Easy Defibrillator 2008/001/024/291/003 FSCA 12-Feb-08

SA080234 Days Healthcare Viper & Viper Plus Powerchairs 2008/001/022/301/002 FSCA 13-Feb-08

SA080235 Arkray Assure 3 Blood Glucose Test Strips (PRODUCT NO 555050) Z-0699-2008 Class II 18-Feb-08


SA080237 Inotech Brand Heparin Adsobent (Catalog# HA-1) Z-0934-2008 Class II 18-Feb-08

SA080238 Horizon Cardiology Hemo Monitoring System Z-0710-2008 Class II 18-Feb-08

SA080239 Z-0738-2008 Class II 18-Feb-08

SA080240 Cook THSCF-35-260-3-AUS2 Z-0135-2008 Class II 18-Feb-08


SA080242 Medtronic Cardioblate Gemini-s model 49260 Z-0727-2008 Class II 18-Feb-08

SA080243 Siemens Dade Behring BEP III System 2008/002/005/061/014 FSCA 20-Feb-08

MHRA

Intuitive Surgical da Vinci S Surgical System 8mm instrument cannula, 8mm Long instrument cannula and 5 mm instrument cannula (Part#:420002-01. 420004-01 and 420011-01)

FDA

FDA

Baxter RenalSoft v.2.0 Patient Management Software Suite - HD Module and Baxter Renal Software Suite v3.0 and v3.1 - Renal Link HD Module FDA

Philips Gemini 16 and 64-slice PET/CT Systems, Gemini GXL 6, 10 and 16 slice PET/CT Systems FDA

FDA

FDA

FDA

FDA

FDA

MHRA

MHRA

MHRA

FDA

Biomet Ringloc Instrumentation Impactor Plate (Ref/Part # 31-400620 - 31-400623, 31-400626, 31-400628) FDA

FDA

FDA

Fresenius Medical Care Optiflux 180NR Advanced Fresenius Polysulfone (Catalog no. 0500318E) FDA

FDA

Medtronic Kyphon Functional Anesthetic Discography (F.A.D.) Catheter System (Catlog # D014, D01B) FDA

FDA

MHRA
























SA080244 Care & Independence Systems InChair Sling 2007/004/030/261/002 FSCA 20-Feb-08

SA080245 GE Healthcare InstaTrak 3500 Plus with the Cranial Application for Image Guide Surgery 2008/002/011/061/008 FSCA 21-Feb-08

SA080246 GE Healthcare Clinical Information Centre (CIC) Pro v5.0.3 and 5.0.6 2008/002/006/601/033 FSCA 21-Feb-08

SA080247 Abbott Comfort T-handle Hudson Connector with Impactor Cap (Part # 1006-1) Z-0880-2008 Class II 22-Feb-08

SA080248 Siemens Mevatron KD2 Medical Charged-Particle Radiation Therapy System Z-0677-2008 to Z-0687-2008 Class II 22-Feb-08

SA080249 Roche LIPC Lipase Colorimetric Reagent (Catalog No.: 03029590322) Z-0688-2008 Class II 22-Feb-08

SA080250 Z-0718-2008 Class II 22-Feb-08

SA080251 Z-0718-2008 Class II 22-Feb-08


SA080253 ConMed Electrosurgical blades and Needles 2008/002/011/061/011 FSCA 22-Feb-08

SA080254 Unipath SmartCheck INR POC Meter and Consumables 2008/002/020/061/008 FSCA 22-Feb-08

SA080255 Roche Accu-Chek inform Base Unit Serial Number - UJ33XXXXXX 2008/002/006/291/001 FSCA 22-Feb-08

SA080256 Philips General X-Ray System 2008/002/012/061/007 FSCA 22-Feb-08

SA080257 Philips X-Ray System Types Omni Diagnost Eleva 2008/002/013/061/004 FSCA 22-Feb-08

SA080258 N/A Press Release 26-Feb-08

SA080259 2008/002/012/061/008 FSCA 27-Feb-08

SA080260 Medtronic Internal Defrillation Handles and Electrodes 2008/002/015/061/001 FSCA 27-Feb-08

SA080261 2008/002/014/601/063 FSCA 27-Feb-08

SA080262 Bausch and Lomb Stellaris Vision Enhancement System Bausch and Lomb N/A Firm Initiated Field Action 27-Feb-08

SA080263 N/A Press Release 29-Feb-08

SA080264 Siemens Primus Linear Accelerator System and Mevatron Linear Accelerator Systems Z-0850-2008 to Z-0852-2008 Class II 29-Feb-08

SA080265 Siemens Syngo Imaging System with VB30A version of software (Model No. 10014063) Z-0732-2008 Class II 29-Feb-08

SA080266 Kodak DirectView Model DR 3000 System, Stationary X-Ray System Z-0731-2008 Class II 29-Feb-08

SA080267 Hill-Rom Avantguard 1200 and 1400 with manually operated lock-out function MDA/2008/008 MDA 29-Feb-08

MHRA

MHRA

MHRA

FDA

FDA

FDA

Varian VARiS 1.4g; Linear Accelerator with RTP Exchange v6.2, v6.6 and v8.0 (Models : ALL) FDA

Hamilton Sample Carriers for the ML STAR line (SMP-CAR-24) (Product Code: 866.2500; Part No. 173400) FDA

Rockwell Medical RenalPure Liquid Acid Concentrate R-006, R-235 and R-259 ; Glacial Acidic Acid and Dri-Sate Glacial Acidic Acid FDA

MHRA

MHRA

MHRA

MHRA

MHRA

Chattem Icy Hot Heat Therapy Air Activated Heat adhesive heating patch - (i) Back; (ii) Arm, Neck, and Leg FDA

Philips Easy Diagnost Eleva family, Easy Diagnost Classic family and Diagnost 76 plus family MHRA

MHRA

Baxa Corporation EM4200 Exacta-Mix Compounder Operating Software V1.05, 1.06 & 1.06.1 MHRA

Baxter Heparin Sodium Injection multi-dose, single dose vials and HEP-LOCK heparine flush products (lots: ALL) FDA

FDA

FDA

FDA

MHRA















http://www.fda.gov/oc/po/firmrecalls/chattem02_08.html




http://www.fda.gov/oc/po/firmrecalls/baxter02_08.html






SA080268 Hill-Rom Affinity Birthing Bed (Model P3600, P3700A, P3700B) Z-0581-2008 to Z-0584-2008 Class II 29-Feb-08

SA080269 Z-0079-2008 Class II 29-Feb-08


SA080271 Nova EZ CHEM Creatinine Meter, Control Solution and Linearity Solution Z-0724-2008 to Z-0726-2008 Class II 29-Feb-08

SA080272 Philips Digital Diagnost Family 2008/002/019/063/003 FSCA 29-Feb-08

SA080273 Philips EasyVision RAD 2008/002/020/061/007 FSCA 29-Feb-08

SA080274 Stryker Gamma 3 Set Screwdriver, 4mm Flexible Shaft (Catalog No 1320-0231) 2008/002/006/061/001 FSCA 29-Feb-08

SA080275 Philips Digital Diagnost family, Bucky Diagnost family, Easy Diagnost family, Thoravision 2008/002/019/061/020 FSCA 29-Feb-08

SA080276 Depuy polyethylene knee bearings 2007/010/031/061/010 FSCA 29-Feb-08

FDA

Intuitive Surgical daVinci S Surgical System (Model No. IS2000) and Surgical Endoscopic Instrument Control System (Model No IS2000) FDA

Intuitive Surgical daVinci S Surgical System, Endoscopic Instrument Control System (Model No IS2000) with Isolation Transformer and Vision Cart (Model VS1000 and VS2000)

FDA

FDA

MHRA

MHRA

MHRA

MHRA

MHRA











Local Agent

N/A N/A

N/A N/A

N/A N/A

N/A N/A

N/A N/A

N/A N/A

N/A N/A

N/A N/A





N/A N/A

Sanko Medical System (HK) Ltd 2384 0688








N/A N/A



N/A N/A

N/A N/A





N/A N/A

N/A N/A

N/A N/A

N/A N/A


N/A N/A

N/A N/A


N/A N/A

N/A N/A

Fresenius Medical Care Asia-Pacific Ltd. 2802 2900

Medtronic International, Ltd. 886-22183-6130



(1) Cook Asia (Hong Kong) Ltd.; (2) A.R. Burkhill & Sons (Hong Kong) Ltd.

(1) 2781 0232; (2) 2541 1041


N/A N/A







N/A N/A

N/A N/A

N/A N/A

N/A N/A




N/A N/A



N/A N/A





Carestream Health Hong Kong Limited 2564 9759

N/A N/A


N/A N/A

Chindex 2892 0301

N/A N/A

N/A N/A







Monthly Summary of Medical Device Safety Alerts -January 2008*Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada


SA080101 Medtronic CD Horizon Agile Dynamic Stabilization Device 2007/011/013/061/020 FSCA 2008/01/02

SA080102 Smiths Medical Graseby 500 and 505 volumetric infusion pumps (Models: ALL) MDA/2007/100 MDA 2008/01/02

SA080103 Z-0192-2008 to Z-0210-2008 Class II 2008/01/03

SA080104 Z-0377-2008 to Z-0379-2008 Class II 2008/01/03

SA080105 Z-0149-2008 Class II 2008/01/03

SA080106 Z-0148-2008 Class II 2008/01/03

SA080107 Z-0153-2008 to Z-0154-2008 Class II 2008/01/03

SA080108 Microbiologics P.vulgaris, DuoPacksI (Product Catalog # 0691P, ARCC 0427; Exp 2008-9) Z-0456-2008 Class II 2008/01/03

SA080109 BatteryZone Life+cel (OEM P/N 9146-001 and 9141-001 ; Part # 7L877 and 2L561) Z-0523-2008 to Z-0524-2008 Class II 2008/01/03

SA080110 2007/012/006/061/016 FSCA 2008/01/07

SA080111 Philips Digital Diagnost Family 2007/009/006/401/002 FSCA 2008/01/07

SA080112 ThermoFisher Scientific DADE Cardiac TL Assayed Cardiac Marker Control 2007/012/018/051/002 FSCA 2008/01/07

SA080113 Horcher Lifting System Powered Patient Positioner 2007/007/010/401/004 FSCA 2008/01/07

SA080114 2007/008/006/401/005 FSCA 2008/01/07

SA080115 2007/012/018/051/001 FSCA 2008/01/09

SA080116 ProTime Microcoagulation System PROTIMEINT 2007/011/028/291/005 FSCA 2008/01/09

SA080117 Stryker Distal Depth Screw Guage (Catalog. no. 12146000, LOT/BATCH NO:K532495) 2007/011/027/061/012 FSCA 2008/01/09

SA080118 Stryker Stretchers (Model No.: 660, 721, 735, 1001, 1002, 1005, 1015, 1020, 1069) 2007/012/013/061/010 FSCA 2008/01/09

SA080119 Fresenius Medical Care multiFiltrate acute dialysis system 2007/012/017/051/003 FSCA 2008/01/09

SA080120 BD 5ml and 10ml Syringe Luer Lok Tip, Bulk, Sterile Convenience Paks BD N/A Firm Initiated Field Action 2008/01/09

SA080121 bioMerieux, BacT/ALERT FA Culture Bottles (Lot no 1017685, 101793 and 1017788) Z-0457-2008 Class II 2008/01/11


MHRA

MHRA

Medtronic Satellite Spinal System, Satellite Sphere CoCr, Satellite System Sphere PEEK and Material Stainless Steel/Radel FDA

Roche Ammonia/Ethanol/CO2 Calibrator, Control N (Normal) and Control A (Abnormal) (Catalog no. 20751995190, 20752401190, 20753009190) FDA

Rita Medical Vortex VX Port System (REF/Part no.: P5455K; Catalog No.: P5455, Latex Free, Sterile) FDA

Ellex Eye Cubed, I 3 System-ABD Ultrasound Version 3.0 with Software Version 3.0 and Biometry A-Scan modality FDA

Precept Medical Products Tape Fog Shield Surgical Mask Green Fiberglass Free and Foam Fog Shield Surgical Mask Green Fiberglass Free (Reorder#65-3322 and 65-3320) FDA

FDA

FDA

Hill-Rom SM647 Medical Charis and SM608 Relaxation Chairs (Serial no HRP000698167 - HRP000733692) MHRA

MHRA

MHRA

MHRA

Select Healthcare DUO Transfer Slide Deluxe and Duo Transfer Slide (Model LOCO-400A and LOCO-410A) MHRA

Smiths Medical CADD Medication Cassette Reservoirs (Recorder No.: 21-7002-24, 21-7001-24, 21-7100-24) MHRA

MHRA

MHRA

MHRA

MHRA

FDA






















SA080122 Abbott CELL-DYN Sapphire Hemoglobin Reagent Analyzer Syringes (List no 08H49-02) Z-0301-2008 Class II 2008/01/11

SA080123 Siemens IMMULITE/IMMULITE 1000, IMMULITE 2000 and IMMULITE 2500 Operators 2008/001/004/601/001 FSCA 2008/01/14

SA080124 Siemens Syva Emit II Plus Amphetamines Assay (Catalog No 9C039ul, Lot Z10) 2008/001/003/601/002 FSCA 2008/01/14

SA080125 Smith & Nephew Wrist Stabilization Kit (Part # 7691, 7692, 7693 ; Lot # 20060605) 2007/012/020/061/001 FSCA 2008/01/14

SA080126 Fresenius Kabi Orchestra Base Primea 2008/001/007/061/010 FSCA 2008/01/14

SA080127 AMO VISX STAR excimer laser chair 2008/001/004/061/010 FSCA 2008/01/14

SA080128 Stephan Neonatel Transport Ventilator 2007/012/007/061/002 FSCA 2008/01/15

SA080129 BD FACSDiva software v6.0 and 6.1 with the HP XW4400 Computer System 2008/001/008/061/012 FSCA 2008/01/15

SA080130 Fannin GU Fibrillator Unit 3821 2008/001/009/291/003 FSCA 2008/01/15

SA080131 Datascope CS 100 Intro-Aortic Balloon Pump and CS 300 Intra-Aortic Balloon Pump 2008/001/009/291/002 FSCA 2008/01/15

SA080132 Boston Scientific Stainless Steel Greenfield Vena Cava Filter N/A Firm Initiated Field Action 2008/01/16

SA080133 Boston Scientific Slimline 200 Micron Delivery System N/A Firm Initiated Field Action 2008/01/16

SA080134 Boston Scientific Galaxy 2 and ClearView Systems N/A Firm Initiated Field Action 2008/01/16

SA080135 N/A Firm Initiated Field Action 2008/01/16

SA080136 Siemens Biograph 6, 16, 40-3 Ring, 40 TruePoint, 64-3 Ring and DUO LSO Z-0247-2008 to Z-0252-2008 Class II 2008/01/16

SA080137 Johnson and Johnson CORDIS FireStar and Dura Star RX PTCA Dilatation Catheters N/A Firm Initiated Field Action 2008/01/16

SA080138 Abbott ARCHITECT i System Assay CD-ROM-WW (List No. (LN) 6E59) Z-0299-2008 Class II 2008/01/17

SA080139 Z-0300-2008 Class II 2008/01/17

SA080140 Z-0305-2008 Class II 2008/01/17

SA080141 Encore Medical VariLift Bone Plug w/ End Cup Z-0306-2008 to Z-0311-2008 Class II 2008/01/17

SA080142 Siemens ACUSON Antares, Ultrasound System Z-0297-2008 to Z-0298-2008 Class II 2008/01/17

SA080143 Oasis Medical PremierEdge MICROSURGICAL KNIFE Z-0485-2008 to Z-0516-2008 Class II 2008/01/17

SA080144 Fisher and Paykel Healthcare Cosycot UPS 2007/005/010/401/004 FSCA 2008/01/17

SA080145 Siemens ADVIA Centaur and ADVIA Centaur XP Immunoassay Systems 2008/001/003/291/003 FSCA 2008/01/17

SA080146 VacSax and GelSax Disposable Suction Liners 2007/011/023/401/002 FSCA 2008/01/17

FDA

MHRA

MHRA

MHRA

MHRA

MHRA

MHRA

MHRA

MHRA

MHRA




Boston Scientific ICD and CRT-D devices implanted subpectorally with the serial number facing the ribs


FDA


FDA

Ventena Medical System's Symphony Staining System, KPA (Model # : 2200000; catalog# 900-SYM1 and 900-SYM3) FDA

Toshiba Aplio XG Diagnostic Ultrasound System (Model: SSA-790A with version 1.1 software) FDA

FDA

FDA

FDA

MHRA

MHRA

MHRA






















SA080147 39272 Type II 2008/01/18

SA080148 Baxter Healthcare Infusor 2mL/HR 39388 Type II 2008/01/18

SA080149 BD difco Shigella antiserum poly groupb 39695 Type II 2008/01/18

SA080150 39405 Type II 2008/01/18

SA080151 BD Calibrite APC Beads (Model # 340487) 39352 Type II 2008/01/18

SA080152 Philips Medical Allura XPER FD20 System (S/N 297) 39575 Type II 2008/01/18

SA080153 Philips Medical BV Endura and BV Pulsera (Model# MMC 2011, MMC 2011) 39582 Type II 2008/01/18

SA080154 Varian RPM Respiratory Gating System 39358 Type II 2008/01/18

SA080155 39425 Type II 2008/01/18

SA080156 Bio-Rad Amplicheck Swab CT/GC Control A positif (Model # 133, 133X) 39423 Type II 2008/01/18

SA080157 Cardinal Health Medley Pump Module (Model 8100LVP) 39408 Type II 2008/01/18

SA080158 Henry Schien Mirror Defogger (Model# 1000459, 17-20902) 39386 Type II 2008/01/18

SA080159 M.C. Healthcare Maxxum Hi/Lo Bed 39652 Type II 2008/01/18

SA080160 BHM Medical 1000LB Scale, 300KG,Class 3 Scales, 800 LB Scale, Ergolift with Scale 39427 Type II 2008/01/18

SA080161 St. Jude Medical Epic, Atlas and Convert Family of ICDs St. Jude Medical N/A Firm Initiated Field Action 2008/01/18

SA080162 Smith & Nephew Universal Hip Extractors (Part No. 72200626) 2008/001/004/061/003 FSCA 2008/01/21

SA080163 2008/001/011/061/026 FSCA 2008/01/21

SA080164 Abbott CELL-DYN 4000 and CELL-DYN Sapphire WBC Reagent (Part A, List # 01H77-01) 2007/012/024/601/003 FSCA 2008/01/21

SA080165 Datascope Panorama Patient Monitoring Network, Panorma Telepack 608 Z-0150-2008 Class II 2008/01/24

SA080166 Sechrist Hyperbaric Chanmber Curney Z-0733-2008 to Z-0737-2008 Class II 2008/01/24

SA080167 Siemens ADVIA Centaur and ADVIA Centaur XP Immunoassay Systems 2008/001/017/291/012 FSCA 2008/01/24

SA080168 Alcon Ophthalmic Procedure Pack 2008/001/004/061/006 FSCA 2008/01/24

SA080169 Wescor Osmocoll SS-025, SS-038 and SS-039 2008/001/017/291/013 FSCA 2008/01/24

SA080170 Medtronic Synchromed EL, Synchromed II and IsoMed drug infusion pumps Medtronic International Ltd N/A Firm Initiated Field Action 2008/01/24

SA080171 ev3 IntraStent Unmounted Balloon Expandable Stents 2008/001/011/291/003 FSCA 2008/01/28

SA080172 Chattanooga Electrotherapy Devices (Intelect and Vectra Series) 2007/012/020/061/019 FSCA 2008/01/28

SA080173 Lombard Medical Aorfix Stent Grafts 2008/001/017/291/011 FSCA 2008/01/28

Baxter Healthcare Home Choice Automated PD System and Home Choice Pro Automated PD System Health Canada

Health Canada

Health Canada

BD vacutainer push button blood collection sets with pre-attached holder (Model# 367352, 368656) Health Canada

Health Canada

Health Canada

Health Canada

Health Canada

Roche Diagnostics Coagucheck XS PT strips 2x24, 24,6 tests (Model#4625315017, 4625358017, 4625374190) Health Canada

Health Canada

Health Canada

Health Canada

Health Canada

Health Canada

MHRA

Philips M3170 IntelliVue Patient Link running software versions J.00.23, J.00.24, J.00.25 and J.00.26 MHRA

MHRA

FDA

FDA

MHRA

MHRA

MHRA

MHRA

MHRA

MHRA

http://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/list/rec-ret_md-im_date_jan-march_2008_e.html


























SA080174 Dixons Tudor Edwards Double Rib 2008/001/017/601/001 FSCA 2008/01/28

SA080175 Cyberonics VNS Therapy Lead Model 302 2008/001/002/061/002 FSCA 2008/01/28

SA080176 BD FACS Sample Prep Assistant II instruments 2007/010/002/061/013 FSCA 2008/01/28

SA080177 Stryker V40 Femoral Heads 2008/001/016/121/001 FSCA 2008/01/30

SA080178 Johnson and Johnson STERRAD Sterilizer System (50, 100S, 200 and NX Sterilizers) 2007/012/004/061/009 FSCA 2008/01/30

SA080179 Medtronic Model 8870 N'Vision Clinican Programmer Software Application Card 2008/001/003/291/014 FSCA 2008/01/30

SA080180 Biosite Triage Micro C. Difficile Panel (Catalog no 96000) 2008/001/017/291/003 FSCA 2008/01/30

SA080181 N/A Class I/Press Release 2008/01/31

MHRA

MHRA

MHRA

MHRA

MHRA

MHRA

MHRA

AM2 PAT Inc Pre-Filled Heparin Lock Flush Syringes and Normal Saline IV Flush Syringes (All Lots and All Sizes) FDA










Local Agent


Smiths Medical (S.E. Asia) Ltd. N/A



N/A N/A

N/A N/A

N/A N/A

N/A N/A

N/A N/A

N/A N/A


N/A N/A

N/A N/A

N/A N/A


N/A N/A



Fresenius Medical Care Asia Pacific Ltd. N/A

BD 2575 8668







Smith & Nephew Healthcare Ltd.2645 8703

N/A N/A

THI Holdings Inc.

N/A N/A

BD 2575 8668

N/A N/A

Datascope Corp Asia-Pacific 2647 9713








N/A N/A

N/A N/A

N/A N/A


N/A N/A

Tokibo Co. (HK) Ltd. 2418 9698


Goodwin Health Care Ltd 2408 8838




BD 2575 8668

BD 2575 8668

BD 2575 8668






N/A N/A

N/A N/A

N/A N/A

N/A N/A

St. Jude Medical N/A

Smith & Nephew Ltd. N/A



Datascope Corp Asia-Pacific 2647 9713

N/A N/A



N/A N/A


Conmed Limited 2854 4413

N/A N/A

N/A N/A


N/A N/A

GM Medical N/A

BD 2575 8668




N/A N/A

N/A N/A


Monthly Summary of Medical Device Safety Alerts -December 2007*Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada


SA071201 Medtronic International, Ltd. N/A Firm Initiated Field Action 2007/12/03

SA071202 Philips Brilliance or MX8000Dual v.EXP CT Couch 2007/010/029/061/017 FSCA 2007/12/04

SA071203 Vital PET/CT Visualization option available in ViTALConnect Version 4.0 and 4.1 2007/011/022/061/010 FSCA 2007/12/04

SA071204 ZOLL LifeVest WCD3000 Battery Pack 2007/011/026/061/018 FSCA 2007/12/04

SA071205 Draeger Medical Anaesthetic Gas Scaverging System (AGSS) receiver MDA/2007/090 MDA 2007/12/05

SA071206 Procare Privac set (Product code 24760) MDA/2007/091 MDA 2007/12/05

SA071207 Stryker V40+ 16mm Offset Femoral Heads and associated Femoral Head Trails 2007/011/026/061/011 FSCA 2007/12/06

SA071208 Baxter HomeChoice and HomeChoice PRO Automated Peritoneal Dialysis System 2007/011/030/061/012 FSCA 2007/12/06

SA071209 Ohio Willow Wood Alpha Original Locking Liners (ALL-X0XX / ALL-X1XX / ALL-X2XX) 2007/008/013/051/014 FSCA 2007/12/06

SA071210 Steering Developments Lifestyle JW1, JWII and JWX1 Wheelchair Power Assist System 2007/006/022/261/001 FSCA 2007/12/06

SA071211 VIASYS Infant Flow SiPAP Paediatric Respiratory Support Device MDA/2007/093 MDA 2007/12/07

SA071212 MI Tech Hanarostent Anti Reflux and Choostent 2007/008/014/061/009 FSCA 2007/12/07

SA071213 Sunrise Medical Little Gem 2 2007/011/016/301/002 FSCA 2007/12/07

SA071214 Movingpeople.net Beatle Y.e.S. 2007/005/003/401/001 FSCA 2007/12/07

SA071215 Philips MD Eleva Flat Detector (Ref XDB087-070515/BW) 2007/011/030/061/010 FSCA 2007/12/07

SA071216 Stryker UHR Universal Head Bipolar Component 2007/011/027/061/002 FSCA 2007/12/07

SA071217 Terumo Integrated Centrifugal System Control Unit (Model 801046, Lot: 0049, 0079) 38444 Type II 2007/12/10

SA071218 Terumo Ultrasonic Air Sensor (Model: 5773, 5785, 5791) 39116 Type II 2007/12/10

SA071219 Philips M3170 Intellivue Patient Link (Model: M3170, LOT: S/A 4721A01711) 38975 Type II 2007/12/10

SA071220 Smith & Nephew Genesis II femoral sets 39055 Type II 2007/12/10

SA071221 38472 Type II 2007/12/10

SA071222 Abbott AxSYM Gentamicin and TDx/TDxFLx Gentamicin (Model 7A65-20 and 9512-60) 38915 Type II 2007/12/10

SA071223 38840 Type II 2007/12/10

SA071224 Sigma 8002 Dual Channel Infusion Pump (Model 35061) 37977 Type II 2007/12/10

SA071225 Toshiba Asteion M/S4, Asteion S/S (Mode TSX-021A) 38921 Type II 2007/12/10


Medtronic Bravo pH capsule with delivery system (Proudct Numbers 9012B1011 and 9012B1001)

MHRA

MHRA

MHRA

MHRA

MHRA

MHRA

MHRA

MHRA

MHRA

MHRA

MHRA

MHRA

MHRA

MHRA

MHRA

Health Canada

Health Canada

Health Canada

Health Canada

Depuy PFC Sigma Knee System - ALL Polyethlen, PS RP Bearing, Stabilized TIBI and Preservation Unicondylar Knee -ALL POL Health Canada

Health Canada

Radiometer Pump tubes for ABL800 Series (Model: 842-326, 842-327, 842-328, 902-754, 905-671) Health Canada

Health Canada

Health Canada
















http://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/list/rec-ret_md-im_date_oct-dec_2007_e.html










SA071226 Toshiba-Interventional Angiography System, Infinix i (Model DFP-8000D) Z-0293-2008 Class II 2007/12/10

SA071227 Medtronic 0-arm Imaging System (Product Code B1-700-00027) Z-0294-2008 Class II 2007/12/10

SA071228 Z-0275-2008 to Z-0276-2008 Class II 2007/12/10

SA071229 Z-0179-2008 Class II 2007/12/10

SA071230 Z-0266-2008 to Z-0268-2008 Class II 2007/12/10

SA071231 Wright Medical Technology Odyssey Femoral Holder/Driver (Part no. K001-7410) Z-0290-2008 Class II 2007/12/10

SA071232 Xoran MiniCAT for ENT Z-0296-2008 Class II 2007/12/10

SA071233 Z-0177-2008 to Z-0178-2008 Class II 2007/12/10

SA071234 Sunrise Medical Sapphire 2 and Sapphire LS 2 FSCA 2007/12/11

SA071235 Philips Cardiac Viewer and Pulmonary Viewer Application 2007/011/030/061/009 FSCA 2007/12/12

SA071236 Henry Schein EasyCam Eurolite, Eurolite II and Eurodoc Intra-oral Cameras 2007/011/022/601/005 FSCA 2007/12/14

SA071237 2007/010/001/291/003 FSCA 2007/12/14

SA071238 Roche Elecsys HBsAgII and Elecsys Anti-HBs 2007/011/008/291/006 FSCA 2007/12/14

SA071239 Z-0380-2008 to Z-0384-2008 Class II 2007/12/14

SA071240 Biomet Orthopedics Vanguard PS Open Femoral (Ref. no.: 183130; Lot no. 395450) Z-0123-2008 Class II 2007/12/14

SA071241 Straumann Palatal Implant (Article No. 042.335S and 042.336S) Z-0277-2008 to Z-0278-2008 Class II 2007/12/14

SA071242 Frenius Kabi Applix Smart pump (all models) MDA/2007/098 MDA 2007/12/18

SA071243 2007/012/005/061/022 FSCA 2007/12/19

SA071244 Sysmex SF-3000 Haematology Analyser, software version 00-01 on CPSU-4 sampler 2007/011/005/401/011 FSCA 2007/12/19

SA071245 Radiometer Medical ABL77 Cal Packs 2007/009/003/061/009 FSCA 2007/12/19

SA071246 Stryker Hipstar V40 Femoral Stem-127 degrees (Cat. No. 7850-5-001 - 7850-5-012) Z-0463-2008 to Z-0474-2008 Class II 2007/12/20

SA071247 Stryker Hipstar TMZF Cementless Hip Stem Protocol (Product no. LSP60) Z-0475-2008 Class II 2007/12/20

SA071248 Z-0448-2008 to Z-0450-2008 Class II 2007/12/20

SA071249 Z-0356-2008 to Z-0357-2008 Class II 2007/12/20

SA071250 B. Braun Excia Cemented Hip Stems (Size 9mm to 18mm) Z-0436-2008 to Z-0445-2008 Class II 2007/12/20

FDA

FDA

Zimmer Durom Hip Resurfacing Systems, Femoral Component 54 Code T and 46 Code L (Cat no. 01.00211.154 and 01.00211.146) FDA

Edwards Lifesciences LifeStent FlexStar Bilary Stent System Application (Model EX080801CD) FDA

Teleflex Pilling Center-Action Forceps with Insulated Shafts (Cat no. 505015, 505039 and 505045) FDA

FDA

FDA

Oridion Capnostream20 Monitor with Nellcor Pulse Oximetry Module (Part no. CS08657) and Capnostream20 Monitor with Masiomor Pulse Oximetry Module (Part no. CS08659) FDA

MHRA 2007/010/024/261/001 2007/010/009/261/001

MHRA

MHRA

ConMed Frazier and Poole Suction Intruments (Cat no. 0031030, 0033080, 0033120, 0031100, 0031070, 0033180, 0031050, 0033110, 0035040, 0033100) MHRA

MHRA

Siemens Mevatron M2/PRIMUS Plus, Oncor Impresson Plus. Oncor Impression, ONCOR Avante Garde, Mevatron M2 Primus FDA

FDA

FDA

MHRA

CME Mckinley MicroSet NDEHP with 1.2 filter and SR segment (CME Code: 120-112SFV) (Lot no. 2856-7, 3173-7, 3226-7, 3343-7, 3344-7, 3345-7, 3346-7, 3347-7, 3397-7, 3398-7) MHRA

MHRA

MHRA

FDA

FDA

Stryker Triathlon MIS AP Sizer Body-left and Right, Triathlon MIS Femoral Adjustment Block and Triathlon MIS Modular Capture FDA

Stryker inTouch Critical Care bed (Model 2130) and Stryker inTouch Zoom Critical Care bed (Model 2140) FDA

FDA



























SA071251 Z-0146-208 to Z-0147-2008 Class II 2007/12/20

SA071252 Z-0459-2008 Class II 2007/12/20

SA071253 ConMed Accessory Electrode, Universal Electrodes and Ultra Clean Accessory Electrode Z-0452-2008 Class II 2007/12/20

SA071254 BD Visitec Nucleus Hydrodissector (Catalog # 585155, 585793) Z-0453-2008 to Z-0454-2008 Class II 2007/12/20

SA071255 Accuray Multiplan Treatment Planning Software Z-0364-2008 Class II 2007/12/20

SA071256 Cardinal Health Alaris Pump modules, model 8100 (Medley Pump modules) Z-0460-2008 Class I 2007/12/20

SA071257 Axya Bone Anchor Z-0331-2008 to Z- 0355-2008 Class II 2007/12/21

SA071258 Z-0241-2008 to Z-0242-2008 Class II 2007/12/21

SA071259 VNUS ClosureFAST catheters (Model no. CL7-7-100) Z-0132-2008 Class II 2007/12/21

SA071260 Z-0316-2008 to Z-0317-2008 Class II 2007/12/21

SA071261 Blackstone Medical Ascent POCTS (Posterior Occipital Cervical Thoracic System) Z-0363-2008 Class II 2007/12/21

SA071262 ACIST Multi-Use Syringe Kit (Model A2000; SKU# 014612, Catalog#800061-003) Z-0359-2008 Class II 2007/12/21

SA071263 VKS Tibial Trial, Right/Left, Prep Guide Z-0362-2008 Class II 2007/12/21

SA071264 Haemonetics cardioPAT System (Product list no 02050) Z-0358-2008 Class II 2007/12/21

SA071265 Single Use Surgical Tibbs cannula - S044 all batches 2007/011/028/601/002 FSCA 2007/12/21

SA071266 Liko Sabina II 350-slingbar (prod no. 2027002) 2007/011/021/291/001 FSCA 2007/12/21

SA071267 Baxter Infusor 2ml/hr with Tubing Flow Restrictor (Product Code: 2C1071KJP) 2007/012/010/061/003 FSCA 2007/12/21

SA071268 OPTI LION E-Plus Cassettes(Model: BP7507) 2007/011/026/061/019 FSCA 2007/12/21

SA071269 Cyberonics VNS Therapy Lead (Model 302) Cyberonics N/A Firm Initiated Field Action 2007/12/21

SA071270 Terumo Artifical vascular graft - Triplex N/A Firm Initiated Field Action 2007/12/21

SA071271 Bayer Contour TS blood glucose test strips Press Release N/A 2007/12/21

SA071272 Toshiba Aquilion 32 and Aquilion 64 39250 Type II 2007/12/31

SA071273 TD-Synergy Software (TD-SYN-01) 39374 Type II 2007/12/31

SA071274 Instrumentation Laboratory HemosIL RecombiPlasTin and Hemoliance RecombiPlasTin 39288 Type II 2007/12/31

SA071275 Beckman Coulter Cytomics FC 500 Flow Cytometer and Cytomics FC 500 MPL 39286 Type II 2007/12/31

SA071276 Beckman Coulter Cytomics FC 500 Flow Cytometer 37157 Type II 2007/12/31

SA071277 Beckman Coulter Sychron CX Systems salicylate reagent 39284 Type II 2007/12/31

Abbott ARCHITECT c8000 Processing Module (List no 106-01) and ARCHITECT c16000 Processing Module (List no 3L77-01) FDA

Roche Diagnostics LightCycler Capillaries (100uL) (Catalog # 03337090001, 04391039001, 03603946001, 03531414201) FDA

FDA

FDA

FDA

FDA

FDA

Mizuho OSI Allegro 6800 Imaging Table (Operating) and OSI ProFx Operating Room Table 6850 FDA

FDA

Zimmer Minimally Invasive Solutions Technology Offset Rasp Handles (REF/Catalog# 7712-35-01 and 7712-35-02) FDA

FDA

FDA

FDA

FDA

MHRA

MHRA

MHRA

MHRA

Terumo China (H.K.) Ltd.

FDA

Health Canada

Health Canada

Health Canada

Health Canada

Health Canada

Health Canada



















http://www.terumo.co.jp/English/press/index.html

http://www.fda.gov/oc/po/firmrecalls/bayer12_07.html








SA071278 Z-0137-2008 Class II 2007/12/31

SA071279 Z-0138-2008 to Z-0143-2008 Class II 2007/12/31

SA071280 Z-0145-2008 Class II 2007/12/31

SA071281 Z-0184-2008 to Z-0185-2008 Class II 2007/12/31

SA071282 Z-0286-2008 to Z-0287-2008 Class II 2007/12/31

SA071283 Z-0136-2008 Class II 2007/12/31

SA071284 Sultan Brand Mirror Defogger 39364 Type II 2007/12/31

SA071285 Hudson Action forceps with insulated shafts 38922 Type II 2007/12/31

SA071286 Span-America Medical Systems Pressureguard Easy Air Mattress 39236 Type II 2007/12/31

Freedom Designs TriPod w/Anti tipper Manual Wheelchair (Model no.: TriPod, Tripod LT and TriPod Pediatric LT with Trailing Anti-Tipper-Caster- Axle Link) FDA

Medtronic Prestige Cervical Disc System, Implant Trial (REF/Catalog#: 6972226, 6972246, 6972266, 6972247, 6972267, 6972287) FDA

Gen-Probe Accuprobe Group B Streptococcus Culture Identification Test (Catalog.: 2820B and Batch no.: 531379) FDA

Encore Reverse Shoulder Prothesis(RSP) System (Catalog #: 508-00-036 and 508-00-040) FDA

Ellex Solitarie Opthalmic Laser System (Model no : LP4532-DGS P/N303896; Solitaire-SGS P/N 3038960) and Ellex Integre Duo (Model no. LP1RG-S P/N 3040000) FDA

OrthoHelix Surgical Designs DRLock Bone Fixation Plates, Pegs and Screw Systems, Distal Screw and Distal Peg FDA

Health Canada

Health Canada

Health Canada











Local Agent



N/A N/A

N/A N/A


N/A N/A



N/A N/A

N/A N/A

Viasys Healthcare Hong Kong Ltd 2891 8730

N/A N/A

N/A N/A

N/A N/A






Smith & Nephew Ltd. 2648 7700

DePuy Inc (J&J)2738 2894


N/A N/A

N/A N/A







N/A N/A

N/A N/A

Starry Medical Technology Ltd 2381 0279

N/A N/A

N/A N/A

N/A N/A


N/A N/A

Medisource




N/A N/A

Fresenius Medical Care Asia Pacific Ltd.

N/A N/A

N/A N/A

N/A N/A





B. Braun Medical (Hong Kong) Ltd. 2277 6125




N/A N/A

BD 2575 8668


N/A N/A

N/A N/A

N/A N/A

N/A N/A


N/A N/A

N/A N/A

N/A N/A

Haemonetics (Hong Kong) Limited 2868 9218

N/A N/A

N/A N/A


N/A N/A

Cyberonics


Bayer Healthcare Ltd. (Hong Kong) 2814 7337


N/A N/A






N/A N/A


N/A N/A

N/A N/A

N/A N/A

N/A N/A

N/A N/A

N/A N/A

N/A N/A



SA071101 Smith & Nephew, Birmingham Hip Resurfacing Acetabular Cup Z-0017-2008 to Z-0033-2008 Class II 2007/11/01

SA071102 Remington Medical Disposable Urinary Leg Bags (Order no. 500-D and 1000-D) Z-0058-2008 Class II 2007/11/01

SA071103 Philips Heartstart XL Monitor/Defibrillator (Model : M4735A) Z-0062-2008 Class II 2007/11/01

SA071104 BD Microkeratome K3000 and K4000 (Cat No. 378660) Z-0062-2008 Class II 2007/11/01SA071105 Steris QFC1728 and QFC1729 Quick Connects Z-0101-2008 Class II 2007/11/01

SA071106 Stryker Trident PSL HA Cluster Acetabular Shell and HA solid back acetabular shell Z-0072-2008 to Z-0073-2008 Class II 2007/11/01

SA071107 Integra Flat Foot Implant KALIX II (Ref141 0xx) 2007/008/010/061/008 FSCA 2007/11/02

SA071108 Innovacon Strep A Rapid Test Strip and Strep A Rapid Test Device 2007/007/019/291/002 FSCA 2007/11/02

SA071109 Welch Allyn AED10 Automatic External Defibrillators N/A Class I 2007/11/05

SA071110 2007/010/026/601/002 FSCA 2007/11/07

SA071111 Boston Scientific RepliformR Tissue Regenration Matrix Boston Scientific(HK) Ltd N/A Firm Initiated Field Action 2007/11/07

SA071112 Z-0001-2008 Class II 2007/11/08

SA071113 Thoratec Implantable Ventricular Assist Devices (Catalogue No.: 10012-2555-001) N/A Firm Initiated Field Action 2007/11/08

SA071114 Roche High Pure System (Product Numbers 03502295001 and 03702995001) 2007/010/029/061/009 FSCA 2007/11/09

SA071115 GE Healthcare Flexi-DT Mobile Radiographic Table 2007/010/025/061/006 FSCA 2007/11/09

SA071116 Unomedical umbilical cord clamp clipper (Ref: 84006182) 2007/010/003/291/012 FSCA 2007/11/09

SA071117 Vernon-Carus Products containing 10x10 16ply X-Ray Detectable Swabs (49335) 2007/010/023/601/003 FSCA 2007/11/09

SA071118 Terumo Advanced Perfusion System 1 (Model no. 801046, Lot: 0049 AND 0079) 38444 Type II 2007/11/12

SA071119 Toshiba Aplio XG (SSA-790A) 38432 Type II 2007/11/12

SA071120 Baxter Healthcare Duoject EASY-Prep System 38628 Type II 2007/11/12

SA071121 Abbott Aeroset System-Creatine Kinase Assay (Model 7D63-30) 38476 Type II 2007/11/12

SA071122 Abbott Accelerator APS System Input/Output Module (IOM) (Model: 7L01-01) 38529 Type II 2007/11/12

SA071123 34805 Type II 2007/11/12

SA071124 Siemens Mevatron Linear Accelerators and Oncor Impression 38601 Type II 2007/11/12

Monthly Summary of Medical

*Note: FDA = Food and Drug Administration, United States of


FDA

FDA

FDA

FDA

FDA

FDA

MHRA

MHRA

FDA

Beckman Coulter FC500 Flow Cytometry Systems with CXP Acquisition Software and FC500 MPL Cytometry Systems with MXP Acquisition Software MHRA

Bio-logic System Corp - Telescoping Camera Pole Assembly (part no 585-CYBPSM and 580-VIDPOL) and assemblies (580IPCART and 580PNCART, model 580-VIDPOL) FDA

Thoratec Corporation

MHRA

MHRA

MHRA

MHRA

Health Canada

Health Canada

Health Canada

Health Canada

Health Canada

Siemens Mevatron Linear Accelerators, Oncor Expression Digital Linear Accelerator and Oncor Care Systems Health Canada

Health Canada












http://phx.corporate-ir.net/phoenix.zhtml?c=95989&p=irol-newsArticle&ID=1074762&highlight=





http://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/list/rec-ret_drugs-med_oct-dec_2007_e.html








SA071125 Beckman Coulter Immunoassay Analyzers 38546 Type II 2007/11/12

SA071126 Remel Wellcogen N Meningitidis B/E Coli K 37147 Type II 2007/11/12

SA071127 Respironics Various Devices and Accessories 38678 Type II 2007/11/12

SA071128 Z-0114-2008 Class II 2007/11/19

SA071129 Philips Brilliance CT Big Bore (Model No. 728243) Z-0121-2008 Class II 2007/11/19

SA071130 GE Voluson E8 ultrasound scanner (version 6.2.0 and 6.2.1) Z-0113-2008 Class II 2007/11/19

SA071131 Siemens Medical charge-particle radiation therapy system (Mevatron, Oncor and Primus) Z-0155-2008 to Z-0169-2008 Class II 2007/11/19

SA071132 GE Signa MFO/I Magnetic Resonance System Z-0170-2008 Class II 2007/11/19

SA071133 GE Sunisa Flexi-DT S0014115 Digital Table Flexi-DT Z-0075-2008 Class II 2007/11/19

SA071134 Abbott AxSYM Digoxin III Reagent Pack (List 6L07-20) Z-0064-2008 Class II 2007/11/19

SA071135 Z-0100-2008 Class II 2007/11/19

SA071136 Encore Medical Foundation Hip System Bipolar Modular Z-0082-2008 to Z-0099-2008 Class II 2007/11/19

SA071137 Cardinal Health Texium Closed Male Luer (CML) (Model No.: 10012241) Z-0218-2008 Class II 2007/11/19

SA071138 Varian Ximatron Digital Imaging (Ximavision) Z-0213-2008 Class II 2007/11/19

SA071139 Karl Storz Fluid Management Stand (Product No. 26601EQ-KT) Z-0144-2008 Class II 2007/11/19

SA071140 B Braun FT420T and FT430T CASPAR 2007/011/066/291/003 FSCA 2007/11/20

SA071141 APC Medical Bedside Temporary Cardiac Pacemaker (Model 4170) 2007/006/005/401/014 FSCA 2007/11/20

SA071142 P3 Medical Robertshaw Endobronchial tubes (Rubber, Disposable) 2007/010/030/601/002 FSCA 2007/11/20

SA071143 Respironics Esprit Ventilator 2007/077/077/291/004 FSCA 2007/11/20

SA071144 Olympus KeyMed BML-V232QR-26, BML-V232QR-30, BML-V242QR-30 and BML201Q 2007/009/025/601/002 FSCA 2007/11/22

SA071145 Pride Mobility Quantum 6000, 6000Z, 600, R-4000 and 1420, Pride LX Power wheelchair 2007/008/008/301/001 FSCA 2007/11/22

SA071146 DiaSorin LIAISON Toxo IgM (Cat no 310710, lot no: 035052, 035052/1, 035052/2) 2007/009/027/601/003 FSCA 2007/11/22

SA071147 Boston Scientific LeVeen SuperSlim Needle Electrodes Boston Scientific(HK) Ltd N/A Firm Initiated Field Action 2007/11/26

SA071148 Boston Scientific Impulse Angiographic Catheter Boston Scientific(HK) Ltd N/A Firm Initiated Field Action 2007/11/26

SA071149 2007/011/014/291/006 FSCA 2007/11/26

SA071150 Invacare Typhoon Power Wheelchairs 2007/004/020/261/001 FSCA 2007/11/26

SA071151 Bio-Rad Variant II Turbo Hemoglobin Testing System 2007/011/014/061/010 FSCA 2007/11/26

SA071152 Kavo Estertica E80 Treatment Unit 2007/011/013/061/011 FSCA 2007/11/26

SA071153 GE AW 4.2, AW Volumeshare and AW Volumeshare 2 38214 Type I 2007/11/27

Health Canada

Health Canada

Health Canada

Medtronic Sofamor Danek METRx System Bayonet Electrosurgical Pencil (REF (P/N) 9560575) FDA

FDA

FDA

FDA

FDA

FDA

FDA

Smiths Medical Portex Perfit Percutaneous Tracheostomy Tube Replacement Kit (Sterile Ref: 536090) FDA

FDA

FDA

FDA

FDA

MHRA

MHRA

MHRA

MHRA

MHRA

MHRA

MHRA

Ethicon Endopath 5mm Curved Dissector with Monopolar Cautery (Product Code: 5DCD, Lot no. D4HZ9Y) MHRA

MHRA

MHRA

MHRA

Health Canada





























SA071154 38700 Type II 2007/11/27

SA071155 GE Definium 8000 Table and Revolution XR/d Table 36689 Type II 2007/11/27SA071156 Abbott i-STAT Cartridges 38822 Type II 2007/11/27

SA071157 Philips Intellivue Patient Monitor System - Multi Measurement Server (Model no. M3001A) 32105 Type II 2007/11/27

SA071158 Medline Septoplasty Pack (Lot # 07CD1090 and 07DD3113) 38314 Type II 2007/11/27

SA071159 Zimmer Trilogy Cluster Hole Shell, Non Coated (Model 620006022, lot 26208600) 38744 Type II 2007/11/27

SA071160 Bard Atlas PTA Balloon Dilation Catheter (Model AT-120124, Lot GFRF1789) 38941 Type II 2007/11/27

SA071161 Patterson Dental Mirror Defogger / Solution (Lot 25622) 38884 Type I 2007/11/27

SA071162Hill-Rom Versacare Hospital Beds (model P3200 and P3201)

38502 Type II2007/11/27

Z-0240-2008 Class II

SA071163 GE OEC Insta Trak 3500 Plus with the Cranial Application Z-0183-2007 Class II 2007/11/27

SA071164 GE OEC Insta Trak 3500 Plus Fluoro Trak and Fluoro CAT Spinal Applications Z-0181-2007 Class II 2007/11/27

SA071165 Stryker wheeled stretcher (various models) Z-0219-2008 to Z-0239-2008 Class II 2007/11/27

SA071166 Stryker T2 Locking Screw (Cat no 1896-5070S) Z-0214-2008 Class II 2007/11/27

SA071167 Clarisonic Skin care system Z-0182-2008 Class II 2007/11/27

SA071168 Coloplast Elefant Suction- Irriagtion Device ASP1 2007/011/013/061/021 FSCA 2007/11/28

SA071169 Z-0288-2008 Class II 2007/11/29

SA071170 Z-0264-2008 Class II 2007/11/29

SA071171 Z-0255-2008 Class II 2007/11/29

SA071172 Z-0263-2008 Class II 2007/11/29

SA071173 Metrika A1CNOW+ Sampler 10-Test Kits (Product no.: 3022) Z-0289-2008 Class II 2007/11/29

SA071174 Boston Scientific PATHWAY Balloon Expandable Ureteral Access Sheath Boston Scientific(HK) Ltd N/A Firm Initiated Field Action 2007/11/30

SA071175 2007/008/009/061/014 FSCA 2007/11/30

SA071176 2007/011/029/291/001 FSCA 2007/11/30

BD BBL Fluid Thioglycollate Medium and BBL Trypticase Soy Broth (Model no 299108 and 299107) Health Canada


Health Canada

Health Canada

Health Canada

Health Canada

Health Canada

Health Canada

FDA

FDA

FDA

FDA

FDA

FDA

MHRA

Abbott Clinical Chemistry Aeroset/Architect (c Systems) Bilirubin Calibrator (List no 1E66-03 & 1E66-04) FDA

B. Braun Vena Tech LP Vena Cava Filter System (Item no/REF 05010024, Model no 40DLP) FDA

Biomet Interlok 67mm Fixed Cruciate Tibial Plate with Locking Bar; CO-CR-MO/TI 6AL 4V Alloy (Product ref 141232) FDA

Baxter Duploject Easy Prep, Fibrin Sealant Preparation and Application System ISO (Product codes: 1500949 - 1500952) FDA

FDA

CME Mckinley MicroSet NDEHP with 1.2 filter and SR segment (CME Code: 120-112SFV) (Lot no. 3399-7, 3400-7, 3401-7, 3402-7, 3403-7, 3404-7, 3405-7) MHRA

Smith & Nephew Femoral and Tibial Components of TC Plus, VKS and RT Plus Knee Implants MHRA

























Local Agent


N/A N/A


BD 2575 8668


N/A N/A

N/A N/A

Umedco 2765 8222


Boston Scientific (HK) Ltd 2960 7128

2620 8320

N/A N/A



N/A N/A

N/A N/A









Schmidt BioMed Tech (HK) Ltd



Wenline Company 2521 2439










N/A N/A

N/A N/A


Karl Storz Endoscopy China Ltd 2865 2411

B. Braun Medical (HK) Ltd 2277 6611

N/A N/A

N/A N/A



N/A N/A

N/A N/A




N/A N/A


N/A N/A



BD 2575 8668

GE Medical Systems Hong Kong Ltd. 2783 1838Abbott Laboratories Ltd. 2806 4021


N/A N/A


N/A N/A

N/A N/A

N/A N/A





N/A N/A

Coloplast (Hong Kong) Ltd N/A





N/A N/A


N/A N/A





SA071001 Boston Scientific(HK) Ltd N/A Firm Initiated Field Action 2007/10/02

SA071002 Cardinal Health Procedure Pack 2007/008/024/061/003 FSCA 2007/10/02

SA071003 CODAN PVB (Product Code STP 85, Lot No. 700265 & 700995) 2007/009/003/051/002 FSCA 2007/10/02

SA071004 Pride Mobility Power Chairs 2005/011/016/301/004 FSCA 2007/10/03

SA071005 Varian Acuity radiation therapy simulation systems CP-2007-001 Firm Initiated Field Action 2007/10/03

SA071006 Baxa Exacta-Mix 2400 OS v 1.07 (Model No. 8300-0073) Pharmacy Compounding System Z-1238-2007 Class I 2007/10/04

SA071007 GE Healthcare OEC9900, OEC9800 and OEC8800 2007/008/029/291/017 FSCA 2007/10/04

SA071008 Philips Gemini 16, Gemini GXL, Precedence and Brilliance Z-0013-2007 to Z-0014-2007 Class II 2007/10/04

SA071009 Z-0907-2007 to Z-0912-2007 Class II 2007/10/04

SA071010 Philips Pinnacle3 Radiation Therapy Planning (RTP) System and its associated Software Z-1212-2007 Class II 2007/10/04

SA071011 Intuitive brand Da Vinci Surgical System (Model No. IS2000, Part no. 351040-04) Z-1245-2007 Class II 2007/10/04

SA071012 Z-1244-2007 Class II 2007/10/04

SA071013 GE Innova 2100-IQ Digital Fluoroscopic Imaging System Z-1088-2007 Class II 2007/10/04

SA071014 Z-1243-2007 Class II 2007/10/04

SA071015 Z-1266-2007 to Z-1273-2007 Class II 2007/10/04

SA071016 Cardinal Health Pyxis Anesthesia System 3500 (Model 3500) Z-0555-2007 Class II 2007/10/04

SA071017 Stryker Trident PSL Acetabular Shell Z-1261-2007 Class II 2007/10/04

SA071018 Hitachi Medical Altaire Shoulder Coil Z-1263-2007 Class II 2007/10/04

SA071019 DeRoyal Assorted sterile surgical kits/trays Z-1205-2007 Class II 2007/10/04

SA071020 NxStage Cartridge Express (CAR-170) Z-1228-2007 Class II 2007/10/04

SA071021 Z-1216-2007 to Z-1218-2007 Class II 2007/10/04

SA071022 Merit Medical Surgical Convenience Kits, Custom and SPPT Z-1262-2007 Class II 2007/10/04

SA071023 BD Neisseria Meningitidis Antisera Group Y 37610 Type II 2007/10/04

SA071024 Siemens Biograph Duo LSO, Biograph 6 and Biograph 16 37227 Type II 2007/10/04

SA071025 Boots Blood Glucose Monitoring System (50-53-811) 2007/008/030/291/007 FSCA 2007/10/05

SA071026 GE Flexi-DT Mobile Radiographic Table 2006/008/017/601/229 FSCA 2007/10/05

SA071027 Otto Bock Standard Kimba Spring (Ref TS8423) 2007/004/010/301/001 FSCA 2007/10/08

SA071028 Boston Scientific Transend EX Standard 0.014" Guidewire Boston Scientific(HK) Ltd N/A Firm Initiated Field Action 2007/10/10


Boston Scientific Advanced Bionics Electrode Insertion Tool for HiRes 90KR with HiFocus HelixR Electrode

MHRA

MHRA

MHRA


FDA

MHRA

FDA

Philips Bucky, Digital and Easy Diagnost X-Ray System & Easy, Omni and Multi Diagnost Eleva FDA

FDA

FDA

Intuitive brand Da Vinci Surgical System Endoscopic Instrument Control System (Model IS1200, A4.3 SW Level) FDA

FDA

Cerner Millennium RadNet Auto Launch Study and Auto Launch Report Software functionalilites FDA

Davol Salute Fixation Reusable Handle, Fixation Reusable Shaft, Laparoscopic Sterile Implant Cartridge and Short Sterile Implant Cartridge FDA

FDA

FDA

FDA

FDA

FDA

Summit LX125 Swivel Collimator (Model D800), LX125V Swivel Collimator (Model E600) and PCS125 Swivel Collimator (Model F100) FDA

FDA

Health Canada

Health Canada

MHRA

MHRA

MHRA




























SA071030 CP-2007-093 Firm Initiated Field Action 2007/10/10

SA071031 GE Disposable Multi Absorber Canister Z-0006-2008 Class II 2007/10/11

SA071032 CVI OZ Palm Injector (Ref: OZ 1035) Z-0008-2008 Class II 2007/10/11

SA071033 Abbott PathFinder Bone Drill-Awl-Tap (Part no. 1156-50 & 1156-60) Z-0004-2008 to Z-0005-2008 Class II 2007/10/11

SA071034 Meretek BreathTek Urea Hydrolysis Rate Calculation CD, Version 1.3.5-January 1, '03 Z-0003-2008 Class II 2007/10/11

SA071035 Invacare REA Wheelchair Pelvic Belt 2007/006/025/261/001 FSCA 2007/10/11

SA071036 2007/009/028/291/005 FSCA 2007/10/11

SA071037 Varian Real-time Position Management System (RPM) version 1.7 2007/010/002/061/003 FSCA 2007/10/12SA071038 MAQUET ELS-Cannulae 2007/010/003/291/010 FSCA 2007/10/12

SA071039 2007/009/025/291/002 FSCA 2007/10/12

SA071040 Karl Storz Morcellator Cutter 12mm 2007/010/004/061/011 FSCA 2007/10/12

SA071041 Siemens Mobile Magnetom Harmony, Symphony and Sonata Systems 2007/008/029/291/010 FSCA 2007/10/12

SA071042 B Braun Aesculap e.motion and Columbus femoral components 2007/009/017/291/009 FSCA 2007/10/12

SA071043 2007/010/004/291/001 FSCA 2007/10/15

SA071044 Medtronic Sprint Fidelis Defibrillation Leads N/A Firm Initiated Field Action 2007/10/15

SA071045 Toshiba Nemio and Nemio XG Ultrasound systems 2007/009/026/061/007 FSCA 2007/10/16

SA071046 BD Multiset software version 2.1, 2.1.1 and 2.2 2007/009/027/061/011 FSCA 2007/10/16

SA071047 Otto Bock The Back 2, 3 and 4 2006/010/011/301/002 FSCA 2007/10/16

SA071048 Respironics DEAS Heated Wire Circuits 2007/009/011/291/007 FSCA 2007/10/16

SA071049 Masimo Rad 9 Pulse Oximeters 2007/008/014/061/002 FSCA 2007/10/16

SA071050 BD CellQuest Pro Software v4.0.2, 5.0.1, 5.1, 5.1.1, 5.2 and 5.2.1 2007/009/027/061/010 FSCA 2007/10/16

SA071051 Beckman Coulter Access Immunoassay Systems Ultrasensitive Insulin Reagent Kit 2007/009/027/601/002 FSCA 2007/10/16

SA071052 Park House Healthcare Phase Type 1 Cell (Product code: PHSP116) 2007/008/013/051/002 FSCA 2007/10/17

SA071053 Zeiss Hydromax (batches 6500 and 6271) 2007/009/010/291/009 FSCA 2007/10/17

SA071054 SensorCare Systems Control Unit 2006/008/007/401/006 FSCA 2007/10/17

SA071055 Cyberonics VNS Therapy Software, Model 250 Cyberonics N/A Firm Initiated Field Action 2007/10/17

SA071056 GE Healthcare Disposable Multi Absorber Canister with the EZ change Module 2007/008/001/601/004 FSCA 2007/10/18

SA071057 movingpeople.net Trophy 6 electrical scooters 2007/008/014/061/005 FSCA 2007/10/18

SA071058 Pluss GZL080A Wheelchair restraint belt 2004/012/008/401/008 FSCA 2007/10/18

SA071059 Boston Scientific IMAGERT II Angiographic Cather Boston Scientific(HK) Ltd N/A Firm Initiated Field Action 2007/10/18

SA071060 Siemens Digital Linear Accelerators 37632 Type II 2007/10/22

Boston Scientific Advanced Bionics PrecisionR Implantable Pulse Generator -UPNM365SC11100Varian RTP Exchange software (interface application that supports the electronic transfer of radiation treatment planning data)


FDA

FDA

FDA

FDA

MHRA

Dale 240 Blue Tracheostomy Tube Holders and Dale 242 Blue Tracheostomy Tube Holders for Neonates to Infants MHRA

MHRAMHRA

Stryker Locking Screw, Fully Threaded 5 x 70 mm (Cat. no. 1896-5070S, Lot/Batch no. K871252) MHRA

MHRA

MHRA

MHRA

Baxter Colleague Triple Channel Mono, CX and CXE Volumetric Infusion Pumps (Product Codes: 2M8153 & 2M9163) MHRA

Medtronic International, Ltd.

MHRA

MHRA

MHRA

MHRA

MHRA

MHRA

MHRA

MHRA

MHRA

MHRA

MHRA

MHRA

MHRA

Health Canada














http://wwwp.medtronic.com/Newsroom/NewsReleaseDetails.do?itemId=1192213397218&lang=en_US
















SA071061 Siemens C.Cam Imaging System 37749 Type II 2007/10/22

SA071062 Siemens Mevatron Linear Accelerators 37825 Type II 2007/10/22

SA071063 Siemens Troponin Ultra (TNI-ULTRA) Assay 37323 Type II 2007/10/22

SA071064 Baxter Amiscus Separator 37954 Type II 2007/10/22

SA071065 Medtronic TSRH Silo Spinal System- Sagittal Adjusting Screw for Rod - TI 37878 Type II 2007/10/22

SA071066 Radiometer Pump waste tube for blood gas analysis kit Z-0038-2008 Class II 2007/10/22

SA071067 Diagnostica STA Compact and STA Compact CT Z-0039-2008 Class II 2007/10/22

SA071068 Mallinckrodt Angiomat Illumena Injector with Auxiliary Console Z-0056-2008 Class II 2007/10/22

SA071069 I-Flow ON-Q PainBuster with OnDemand (Model PMB01) Z-0057-2008 Class II 2007/10/22

SA071070 Z-0014-2008 Class II 2007/10/22

SA071071 Z-0011-2008 Class II 2007/10/22

SA071072 Medtronic Model Model 7428 Kinetra and Model 7426 Soletra implantable neurostimulators Medtronic International, Ltd. N/A Firm Initiated Field Action 2007/10/22

SA071073 Abbott ARCHITECT cSystems 2007/009/014/601/003 FSCA 2007/10/23SA071074 Medtronic Nexframe Stereotactic System 2007/010/011/061/005 FSCA 2007/10/23SA071075 Gelita Medical Gelitacel Oxidized Cellulose Haemostat Gauze 2007/010/015/291/003 FSCA 2007/10/23

SA071076 BD Microtainer Safety Flow Lancets (Cat. No. 366356, 365759, 366357) Z-0044-2008 to Z-0046-2008 Class II 2007/10/25

SA071077 Days Healthcare Transportable Wheelchairs 2007/005/018/401/005 FSCA 2007/10/25SA071078 Siemens Clinitest hCG Cassette 2007/010/018/061/010 FSCA 2007/10/25SA071079 Smiths Medical EMS Ventilator circuits (Product code W196-002) MDA/2007/080 MDA 2007/10/25

Health Canada

Health Canada

Health Canada

Health Canada

Health Canada

FDA

FDA

FDA

FDA

Pml Microbiologicals Brain Heart Infusion Agar labeled BHIA + Vancomycin 6MCG/ML for screening for Vancomycin Resistant Enterococc (Cat# P1174) FDA

Pml Microbiologicals Brain Heart Infusion Agar labeled BHIA + Vancomycin 6MCG/ML Microbiological media plates (Cat# P1174) FDA

MHRA MHRA

MHRA

FDA

MHRAMHRA MHRA





















Local Agent


N/A N/A

N/A N/A

N/A N/A


Jaspo Limited 2713 0007





N/A N/A

N/A N/A


N/A N/A

N/A N/A

N/A N/A


N/A N/A

N/A N/A

N/A N/A

N/A N/A

N/A N/A

BD 2575 8668


N/A N/A









Suburfarm Investment and Trading Co. Ltd. 2780 9421


N/A N/A

N/A N/A

N/A N/A

Varian Medical Systems Pacific Inc. 2724 2836Maquet Hong Kong Limited 2393 9511


N/A N/A


N/A N/A




BD 2575 8668


N/A N/A

N/A N/A

BD 2575 8668


N/A N/A

N/A N/A

N/A N/A

N/A N/A


N/A N/A

N/A N/A









N/A N/A

N/A N/A

Tyco Healthcare (HKSAR) Limited 3157 7244

N/A N/A

N/A N/A

N/A N/A


Abbott Laboratories Ltd. 2806 4021Medtronic International, Ltd. 2919 1362

N/A N/A

BD 2575 8668

N/A N/ASiemens Ltd. 2810 7533





SA070901Boston Scientific Radial Jaw 4 Large Capacity Foreceps Boston Scientific(HK) Ltd N/A Firm Initiated Field Action 2007/09/03

SA070902Smith & Nephew Full radius, 4.5 mm Concave Disposable Blade (Item Code 7205335) 2007-008-024-061-012 FSCA 2007/09/05

SA070903 Jiangxi Sanxin / "Yixin" Disposable Intravenous Administration Set JianXi FDA N/A N/A 2007/09/06

SA070904Varian clinacs N/A Firm Initiated Field Action 2007/09/11

SA070905 BD Epicentre Microbiology Data Management 37021 Type II 2007/09/11

SA070906 BD FA Stretococcus Group A 36862 Type II 2007/09/11

SA070907Abbott Blood Glucose Meter: Precision Xtra, Optium, ReliOn Ultima, Rite Aid and Kroger N/A Press Release 2007/09/11

SA070908 Smiths Medical Hyperflex (Model 75 FHXL80) 30529 Type II 2007/09/14

SA070909 Smiths Medical Epidural Minipack and Epidural Syringe 29940 Type II 2007/09/14

SA070910 Terumo Advanced Perfusion System 1 Base and Roller Pumps 36601 Type II 2007/09/14

SA070911 Siemens Siregraph CF 36799 Type II 2007/09/14

SA070912 Randox Laboratories Carbon Dioxide Reagent 35983 Type II 2007/09/14

SA070913Gambro Prisma Continuous Fluid Management System 34788 Type II 2007/09/14

SA070914 Focus Surgery Sonablate 500 36419 Type II 2007/09/14

SA070915 Conmed Linvatec Ultrapower Burr and Ultrapower Burr Diamond 36844 Type II 2007/09/14

SA070916 PreMD PREVU* Point of Care Skin Sterol Test 36800 Type II 2007/09/14

SA070917Boston Scientific Mach 1 Guide Catheter Boston Scientific(HK) Ltd N/A Firm Initiated Field Action 2007/09/14

SA070918Boston Scientific Renegade HiFlo Microcatheter Kit Boston Scientific(HK) Ltd N/A Firm Initiated Field Action 2007/09/14

SA070919BD Vacutainer Safety-Lok Blood Collection Set with Preattached Holder (Catalog #368652) Z-0777-2007 Class II 2007/09/14

SA070920Molnlycke Biogel Skinsense Polyisoprene Surgical Gloves, Non-Latex, Sterile (Size 8) Z-1219-2007 Class II 2007/09/14

SA070921Abbott CELL-DYN 3000, CELL-DYN 3500 and CELL-DYN 3700 Hematology Analyzer Z-1198-2007 to Z-1200-2007 Class II 2007/09/14

SA070922Z-1201-2007 Class II 2007/09/14

SA070923 Abbott AxSYM System Digoxin III Reagent Pack Z-1202-2007 Class II 2007/09/14


MHRA


Health Canada

Health Canada

FDA

Health Canada

Health Canada

Health Canada

Health Canada

Health Canada

Health Canada

Health Canada

Health Canada

Health Canada

FDA

FDA

FDA

Sendx Medical (Radiometer Capenhagen ) ABL8O FLEX Software Version 1.10 (Model no. 914863) FDA

FDA


http://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/list/rec-ret_md-im_date_july-sept_2007_e.html


http://www.fda.gov/oc/po/firmrecalls/abbott08_07.html
















SA070924 Abbott Multi-Link Vision RX Coronary Stent System Z-1211-2007 Class II 2007/09/14

SA0709252007/008/022/601/001 FSCA 2007/09/17

SA070926 Biomet Austin-Moore and Thompson Endoprotheses 2007/008/028/061/007 FSCA 2007/09/17

SA070927 Roma Medical Bed Support Handle Model 5423 2007/007/005/401/001 FSCA 2007/09/17

SA070928 Elekta Synergy Linear accelerator XVI 2007/008/009/061/006 FSCA 2007/09/17

SA070929 Immucor Galileo 2007/008/016/401/005 FSCA 2007/09/17

SA070930 Chas A. Blatchford & Sons Ltd Derby Seat / Moulded Seat Insert 2006/009/019/301/001 FSCA 2007/09/17

SA070931 Philips MR Systems 2007/001/023/081/009 FSCA 2007/09/17

SA070932 Cascade Designs Varilite Back Support 2006/010/011/261/001 FSCA 2007/09/17

SA070933Abbott Precision Plus Blood Glucose Electrodes / Test Strips (Lot no. 96425) 2007/006/005/061/010 FSCA 2007/09/17

SA070934 Abbott Bilirubin Calibrator : 1E66-04 2007/008/014/601/004 FSCA 2007/09/17

SA070935 Depuy Engage Modular Revision Hip Implant Component 2007/007/025/061/016 FSCA 2007/09/17

SA070936 B. Bruan Medical Normal Saline Flush Syringes (Lot no "SFR") N/A Press Release 2007/09/18

SA070937 Stericom STE 4021 Proctoscope 2007/007/030/061/008 FSCA 2007/09/18

SA070938 Roche Online TDM Tobramycin for Modular Analytics {P} System 2007/004/017/131/017 FSCA 2007/09/18

SA070939Smith & Nephew CALAXO Interference Screw 2007/008/024/291/005 FSCA 2007/09/18

SA070940 BD Plastipak 1ml, 2ml, 5ml and 10ml hypodermic Luer slip syringes MDA/2007/071 MDA 2007/09/18

SA070941Universal Hospital Supplies Sterile suction connecting tubing (ref no. UN30026FFM) MDA/2007/070 MDA 2007/09/18

SA070942 Eschmann Electrosurgery bipolar unit (model TDB 60) MDA/2007/073 MDA 2007/09/18

SA070943 Welch Allyn AED20 Automatic External Defibrillators 37014 Class I 2007/09/19

SA070944 Abbott Muligent Acetaminophen Assay 37211 Type II 2007/09/19

SA070945Abbott Commander System Analyzer Class 4 37035 Type II 2007/09/19

SA070946 Abbott Architect System - Lipase Assay 35873 Type II 2007/09/19

SA07094731983 Type II 2007/09/19

SA070948 Medtronic Export XT Catheter 36691 Type II 2007/09/19

SA070949 Medtronic Paceart System Software - 2006 1st Edition 37173 Type II 2007/09/19

FDA

Dade Behring Dimension clinical chemistry system Total Bilirubin (TBIL) Flex reagent cartridge (Cat# DF67A) (Lot: FC8170) MHRA

MHRA

MHRA

MHRA

MHRA

MHRA

MHRA

MHRA

MHRA

MHRA

MHRA

FDA

MHRA

MHRA

MHRA

MHRA

MHRA

MHRA

FDA

Health Canada

Health Canada

Health Canada

Abbott Freestyle Freedom Blood Glucose Monitorinf System, Freestyle Blood Glucose Monitoring System, Freestyle Mini Blood Glucose Monitoring System Health Canada

Health Canada

Health Canada













http://www.fda.gov/oc/po/firmrecalls/braun09_07.html















SA070950 Siemens Biograph 2, Biograph 6 and Biograph 16 37033 Type II 2007/09/19

SA070951Smiths Medical Portex Perfit Percutaneous Dilational 28486 Type II 2007/09/19

SA070952 Smiths Medical Portex Epidural and Spinal Needle Set 30639 Type II 2007/09/19

SA070953Smiths Medical Graseby MS26 Syringe Driver 24935 Type II 2007/09/19

SA070954 Siemens Lithoskop 37262 Type II 2007/09/19

SA070955 Draeger Medical Babylog 8000 36919 Type II 2007/09/19

SA070956 Draeger Medical D-Vapor 37229 Type II 2007/09/19

SA07095735889 Type II 2007/09/19

SA070958 Remel Wellcogen Bacterial Antigen Test 37147 Type II 2007/09/19

SA070959 Ivoclar Vivadent Odyssey Diode Laser 37057 Type II 2007/09/19

SA070960 Invacare Action 2000 wheelchairs (blue frame) MDA/2007/074 MDA 2007/09/19

SA070961 Invacare Action 3 wheelchairs MDA/2007/075 MDA 2007/09/19

SA070962 Philips Isolation Transformer Z-1234-2007 Class II 2007/09/20

SA070963Boston Scientific Advanced Bionics Patient Controller SC-5400 (Joystick Controller) Boston Scientific(HK) Ltd N/A Firm Initiated Field Action 2007/09/21

SA070964 Bard Guidewire 70 cm x 1 mm (0.038") (Product Code: 5583705) 2007/009/010/291/012 FSCA 2007/09/21

SA070965 Vertec, Hologic Fluoroscan Premier and Encore Image Intensifiers 2007/008/003/601/006 FSCA 2007/09/21

SA070966 Cyberonics VNS Therapy Leads 2007/008/010/061/010 FSCA 2007/09/21

SA0709672007/007/030/051/009 FSCA 2007/09/21

SA070968Medtronic Spinal Implants: Colorado II Locking Nut#8634111 2007/009/010/291/015 FSCA 2007/09/21

SA0709692007/008/028/061/009 FSCA 2007/09/24

SA070970 Arjo Otter lift and Arjo Pool Lift 2007/006/014/601/002 FSCA 2007/09/24

SA070971 Smiths CADD Medication Cassette Reservoir 2007/007/024/061/008 FSCA 2007/09/24

SA070972 Stryker Radius Lcoking Caps (Cat. No. 486610000) Z-1239-2007 Class II 2007/09/27

SA070973 Stryker Wheeled Electric Stretcher Model 1550 Z-1009-2007 Class II 2007/09/27

SA070974Z-1221-2007 Class II 2007/09/27

SA070975Baxter Colleague CX Single Channel Volumetric Infusion Pumps, product code 2M8161 Z-1224-2007 Class I 2007/09/27

SA070976 Abbott ARCHITECT Prolactin MasterCheck Z-1222-2007 Class II 2007/09/27

Health Canada

Health Canada

Health Canada

Health Canada

Health Canada

Health Canada

Health Canada

Agfa Healthcare Impax DS3000 Diagnostic Pacs, Impax ES (5.0) for Cardiology, Impax for Cardiology, MA3000 Mammographic Workstation, Impax OT3000 Orthopaedic Workstation, Web 1000

Health Canada

Health Canada

Health Canada

MHRA

MHRA

FDA

MHRA

MHRA

MHRA

Roche LightCycler 2.0 Instrument Software v 4.05.415 Deficiency and LightCycler SeptiFast Test M MHRA

MHRA

Metrax Primedic - DefiMonitor Models DX1, XD3, XD10, XD30, XD100, XD300, XD110, XD330 MHRA

MHRA

MHRA

FDA

FDA

Biomet 3i LTX XP Miniplant, Dental Implant, Sterile (Model No LTX3211 and Model LTX3213) FDA

FDA

FDA




























SA070977 BD ReliOn 0.5cc 3g x 8mm Bilster Pak U-100 Syringe Z-1226-2007 Class II 2007/09/27

SA070978Kimberly Clark BALLARD BAL CATH Kit Kimberly Clark Health Care N/A Firm Initiated Field Action 2007/09/27

SA070979 Medtronic Intersept 3608 Sterile tubing (Lot 7626621) Z-1227-2007 Class II 2007/09/27

SA070980 Nicolet Biomedical BMSI " MicroJack" PN672-510000 Z-1225-2007 Class II 2007/09/27

SA070981 Newport HT50 Ventilator (all Models) Z-1192-2007 Class II 2007/09/27

SA070982 Sorin SR Single Chamber Pacemakers 2007/009/012/291/004 FSCA 2007/09/27

SA070983 G & S Smirthwaite SAMBA Supportive Seating System 2006/010/012/301/001 FSCA 2007/09/27

SA070984 Roma Medical Aids Bed Grab Handle (Model 5425) 2007/007/030/051/005 FSCA 2007/09/28

SA070985 Pegasus Euro Adaptor (Part No. MSM14337) 2007/003/008/081/010 FSCA 2007/09/28

SA070986 Varian Clinacs with Type 3 accessories 2007/009/012/061/006 FSCA 2007/09/28

SA070987 R82 Vests and Belts 2006/010/012/301/004 FSCA 2007/09/28

SA070988 Gambro Spectra Optia System 2007/009/019/061/002 FSCA 2007/09/28

SA070989B BRAUN Excia Hip Endoprosthesis, cementless, NC410T (LOT 51283009) 2007/009/017/291/010 FSCA 2007/09/28

FDA

FDA

FDA

FDA

MHRA

MHRA

MHRA

MHRA

MHRA

MHRA

MHRA

MHRA















Local Agent



Jindun International (HK) Ltd 2851 0879


BD 2575 8668

BD 2575 8668






N/A N/A

Gambro China Ltd. 2839 7010

N/A N/A

N/A N/A

N/A N/A



BD 2575 8668

N/A N/A


N/A N/A





N/A N/A

N/A N/A

N/A N/A

N/A N/A

Uninet Technology Ltd 2838 8423

N/A N/A


N/A N/A





N/A N/A


Smiths & Nephew Healthcare (Hong Kong) 2648 7700

BD 2575 8668

N/A N/A

N/A N/A

N/A N/A















Agfa Hong Kong Limited 2555 9421

N/A N/A

N/A N/A

N/A N/A

N/A N/A



N/A N/A

N/A N/A

GM Medical (Hong Kong) Ltd 2783 1838



N/A N/A

Arjo Far East Ltd (Hong Kong) 2508 9553




N/A N/A

N/A N/A



BD 2575 8668

N/A N/A


N/A N/A

N/A N/A

N/A N/A

N/A N/A

N/A N/A

N/A N/A


N/A N/A


N/A N/A




SA070801 BCI Autocorr Plus patient monitor Goodwin Healthcare Ltd. N/A Firm Initiated Field Action 2007/08/02

SA070802Cousin Biotech Intrmesh TI - FBIOT12020, FBIOT12025, FBIOT13030, FBIOT13050 2007/006/012/291/002 FSCA 2007/08/06

SA070803Philips X-Ray System BV Pulsera and Endura rel.2 with Remote Control 2007/007/023/061/018 FSCA 2007/08/06

SA070804 GE Healthcare OEC InstaTrak 3500 Plus System 2007/007/025/061/013 FSCA 2007/08/06

SA0708052007/007/019/601/002 FSCA 2007/08/06

SA070806GE Healthcare Extended Range Transmitter (Catalog Part 1004070 , 1003991) FSCA 2007/08/06

SA070807 Tyco Kendall Curity Suprapubic Catheter Sets 2007/007/012/051/003 FSCA 2007/08/06

SA070808 Fresenius Medical Care HD Catheters 2007/007/019/291/018 FSCA 2007/08/06

SA070809 Teleflex Medical Hudson RCI Large Volume Nebuliser 2007/006/012/401/015 FSCA 2007/08/06

SA070810 Abbott ACCELERATOR APS System (7L01-01) 2007/005/023/601/001 FSCA 2007/08/06

SA070811 Trinity Biotech Captia Measles IgM ELISA Test Kit 2007/007/009/061/003 FSCA 2007/08/06

SA070812 Medtronic Intersept Filtered Cardiotomy Reservior (Model 1351) Z-1110-2007 Class II 2007/08/06

SA070813 Abbott Architect AUSAB Assay Z-1096-2007 to Z-1098-2007 Class II 2007/08/06

SA070814Sunnex Celestial Star MR-16 and Tri-Star Surgical Exam Light MR-16 (Lamp Holder) Z-1100-2007 to Z-1101-2007 Class II 2007/08/06

SA070815 Allez Medical Applications 4Closure Surgical Fascia Closure System Z-1080-2007 to Z-1085-2007 Class II 2007/08/06

SA070816 Gebauer Pain Ease Mist Spray Z-1057-2007 to Z-1062-2007 Class II 2007/08/06

SA070817 Gambro Prismaflex Hemodialysis Unit 2007/007/018/061/005 FSCA 2007/08/06

SA070818 Performance Health Products AXXIS, Comfort and V-Trak 2006/010/011/301/001 FSCA 2007/08/07

SA070819 Philips Brilliance 40/64 CT Scanners 2007/007/024/291/007 FSCA 2007/08/07

SA070820 Pelican Proctoscope (Product Code 400340) 2007/007/030/061/008 FSCA 2007/08/07

SA070821 Medtronic SynchroMed EL Pump 2007/007/025/291/008 FSCA 2007/08/07

SA070822Beckman Coulter Cytomics FC 500 Flow Cytometer with CXP Software 2007/008/002/061/011 FSCA 2007/08/08

SA070823 Cardinal Health Alaris IV Administration Infusion Sets Z-1020-2007 Class II 2007/08/09

SA070824Cardinal Health Alaris IV Administration Infusion Sets, Low Sorbing Extension Set Z-1078-2007 Class II 2007/08/09


MHRA

MHRA

MHRA

GE Healthcare CardioLab/Mac-Lab IT/ComboLab IT Electrophysiology and Haemodynamic Systems MHRA

MHRA 2007/007/027/291/008, 2007/007/027/291/007

MHRA

MHRA

MHRA

MHRA

MHRA

FDA

FDA

FDA

FDA

FDA

MHRA

MHRA

MHRA

MHRA

MHRA

MHRA

FDA

FDA





http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2031925&ssTargetNodeId=967%20/%20http://www.mhra.gov.uk/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2031927&ssTargetNodeId=967




















SA070825 Zimmer M/DN Intramedullary Fixation System 32026 Type II 2007/08/09

SA070826 Cook Fixed Core Stainless Stell Wireguide 35942 Type II 2007/08/09

SA070827 Cook Black Silicone Filiform Double Pigtail Stent Set 36639 Type II 2007/08/09

SA07082836465 Type II 2007/08/09

SA070829 Siemens ECAT 36463 Type II 2007/08/09

SA070830 Siemens Sonoline Antares and Acusion Antares Premium Edition 36560 Type II 2007/08/09

SA070831 Siemens Biograph 6 and Biograph 16 36426 Type II 2007/08/09

SA070832 Stryker Peek Electrosurgical Handle 34278 Type II 2007/08/09

SA070833 Radiometer D711 Reference Membrane ABL7XX 36506 Type II 2007/08/09

SA070834 Getinge Castle Steam Sterilizers 35738 Type II 2007/08/09

SA070835 Sensor Health Products Cary Blair Enteric Pathogen Transport 36355 Type II 2007/08/09

SA070836 Cybernius Nephroncare Software 5.1 Full and 5.1A5 34861 Type II 2007/08/09

SA070837 Focus Diagnostics HerpeSelect 1 and 2 Immunoblot IgG Kit 36279 Type II 2007/08/09

SA070838 BHM Medical Nautica Patient Lift 34044 Type I 2007/08/09

SA070839 Georg Kramer GES.M.B.H. & Co. KG - Atlantis Patient Lift Model 9500 36188 Type I 2007/08/13

SA070840Specialised Orthotic Services Stroller buggies 2007/005/009/061/011 FSCA 2007/08/14

SA070841Draeger Medical Anaesthesia Machine with additional monitor (device combination) 2007/008/007/051/007 FSCA 2007/08/15

SA070842 Cardinal Health Propofol-Schnider Upgrade Kit 2007/007/027/291/009 FSCA 2007/08/15

SA070843Draeger Medical Falcon single-use paediatric Miller blades size 00, 0 & 1 MDA/2007/062 MDA 2007/08/15

SA070844 Philips X-Ray System Allura Xper FD20/10 Rel. 1.2., FD20 Rel.2.2. 2007/008/010/061/012 FSCA 2007/08/16

SA070845Finsbury Orthopaedics ADEPT Acetabular Cups 2007/008/001/291/016 FSCA 2007/08/16

SA070846NMPE ISOLOC Software Versions 4.2, 6.0 and 6.5 Class II 2007/08/17

SA070847Biomet Straight Magnum Inserter Handle Z-1151-2007 Class II 2007/08/17

SA070848ACT VS-1000 Senator Prosthetic Foot Z-1149-2007 Class II 2007/08/17

SA070849 Accellent Precision Bipolar Device ClearGlide EVH Small Z-1156-2007 to Z-1158-2007 Class II 2007/08/17

SA070850Abbott Embrace Enteral Pump Z-1141-2007 Class II 2007/08/17

Health Canada

Health Canada

Health Canada

Boston Scientific Amplatz, CLS Cure, Internal Mamnary, Kimmy, Multipurposse and Voda Guide Catheters Health Canada

Health Canada

Health Canada

Health Canada

Health Canada

Health Canada

Health Canada

Health Canada

Health Canada

Health Canada

Health Canada

Health Canada

MHRA

MHRA

MHRA

MHRA

MHRA

MHRA

FDA Z-1145-2007 to Z-1147-2007 and Z-1152-2007 to Z-1155-2007

FDA

FDA

FDA

FDA




























SA070851 Possis AngioJet XVG Thrombectomy Sets Z-1131-2007 Class II 2007/08/17

SA070852COOK PTFE Wire Guide with 3 cm flexible tip Z-1162-2007 Class II 2007/08/17

SA070853 Philips Medical System Information Centre 2007/008/013/061/003 FSCA 2007/08/20

SA070854ThermoFisher Scientific Infinity Ammonia Liquid Stable Reagent 2007/004/003/291/010 FSCA 2007/08/20

SA070855MAQUET Vessel Cannulae Product Code GK03 and S 1184 2007/008/010/061/004 FSCA 2007/08/20

SA070856Boston Scientific Precision Spare Suture Sleeve Boston Scientific(HK) Ltd N/A Firm Initiated Field Action 2007/08/22

SA070857Abbott CELL-DYN 1700 Hematology Analyzer Z-1170-2007 to Z-1171-2007 Class II 2007/08/23

SA070858 Lifescan One Touch SureSoft Lancing Device Z-1165-2007 Class II 2007/08/23

SA070859 Sendx Medical ABL77 Cal Pack, Model No. 944-069 Z-1173-2007 Class II 2007/08/23

SA070860GE Medical System Mac-Lab System, CardioLab System, ComboLab System Z-1132-2007 to Z-1134-2007 Class II 2007/08/23

SA070861 Sisus- Bath Helper / Sisus All In One Z-1172-2007 Class II 2007/08/23

SA070862Z-1175-2007 to Z-1177-2007 Class II 2007/08/23

SA070863 Hill-Rom TotalCare Duo 2 MDA/2007/065 MDA 2007/08/23

SA070864 Femcare Nikomed Unimax Disposable Shielded Trocar and Cannula 2007/008/020/051/005 FSCA 2007/08/23

SA070865 North Eos single-use Cusco screw type vaginal specula MDA/2007/066 MDA 2007/08/23

SA070866 Depuy SmartSeal Pressurisers 2007/007/016/061/005 FSCA 2007/08/27

SA070867 Biomet Optigun 4195 2007/008/014/061/008 FSCA 2007/08/27

SA070868Gambro AK-95 36667 Type I 2007/08/28

SA070869Terumo Advanced Perfusion System - Roller Pump and Centrifugual Control Unit 33984 Type II 2007/08/28

SA070870 Terumo Advanced Perfusion System - Modules 33985 Type II 2007/08/28

SA070871 Terumo Advanced Perfusion System 1 and Central Control Monitor 33982 Type II 2007/08/28

SA070872 Terumo Advanced Perfusion System 1 (Model 801041) 33981 Type II 2007/08/28

SA070873 Terumo Advanced Perfusion System 1 (Model 801040, 801041) 36673 Type II 2007/08/28

SA070874Terumo Sarns Modular Perfusion System 9000, 8000 and Centrifugal System 36696 Type II 2007/08/28

SA070875 Biomerieux AacT/Alert 3D, BacT/Alert 3D 240, BacT/Alert 3D Combi 36531 Type II 2007/08/28

SA070876 Kodak Direct View DR3000 System 80kW Generator 36629 Type II 2007/08/28

SA070877 BD Procount Progenitor Cell 33951 Type II 2007/08/28SA070878 BD Difco Shigella Antiserum Poly A1 28852 Type II 2007/08/28

FDA

FDA

MHRA

MHRA

MHRA

FDA

FDA

FDA

FDA

FDA

Louisville ApI Diagnostics APhL HRP IgG & IgM ELISA Kit, APhL HRP IgG ELISA Kit and APhL HRP IgM ELISA Kit FDA

MHRA

MHRA

MHRA

MHRA

MHRA

Health Canada

Health Canada

Health Canada

Health Canada

Health Canada

Health Canada

Health Canada

Health Canada

Health Canada

Health Canada

Health Canada





























SA070879Steris Amsco Century Medium Steam Sterilizer & SFPP Steam Sterilizer Z-1193-2007 Class II 2007/08/30

SA070880 Dade Behring EasyLink Informatics System Software version 3.0 Z-1174-2007 Class II 2007/08/30

SA070881 Carmel PhaSeal Protector 14, 21 and 50 (Item No. P14, P21 and P50) Z-1178-2007 to Z-1181-2007 Class II 2007/08/30

FDA

FDA

FDA






Local Agent

Goodwin Healthcare Ltd. 2408 8838

N/A N/A







N/A N/A


N/A N/A



N/A N/A

N/A N/A

N/A N/A


N/A N/A


N/A N/A


Beckman Coulter Hong Kong Ltd. N/A

Vita Company Limited N/A

Vita Company Limited N/A




Cook Asia Ltd

Cook Asia Ltd






N/A N/A

N/A N/A

N/A N/A

N/A N/A

N/A N/A

N/A N/A

N/A N/A

N/A N/A


N/A N/A



N/A N/A

N/A N/A

N/A N/A

N/A N/A

N/A N/A


(1) 2781 0232; (2) 2541 1041

(1) 2781 0232; (2) 2541 1041


N/A N/A

Cook Asia Ltd


N/A N/A

Maquet Hong Kong Limited 2393 9511





N/A N/A

N/A N/A

N/A N/A

N/A N/A

N/A N/A


N/A N/A









Care Stream Health 2564 9751

BD 2575 8668

BD 2575 8668

(1) 2781 0232; (2) 2541 1041



N/A N/A

N/A N/A




SA070701 Abbott m2000sp Instrument and m1000 Instrument 2007/006/020/601/002 FSCA 2007/07/03

SA070702 Boston Scientific Polaris DXTM Sterrable Diagnostic Catheters Boston Scientific(HK) Ltd N/A Firm Initiated Field Action 2007/07/03

SA070703 Roche Cortisol Reagent Z-0977-2007 Class II 2007/07/05

SA070704 GE Healthcare Diamond Mannographic X-Ray System Z-0976-2007 Class II 2007/07/05

SA070705 Varian Medical LINAC Scapel Treatment Planning System Z-0978-2007 Class II 2007/07/05

SA070706 Toshiba Aplio 80 and Aplio 50 Digital Ultrasound System Z-0985-2007 to Z-0986-2007 Class II 2007/07/05

SA070707 Oasis Disposable Bimanuals Irrigation and Aspiration Set Z-0740-2007 to Z-0742-2007 Class II 2007/07/05

SA070708 Philips Masimo SPO2 modules 2007/002/020/401/006 FSCA 2007/07/05

SA070709 Abbott ClearStar enteral feeding pump 2007/006/025/061/002 FSCA 2007/07/05

SA070710 Baxter CS3000 Apheresis Kits 2007/006/029/291/010 FSCA 2007/07/06

SA070711 Baxter Sample First Sampling System 2007/007/002/291/004 FSCA 2007/07/06

SA070712 Varian Clinacs with Type 3 accessories 2007/006/029/291/003 FSCA 2007/07/06

SA070713 Integra Neurosciences Elektrotm ET630 and ET621 2007/007/003/291/024 FSCA 2007/07/06


SA070715 Ortho-Clinical Diagnostics Vitros Chemistry Products 5, 1 FS Chemistry System - Software 35306 Type II 2007/07/10

SA070716 Ortho-Clinical Diagnostics Reagent Red Blood Cells Ficin Panel System resolve Panel C 35880 Type II 2007/07/10

SA070717 Teleflex Medical Non Absorbable Stainless Steel Suture 35784 Type II 2007/07/10

SA070718 Siemens Medical Simview 3000 and Simview NT 34690 Type II 2007/07/10

SA070719 Siemens Medical Linear Accelerators 34805 Type II 2007/07/10

SA070720 Bayer Healthcare Ascencia Contour Blood Glucose Meter 35772 Type II 2007/07/10

SA070721 Abbott Axsym System - Quinidine Assay and X Systems Quinidine Assay 35874 Type II 2007/07/10

SA070722 Abbott Architect System - Analyzer - Class 2 35299 Type II 2007/07/10

SA070723 Elekta Precise Plan 35590 Type II 2007/07/10

SA070724 Gyrus CyberWand Ultrasonic Lithotriptor 35779 Type II 2007/07/10


MHRA

FDA

FDA

FDA

FDA

FDA

MHRA

MHRA

MHRA

MHRA

MHRA

MHRA

Boston Scientific VASOVIEWR UniportR Plus EVH System w/ Bisector VasoView 7xB Bisector

Health Canada

Health Canada

Health Canada

Health Canada

Health Canada

Health Canada

Health Canada

Health Canada

Health Canada

Health Canada
























SA070725 Chiltern Wispa Attachment Handle 34860 Type I 2007/07/10

SA070726 Airox Legendair Ventilator 35588 Type I 2007/07/10

SA070727 AMO VISX WaveScan WaveFront Systems 2007/006/028/061/010 FSCA 2007/07/10

SA070728 Pride Mobility Power Chairs Jazzy 610, 1107, 1650 and Quantum 610, 1107 2006/008/017/301/002 FSCA 2007/07/10

SA070729 AIDAPT Coniston Swivel Bathers 2007/003/002/401/004 FSCA 2007/07/11

SA070730 AIDAPT Solo Bed Rail 2007/004/024/291/010 FSCA 2007/07/11

SA070731 Class II 2007/07/12

SA070732 Smiths Medical Pneupac VR1 Standard and VR1 Responder Z-0991-2007 Class II 2007/07/12

SA070733 Z-1002-2007 to Z-1005-2007 Class II 2007/07/12

SA070734 Terumo Advanced Perfusion System 1 Model 801763 and 801764 Z-0929-2007 to Z-0930-2007 Class II 2007/07/12

SA070735 Invacare Storm TDX Power Wheelchair Z-0966-2007 Class II 2007/07/12

SA070736 Diagnostica Stago STA Liatest VWF: Ag Z-0853-2007 Class II 2007/07/12

SA070737 Philips Medical HDIIXE Diagnostic Ultrasound System Z-0987-2007 Class II 2007/07/12

SA070738 Kodak Direct View DR7500 System Z-0738-2007 Class II 2007/07/12

SA070739 Radiometer Medical SafeClinitubes Z-0975-2007 Class II 2007/07/12

SA070740 Instersurgical Solus Flexible Wire-Reinforced Airway 2007/007/009/061/005 FSCA 2007/07/13

SA070741 Boston Scientific 6 French Guider Catheter Boston Scientific(HK) Ltd Firm Initiated Field Action 2007/07/13

SA070742 Arizant Ranger Standard Flow Blood/Fluid Warming Disposable Sets 2007/006/029/601/004 FSCA 2007/07/17

SA070743 Siemens CENTRA Active BTE Hearing Instrument 2007/004/018/601/810 FSCA 2007/07/17

SA070744 BD Trypticase Soy Agar dehydrated culture media BD Firm Initiated Field Action 2007/07/17

SA070745 Molnlycke Procedure Tray - Extraction of Wisdom Teeth 2007/007/005/051/003 FSCA 2007/07/18

SA070746 Boston Scientific Mach 1 Guide Catheter Boston Scientific(HK) Ltd Firm Initiated Field Action 2007/07/18

SA070747 Terumo TenderFlow Pediatric Arterial Cannulae Z-0874-2007 to Z-0885-2007 Class II 2007/07/19

SA070748 Abbott Patrol Enteral Pump Set Z-0888-2007 Class II 2007/07/19

SA070749 Abbott AxSYM Troponin-I ADV Reagent Pack Z-1023-2007 to Z-1040-2007 Class II 2007/07/19

SA070750 Ossur Total Knee Model Number 2100 Z-1076-2007 Class II 2007/07/19

Health Canada

Health Canada

MHRA

MHRA

MHRA

MHRA

GE OEC 9900 Elite, OEC 9800, OEC 8800, OEC 6800, OEC 2800 mobile AND oec Miniview 6800 mobile Fluoroscopic x-ray system FDA Z-0848-2007 to Z-0852-2007, Z-0928-

2007

FDA

Terumo Perfusion System 8000 Roller Pump, Model 8000 and Perfusion System 9000 Roller Pump Model 9000 FDA

FDA

FDA

FDA

FDA

FDA

FDA

MHRA

MHRA

MHRA

MHRA

FDA

FDA

FDA

FDA




















http://www.fda.gov/bbs/topics/enforce/2007/ENF01013.html





SA070751 Z-0989-2007 to Z-0990-2007 Class II 2007/07/19

SA070752 GE Healthcare Innova 2100 IQ and Innova 3100/3100IQ Fluoroscopic Imaging System Z-1043-2007 to Z-1044-2007 Class II 2007/07/19

SA070753 Cardinal Health AirLife nCPAP System Driver Z-1075-2007 Class II 2007/07/19

SA070754 Anspach Single Use, Sterile Bone Cutting Burrs Z-1008-2007 Class II 2007/07/19

SA070755 Boston Scientific AccuStick II with 0.38" Stainless Steel J Tip and .18" Nitinol Guidewire Boston Scientific(HK) Ltd N/A Firm Initiated Field Action 2007/07/20

SA070756 Baxter Colleague Triple Channel Volumetric Infusion Pumps N/A Press Release 2007/07/23

SA070757 Teleflex Infant Nasal CPAP Cannulae/Systems 2007/07/24

SA070758 Roche Elecsys Digoxin (Product No. 1182079322) 35510 Type II 2007/07/25

SA070759 Roche PSM QC and Validation Modules 35915 Type II 2007/07/25

SA070760 Philips Heartstart XL Monitor/Defibrillator 36081 Type II 2007/07/25

SA070761 36232 Type II 2007/07/25

SA070762 Cryolife Bioglue Rigid Applicator Tips 35406 Type II 2007/07/25

SA070763 Agfa Heartlab Cardiovascular 36244 Type II 2007/07/25

SA070764 Instrumentation Laboratory ACL TOP Coagulation Analyzer 36144 Type II 2007/07/25

SA070765 Varian RadioCamera System 35986 Type II 2007/07/25

SA070766 Roche Amplilink 35912 Type II 2007/07/25

SA070767 Elekta Precise Destop Release 4.2/5.0 35828 Type II 2007/07/25

SA070768 Teleflex Medical Capio PGA Suture and Polyester Non-Absorbable Suture 36080 Type II 2007/07/25

SA070769 35473 Type II 2007/07/25

SA070770 Maquet KION/KION-I Anasthesia Workstation 2007/011/021/401/007 FSCA 2007/07/25

SA070771 Universal Hospital Supplies Ltd Sterile Suction Connecting Tubing 2007/007/016/291/007 FSCA 2007/07/25

SA070772 nSpire Gas Delivery hoses 2007/006/004/601/001 FSCA 2007/07/27

SA070773 Stapeline circular stapler and hemorrhoidal stapler 2007/007/006/061/008 FSCA 2007/07/27

SA070774 HemoCue Glucose 201 RT System 2007/007/019/291/007 FSCA 2007/07/27

GE Healthcare OEC 9900 ESP-15 Elite and OEC 9800 ESP-15 C-Arm Fluoroscopic X-Ray System FDA

FDA

FDA

FDA

FDA

Health Canada

Health Canada

Health Canada

AGFA OT3000 Orthopaedic Workstation, MA3000 Mammographic Workstation, Impax DS3000 Health Canada

Health Canada

Health Canada

Health Canada

Health Canada

Health Canada

Health Canada

Health Canada

Walter Lorenz Dual Rail Distractor, Flex QC Shaft Extension, Pediatric Distractor, QC Patient Driver, QC Removal Tool, QC Shaft Extension, QC Solid Shaft Removal Tool Health Canada

MHRA

MHRA

MHRA

MHRA

MHRA
























SA070775 2007/002/001/401/009 FSCA 2007/07/27

SA070776 Baxter COLLEAGUE, COLLEAGUE CX, and FLO-GARD volumetric infusion pumps Class I 2007/07/27

Medtronic N'Vision InterStim-B Software, N'Vision Clinician Programmer, InterStim iCon Patient Programmer, InterStim Implantatble Neurostimuator, InterStim II Implantable Neurostimulator

MHRA

FDA





Local Agent







N/A N/A






N/A N/A




N/A N/A






N/A N/A

N/A N/A



N/A N/A

Forever Health Medical Instrument Ltd 2770 9922


N/A N/A

N/A N/A

N/A N/A


Smiths Medical (S.E. Asia) Ltd.



N/A N/A

N/A N/A


Kodak (Hong Kong) Ltd

N/A N/A

N/A N/A


N/A N/A


BD 2575 8668

N/A N/A





N/A N/A




N/A N/A

N/A N/A



N/A N/A





N/A N/A


N/A N/A



N/A N/A

N/A N/A

N/A N/A


N/A N/A

N/A N/A

N/A N/A

Science International Corp 2543 7442


Monthly Summary of Medical Device Safety Alerts - June 2007*Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada


SA070601 Invacare Flamingo mobile patient hoists MDA/2007/043 MDA 2007/06/01

SA070602 Baxter HomeChoice and HomeChoice PRO Automated Peritoneal Dialysis System 2007/005/024/061/012 FSCA2007/06/04

SA070603 Olympus CRP Latex OSR6x99 and Ferritin OSR6x50/OSR6x138 Reagents 2007/002/019/401/010 FSCA2007/06/04

SA070604 BD BBL Trypticase Soy Agar w/5% Sheep Blood (TSA II) // MacConkey II Agar I Plate BD N/A Firm Initiated Field Action2007/06/04

SA070605 Kimberly Clark Health Care Microcuff Pediatric Oral/Nasal Magill endotracheal tube Kimberly Clark Health Care N/A Firm Initiated Field Action2007/06/04

SA070606 Roche COBAS Taqman HCV and HIV-1 Test 2007/005/031/061/014 FSCA2007/06/05

SA070607 2007/004/011/051/001 FSCA2007/06/05

SA070608 MAQUET Mobile O.R. table 1131.12XO, BETASTAR 2007/005/031/051/010 FSCA2007/06/06

SA070609 Z-0833-2007 to Z-0835-2007 Class II2007/06/07

SA070610 Medtronic Strata NSC Lumboperitoneal Shunt Kit 2007/006/004/051/016 FSCA2007/06/08

SA070611 Clearview HCG Test Kits (Product Code 500158, Kit Lot no. HG0050) 2007/006/006/061/002 FSCA2007/06/11

SA070612 Siemens AG Sienet Magicstore 35431 Type II2007/06/12

SA070613 Fujifilm FCR Velocity U and DR Velocity UFP 35223 Type II2007/06/12

SA070614 Electric Mobility Rascal Power Chair and Turnabout Power Chair 34829 Type II2007/06/12

SA070615 Sendx Medical (Radiometer Capenhagen ) ABL80 Flex Analyzer 34820 Type II2007/06/12

SA070616 Biohorizons Implant Systems Complete OP & OS Surgical Kit 34533 Type II2007/06/12

SA070617 Bio-Rad Gelose MRSA Select REF63747, LOT7C1025 35132 Type II2007/06/12

SA070618 Invivo Precess (3160 Series) MRI Compatible Patient Monitoring System 2007/005/009/061/008 FSCA2007/06/12

SA070619 WALLACH T-00337 Anorectal Tip 2007/005/031/051/005 FSCA 2007/06/12

SA070620 BD Microtainer Safety Flow Lancets MDA/2007/049 MDA2007/06/12


MHRA

MHRA

MHRA

MHRA

Smiths Medical Level 1 H-1200 Fast Flow Fluid Warmer User and H-31B Air Detector/Clamp User MHRA

MHRA

Kensey Nash TriActiv FX Embolic Protection System, FX Spare Shieldwire Inflators, ProGuard Spare Shieldwire Inflators FDA

MHRA

MHRA

Health Canada

Health Canada

Health Canada

Health Canada

Health Canada

Health Canada

MHRA

MHRA

MHRA










http://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/list/rec-ret_md-im_date_apr-june_2007_e.html










SA070621 Boston Scientific SwissLithoclast Ultra Sound Handpiece Kit Boston Scientific(HK) Ltd N/A Firm Initiated Field Action2007/06/12

SA070622 Boston Scientific Impulse Angiographic Catheter Boston Scientific(HK) Ltd N/A Firm Initiated Field Action2007/06/12

SA070623 ev3 Amplatz Goose Neck Snare Kit 2007/006/006/061/023 FSCA 2007/06/13

SA070624 Wright Medical Profemur R, Revision Hip System Z-0867-2007 to Z-0868-2007 Class II 2007/06/14

SA070625 Surge Medical Solutions 15 Fr. Retrograde Cardioplegia Cannula Z-0892-2007 to Z-0904-2007 Class II2007/06/14

SA070626 Roche VANC2 Online TDM Vancomycin Z-0919-2007 to Z-0920-2007 Class II 2007/06/14

SA070627 Varian Medical FramelessArray Software version 1.0 Z-0905-2007 Class II2007/06/14

SA070628 Siemens Medical c.cam Gamma Camera, Model 9VIR1200 Z-0906-2007 Class II 2007/06/14

SA070629 Hawaii Medical NeatNick Sweeping Action Hell Lancet Z-0926-2007 to Z-0927-2007 Class II2007/06/14

SA070630 Sunrise Medical Groove Power Wheelchairs 2007/004/017/601/805 FSCA2007/06/14

SA070631 Schiller Easyport Defibrillators 2007/006/005/051/020 FSCA 2007/06/15

SA070632 B Braun Intrapur Neonat Lipid I.V. Filter 2007/006/012/061/008 FSCA2007/06/15

SA070633 Smith & Nephew PERI-LOC 2.5mm Self Tapping Locking Cortex Screw 2007/005/018/601/919 FSCA2007/06/20

SA070634 Boston Scientific Transend EX Guidewire Boston Scientific(HK) Ltd N/A Firm Initiated Field Action2007/06/20

SA070635 Biomet 3i EP Healing Abutment Z-0922-2007 Class II2007/06/21

SA070636 Biomet 3i disposable twist drills Z-0959-2007 Class II2007/06/21

SA070637 Synovis Peri-Strips Dry Staple Line Reinforcement Z-0960-2007 to Z-0965-2007 Class II 2007/06/21

SA070638 Porous Media HUMIDIFLOW Respiratory Gas Humidifier Z-0935-2007 Class II 2007/06/21

SA070639 Zoll Lifecor Electrode Belt Z-0936-2007 Class II2007/06/21

SA070640 Bio-Diagnostics GBM Quantitative ELISA Kit 2007/005/025/061/005 FSCA2007/06/21

SA070641 Thoratec TLC-II Portable VAD Driver 2007/006/013/061/001 FSCA2007/06/21

SA070642 Bausch & Lomb Zyoptix Epi Separator and Zyoptix XP Epi Head N/A Firm Initiated Field Action2007/06/21

SA070643 Smiths Medical Pneupac VR1 Ventilatory Resucitator 2007/003/029/601/731 FSCA 2007/06/22

SA070644 Sunrise Quickie 35442 Type II 2007/06/25

MHRA

FDA

FDA

FDA

FDA

FDA

FDA

MHRA

MHRA

MHRA

MHRA

FDA

FDA

FDA

FDA

FDA

MHRA

MHRA

Bausch & Lomb (Hong Kong) Ltd.

MHRA

Health Canada






















SA070645 Airox Legendair Ventilator Single/Double Bran 35427 Type I2007/06/25

SA070646 Walter Lorenz Bone File 35636 Type II 2007/06/25

SA070647 Beckman Coulter Flow Count Fluorospheres 35682 Type II 2007/06/25

SA070648 Beckman Coulter Cytomics FC 500 Flow Cytometer (CXP Version 2.1 and 2.2) 35691 Type II2007/06/25

SA070649 BD Multivisc 2.5% Viscoadaptive solution 34172 Type II 2007/06/25

SA070650 Inpeco Accelerator Aps System 35448 Type II 2007/06/25

SA070651 Oxoid Metronidazole 10ug disc 35291 Type II 2007/06/25

SA070652 Apex Hoy-advance-e 34534 Type II 2007/06/25

SA070653 Edwards Lifesciences Vigilance II Monitor 2007/006/013/061/012 FSCA 2007/06/25

SA070654 Horiba ABX Pentra Myoglobin CP Reagent, ABX Pentra Ferritin CP Reagent 2007/006/020/061/001 FSCA2007/07/26

SA070655 Fresenius Medical Care AV Set FMC (FA404E/FV404E) 2007/005/008/601/880 FSCA 2007/06/27

SA070656 Mediplus Coventry Valve Triple IV Peripheral Connector Set 2006/012/007/601/455 FSCA 2007/06/27

SA070657 Z-0950-2007 to Z-0953-2007 Class II2007/06/28

SA070658 Steris QFC1728 and QFC1729 Quick Connects Z-0967-2007 Class II 2007/06/28

SA070659 Roche MagNA Pure LC Total Nucleic Acid Isolation Kit Z-0956-2007 Class II2007/06/28

SA070660 Invacare Scanbed 750 (SB750) MDA/2007/056 MDA 2007/06/28

SA070661 Boston Scientific Capio Sutures Boston Scientific(HK) Ltd N/A Firm Initiated Field Action2007/06/28

SA070662 2007/006/026/291/010 FSCA2007/06/29

SA070663 Oasis Medical Premier Edge Disposable Knives 2007/006/026/291/013 FSCA2007/06/29

SA070664 Cyberonics VNS Therapy Leads (Model 300, 302, 303) Cyberonics N/A Firm Initiated Field Action2007/06/29

Health Canada

Health Canada

Health Canada

Health Canada

Health Canada

Health Canada

Health Canada

Health Canada

MHRA

MHRA

MHRA

MHRA

Abbott ARCHITECT i2000 Processing Module (List# 08C89-01, 3M74-01, 1G06-01 & 3L77-01) FDA

FDA

FDA

MHRA

Medtronic Biphasic LIFEPAK 500 AEDs MHRA

MHRA





















Local Agent

N/A N/A



BD 2575-8668





N/A N/A


Zenith Medical Co. Ltd 2720 2727


Fujifilm Hong Kong Limited 2317 0848

N/A N/A

N/A N/A

Specialists' Dental Supplies Limited N/A


N/A N/A

N/A N/A

BD 2575 8668





Conmed Ltd 2854 4413


N/A N/A




N/A N/A

N/A N/A

N/A N/A

N/A N/A



N/A N/A

N/A N/A

Suntime Technology Ltd 2758 8075

N/A N/A

N/A N/A

N/A N/A

N/A N/A

Bausch & Lomb (Hong Kong) Ltd. 2213 3178


N/A N/A


Forever Health Medical Instrument Ltd 2770 9922

N/A N/A



BD 2575 8668

N/A N/A

N/A N/A

N/A N/A

N/A N/A

N/A N/A

Fresenius Medical Care Asia Pacific Ltd. N/A

N/A N/A




N/A N/A



N/A N/A

GM Medical (Hong Kong) Ltd 2521 9799


Monthly Summary of Medical Device Safety Alerts - May 2007*Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada


SA070501 ResMed S8 CPAP Devices 2007/004/025/291/009 FSCA 2007/05/02

SA070502 Medi Prosthetic Knee Joint Z-0759-2007 Class II 2007/05/03

SA070503 Endoart EasyBand 2007/004/020/291/007 FSCA 2007/05/03

SA070504 Boston Scientific NexStentR Carotid Stent and Monorail Delivery System Boston Scientific (HK) Ltd N/A Firm Initiated Field Action2007/05/03

SA070505 Ortho- Clinical Diagnostics VITROS troponin I reagent packs (Cat. No.: 194 9882) N/A N/A2007/05/04

SA070506 2007/004/027/291/017 FSCA2007/05/07

SA070507 2007/003/030/601/744 FSCA2007/05/07

SA070508 Baxter UV Flash Compact Device 2007/005/002/061/009 FSCA 2007/05/09

SA070509 Hill-Rom AvantGuard Electtic Bed 2006/009/004/291/005 FSCA 2007/05/09

SA070510 BioMerieux BacT/ALERT Classic System Software, Blood Culturing System Z-0773-2007 to Z-0776-2007 Class II2007/05/10

SA070511 Toshiba Nemio XG, Ultrasound system SSA-590A with version 1.5 software Z-0771-2007 Class II2007/05/10

SA070512 B.Braun HyperFormer Pump Dispensing Set (Catalog No V9900-02) Z-0783-2007 Class II 2007/05/10

SA070513 Instrumentation Laboratory GEM Premier 4000 Laboratory Analyzer Z-0778-2007 Class II 2007/05/10

SA070514 Graham-Field Lumex Walkabout Lite Four-Wheel Rollator Z-0772-2007 Class II2007/05/10

SA070515 American Diagnostica Inc ACTICLOT Dpt Reference 824 in vitro diagnostic Z-0779-2007 Class II2007/05/10

SA070516 Tyco Healthcare SealGuard TracheoSoft and SealGuard TracheoSoft PERC 2006/011/016/291/003 FSCA2007/05/10

SA070517 2007/003/029/291/013 FSCA2007/05/10

SA070518 AFOS All endoscope storage facilities (ESF) MDA/2007/035 Medical Device Alert2007/05/11

SA070519 Olympus Flexible endoscopes MDA/2007/034 Medical Device Alert 2007/05/11

SA070520 Medtronic MiniMed insulin infusion pumps Medtronic International, Ltd. N/A Firm Initiated Field Action2007/05/11

SA070521 JCM Supportive seating system 2006/010/012/301/003 FSCA2007/05/11

SA070522 Thoratec - Paracorporeal ventricular assist device 34992 Type I2007/05/14


MHRA

FDA

MHRA

FDA

Beckman Coulter COULTER LH750 Analyzer, COULTER LH780, COULTER LH500 Series System, COULTER GEN.S MHRA

Smith & Nephew Reflection All Poly Acetabular Cup (Product Code 71353255 06DT97293) MHRA

MHRA

MHRA

FDA

FDA

FDA

FDA

FDA

FDA

MHRA

Edwards Lifesciences CO-Set + Closed Injectate Delivery System for Cold Injectate (Model 93600) MHRA

MHRA

MHRA

MHRA

Health Canada




http://www.fda.gov/oc/po/firmrecalls/orthoclinical05_07.html


















SA070523 Datex-Ohmeda TEC 6 Plus Desflurane Vaporizer 33552 Type II2007/05/14

SA070524 GE Healthcare Revolution XR/D 34525 Type II2007/05/14

SA070525 GE Medical System CIC Pro Central Station 34840 Type II 2007/05/14

SA070526 Conmed PET Eliminator Balloon Dilator 34868 Type II 2007/05/14

SA070527 AMG Medpro Lubricating Gel 34958 Type II 2007/05/14

SA070528 Stryker 3.5mm 90-S Serfas Energy Suction Probe 34918 Type II 2007/05/14

SA070529 Boston Scientific Maverick 2 Monorail Balloon Catheter Boston Scientific(HK) Ltd N/A Firm Initiated Field Action 2007/05/15

SA070530 Boston Scientific System Drape (IVUS motor drive sterile plastic cover) Boston Scientific(HK) Ltd N/A Firm Initiated Field Action2007/05/15

SA070531 Medical Wire and Equipment Customers Microrings 2007/005/003/061/014 FSCA2007/05/15

SA070532 Arjo Maxi Move Patient Lift with Scale Z-0796-2007 to Z-0799-2007 Class II 2007/05/17

SA070533 Ethicon Gynecare PROLIFT Total Pelvic Repair System Z-0795-2007 Class II2007/05/17

SA070534 CIBASoft Visitint Soft Contact Lenses Z-0793-2007 Class II2007/05/17

SA070535 Medtronic LIFEPAK 20 Defibrillator/Monitor 2007/005/002/061/006 FSCA2007/05/18

SA070536 Vygon V-GREEN Narrow Bore Ext Line with Clamp 2007/005/011/291/002 FSCA2007/05/18

SA070537 BD FACSCanto and FACSCanto II Software 2007/005/010/291/006 FSCA2007/05/18

SA070538 Olympus Clinical Chemistry Analyser Software version V5.3A 2007/005/010/061/013 FSCA 2007/05/18

SA070539 Olympus Triglyceride Reagent 2007/005/010/061/009 FSCA 2007/05/18

SA070540 2007/004/025/291/018 FSCA2007/05/18

SA070541 Conor Medsystems CoStar drug-eluting coronary stents N/A N/A 2007/05/18

SA070542 MDA/2007/039 Medical Device Alert2007/05/22

SA070543 Nightingale Pro Axis and Pro Axis Plus MDA/2007/038 Medical Device Alert 2007/05/22

SA070544 MEDEX DPS Kids Kit (Pediatric) Secure System 2007/005/016/291/014 FSCA 2007/05/22

SA070545 BREAS PV403 PEEP 2007/005/014/061/009 FSCA 2007/05/22

SA070546 Viasys all paediatric ventilator breathing systems containing water trap MDA/2007/037 Medical Device Alert2007/05/22

SA070547 Abbott FLEXIFLO DURA-PEG Kit 2007/005/014/061/019 FSCA 2007/05/23

SA070548 Cranex Tome panoramic x-ray unit Z-0816-2007 Class II 2007/05/25

Health Canada

Health Canada

Health Canada

Health Canada

Health Canada

Health Canada

MHRA

FDA

FDA

FDA

MHRA

MHRA

MHRA

MHRA

MHRA

DIAGMED ENTERAL Covered Duodenal Stent (Codes NDC-18-90-180 & NDC-18-110-180) MHRA

Johnson & Johnson

Homecraft Rolyan Bathmaster 2000, Bathmaster Classic, Bathmaster Xtra and Bathmaster Reclina (bath lift hand controls) MHRA

MHRA

MHRA

MHRA

MHRA

MHRA

FDA

















http://www.jnj.com/news/jnj_news/20070507_080915.htm;jsessionid=KWIM4J4HMUPOGCQPCAOWU3YKB2IIWTT1









SA070549 GE Americas Signa 3.0T EXCITE Whole Body Magnetic Resonance System Z-0815-2007 Class II2007/05/25

SA070550 BioMerieux BacT/VIEW Software, all versions. Z-0814-2007 Class II2007/05/25

SA070551 Diagnostic Stago STA Compact and STA Compact CT Z-0812-2007 Class II 2007/05/25

SA070552 Roche PTH (Parathyroid Hormone Test system ) Z-0810-2007 Class II 2007/05/25

SA070553 Sunrise Medical GROOVE 10KPH & 13 KPH Models Wheelchairs 2007/004/010/301/003 FSCA 2007/05/25

SA070554 Draeger Medical Primus anaesthetic workstation MDA/2007/040 Medical Device Alert 2007/05/25

SA070555 EXIDE Technologies Mentzer 24V 6A Konstant Charger 2007/002/001/301/001 FSCA 2007/05/25

SA070556 Abbott ARCHITECT STAT Troponin-I test products Abbott Laboratories Ltd. N/A Firm Initiated Field Action 2007/05/25

SA070557 AMO COMPLETE MoisturePLUS Multi-Purpose Solution N/A CDC 2007/05/28

SA070558 Roche COBAS Integra System Valproic Acid 34875 Type I 2007/05/28

SA070559 T.H.E. Medical Reacher Bar with Small Carabiner 34511 Type I 2007/05/28

SA070560 Randox Laboratories Assayed Bovine Serum 34276 Type II 2007/05/28

SA070561 B.Braun Ultrasite Horizon Pump IV Set 34874 Type II 2007/05/28

SA070562 Dentsply Protper Obturators 34652 Type II 2007/05/28

SA070563 35215 Type II2007/05/28

SA070564 Philips HD11 Ultrasound System 35094 Type II 2007/05/28

SA070565 Conmed Linvatec Medical Devices Packaged within certain Peel Pouch Sterile Packages 35032 Type II2007/05/28

SA070566 35003 Type II

2007/05/28

SA070567 BIODIS VerifyNow P2Y12 2007/003/026/291/004 FSCA 2007/05/29

SA070568 Medtronic Advantage Heart Valves A7760, A7760SA, M7760 Medtronic International, Ltd. N/A Firm Initiated Field Action2007/05/29

SA070569 BD Infusion Therapy System (Angiocath Catheter) BD N/A Firm Initiated Field Action 2007/05/29

SA070570 Z-0822-2007 to Z-0826-2007 Class II2007/05/31

SA070571 GE Medical Definium AMX 700 Digital mobile x-ray system Z-0821-2007 Class II 2007/05/31

SA070572 Abbott Precision Link Software (version 2.1 - 2.6) Z-0709-2007 Class II 2007/05/31

SA070573 CP Medical Surgical Suture Z-0807-2007 Class II 2007/05/31

SA070574 Corin Taper-Fit (12/14 Eurocone) Hip Stem 2007/005/022/061/006 FSCA 2007/05/31

FDA

FDA

FDA

FDA

MHRA

MHRA

MHRA

FDA

Health Canada

Health Canada

Health Canada

Health Canada

Health Canada

Philips Medical (1) Achieve 1.5T MRI System (2) Gyroscan Magnetic System ACS-NT (3) Gyroscan Magnetic System T10-NT (4) Intera 3.0T MRI System (5)Intera 1.5 Master MR Health Canada

Health Canada

Health Canada

Beckman (1) Synchro LX20Pro (2) Synchron LX20 System Analyzer (3) Synchron LXI725 (4) Unical DXC 600 (5) Unical DXC 6001 Analyzer (6) Unical DXC80. Health Canada

MHRA

Inverness Medical BinaxNOW (a) Influenza A&B 10 Test Kit (b) Influenza A&B 22 Test kit (c) RSV 10 Test kit (d) Nasopharyngeal Accessory pak (e) A&B Kit 10 Test kit (Japan) FDA

FDA

FDA

FDA

MHRA


























Local Agent

N/A N/A

N/A N/A

N/A N/A





Baxter Healthcare Ltd 28078556

N/A N/A


Sanko Medical Systems (H.K.) Ltd. 2384 0688


Vastec medical Ltd 2897 1912

N/A N/A

N/A N/A


N/A N/A

N/A N/A



N/A N/A

GM Medical Pacific Ltd 2783 1838






N/A N/A

N/A N/A




N/A N/A



Ciba Vision (Hong Kong) Ltd. 2814 2121


N/A N/A

BD 2575 8668



N/A N/A

Biotronik Hong Kong 2877 6787

N/A N/A

N/A N/A


N/A N/A

Viasys Healthcare Hong Kong Ltd 2893 0873


Umedco 2765 8222




N/A N/A


N/A N/A


GNB Technologies (China) Ltd N/A




N/A N/A

N/A N/A


N/A N/A



N/A N/A


N/A N/A


BD 2575 8668

N/A N/A



N/A N/A

N/A N/A


Monthly Summary of Medical Device Safety Alerts - April 2007*Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada


SA070401 Siemens Medical Solutions IMMULITE One TNF-Alpha Lot 147 (LKNF 147) 2007/003/028/601/729 FSCA 2007/04/02

SA070402 GE Healthcare OEC 9900 2007/003/029/181/004 FSCA 2007/04/03

SA070403 Smith & Nephew - Birmingham Hip Resurfacing Acetabular Cups 2007/002/006/081/001 FSCA 2007/04/03

SA070404 Baxter Haemodialysis Instruments Addenda 2007/003/016/291/002 FSCA 2007/04/04

SA070405 Arcomedical Infusion Ltd - 3101-PVJ (FSB502) Needlefree solution set (Batch C8227) 2007/003/022/601/706 FSCA 2007/04/04

SA070406 GE Healthcare Smart Box 32004 Type II 2007/04/10

SA070407 GE Healthcare Lightspeed VCT and Lightspeed VCT Select 33345 Type II 2007/04/10

SA070408 GE Healthcare - OEC Uroview 2800, OEC Miniview 6800, OEC Flexiview 8800 345,133,451,434,517 Type II 2007/04/10

SA070409 34484 Type II 2007/04/10

SA070410 GE Healthcare - Instatrak 3500 System 33329 Type II 2007/04/10

SA070411 Depuy Asr Acetabular Cup System 34519 Type II 2007/04/10

SA070412 Smiths Medical - Fluid Warming System 34536 Type II 2007/04/10

SA070413 Smiths Medical - Medfusion 3500 Syring Infusion Pump 34277 Type II 2007/04/10

SA070414 Siemens Medical - Lithoskop 34448 Type II 2007/04/10

SA070415 Conmed Padpro Adult Radiotranslucent Pad 34510 Type I 2007/04/10

SA070416 Trudell Medical Marketing Limited - ABG kit 34214 Type II 2007/04/10

SA070417 Stentor (Philips Medical Systems) - Isite Pacs 34305 Type II 2007/04/10

SA070418 Cryocath Flexcath Steerable Sheath 34518 Type II 2007/04/10

SA070419 Dentalez Inc - End Cup 34543 Type II 2007/04/10

SA070420 Physio-Control LIFEPAK 20 Defibrillator/Monitor Medronic International Ltd N/A Firm Initiated Field Action 2007/04/10


MHRA

MHRA

MHRA

MHRA

MHRA

Health Canada

Health Canada

Health Canada

GE Healthcare OEC Radiographic/Fluoroscopic Systems, Model (1) Mini6600 (2) Uroview 2800 (3) Miniview 6800 (4) Flexiview 8800 (5) 9800 Health Canada

Health Canada

Health Canada

Health Canada

Health Canada

Health Canada

Health Canada

Health Canada

Health Canada

Health Canada

Health Canada





















SA070421 Philips Medical - Brilliance Computed Tomography System 34499 Type II 2007/04/10

SA070422 Gambro Lundia AB - Prismaflex Cont. Rental Replacement System 33615, 33616 Type II 2007/04/10

SA070423 Ethicon Endo-Surgery PROXIMATE PPH hemorrhoidal circular stapler N/A N/A 2007/04/10

SA070424 Boston Scientific CONTAK RENEWAL 3 & 4 (CRT-D), VITALITY and VITALITY 2 (ICD) Boston Scientific(HK) Ltd N/A Firm Initiated Field Action 2007/04/11

SA070425 Remington Medical Prostate Biopsy needle Z-0673-2007 Class II 2007/04/11

SA070426 Intuitive brand Da Vinci S Surgical System Z-0670-2007 Class II 2007/04/11

SA070427 Aspyra Inc CyberMed Version 2.1 Pharmacy Software Z-0686-2007 Class II 2007/04/11

SA070428 NDO Surgical Plicator EPS Plication System Z-0685-2007 Class II 2007/04/11

SA070429 Zimmer Trabecular Metal Reserse Shoulder System Instrumentation Conical Reamer Z-0675-2007 Class II 2007/04/11

SA070430 Siemens syngo Dynamics 5.0 Workplace Z-0652-2007 Class II 2007/04/11

SA070431 Z-0647-2007 to Z-0651-2007 Class II 2007/04/11

SA070432 Terumo Perfusion System 8000 Base, Model 8000 Z-0655-2007 to Z-0659-2007 Class II 2007/04/11

SA070433 Cook ATB Advance PTA Dilation Catheter, REF G26887 Z-0665-2007 Class II 2007/04/11

SA070434 BD 366358 LANSCET SFL GREEN BD N/A Firm Initiated Field Action 2007/04/11

SA070435 2007/003/028/081/005 FSCA 2007/04/11

SA070436 Intuitive Surgical 8mm EndoWrist Bipolar Maryland Instrument Part Number: 400172-04 Z-0660-2007 Class II 2007/04/11

SA070437 Abbott Clinical Chemistry Phosphorus in vitro diagnostic (List no 7D71-30 and 7D71-20) Z-0722-2007 Class II 2007/04/12

SA070438 BD 30ml Syringe Luer-Lok tip Sterile (Reorder number 309650) Z-0719-2007 Class II 2007/04/12

SA070439 Abott CELL-DYN 3200 Dilutent / Sheath Reagent (List number 03H79-01) Z-0706-2007 Class II 2007/04/12

SA070440 Z-0714-2007 Class II 2007/04/12

SA070441 Cenorin ThermaSure Medical Device Drying Cabient series 130, 300 AND 1000 Z-0711-2007 to Z-0713-2007 Class II 2007/04/12

SA070442 Z-0705-2007 Class II 2007/04/12

SA070443 Scanlan International Mobin-Uddin Vein Holder (Catalog# 1001-761) Z-0701-2007 Class II 2007/04/12

SA070444 Urologix Microwave Delivery System 2.5-3.5 AND 3.0 -5.0 Z-0720-2007 to Z-0721-2007 Class II 2007/04/12

SA070445 Boston Scientific Percutaneous Track Kit with Amplaz Dilator and Sheath Kit Boston Scientific(HK) Ltd N/A Firm Initiated Field Action 2007/04/16

SA0704476 Boston Scientific ObtryxR Transoburator Mid-Urethral Sling System Boston Scientific(HK) Ltd N/A Firm Initiated Field Action 2007/04/16

Health Canada

Health Canada


FDA

FDA

FDA

FDA

FDA

FDA

Zimmer NexGen Complete Knee Solution Minimally Invasive Solutions MIS Technology Femoral Finishing Guid FDA

FDA

FDA

Smiths Medical Level 1 H-1200 H31-B Fast flow fluid warmer users and Level 1 H31-B Air Detector/ Clamp User MHRA

FDA

FDA

FDA

FDA

Integra Biotechnical ProWord Shoulder Postoperative Dressing and Cold Therapy System (Model number AR-1625) FDA

FDA

Radiometer America ABL800 FLEX Series analyzer with FLEXQ module-equipped with software version 5.2 to 5.27 FDA

FDA

FDA























SA0704476 Boston Scientific RigiflexT II- Single Use Achalasia Ballon Dilators Boston Scientific(HK) Ltd N/A Firm Initiated Field Action 2007/04/16

SA070448 HemoCue Glucose Systems 2007/033/019/291/006 FSCA 2007/04/16

SA070449 Abbott TDx/TDxFLx Methotrexate Reagent (List no 07A12-60) 2007/004/002/601/745 FSCA 2007/04/16

SA070450 LifeScan One Touch Ultra blood glucose test strips N/A N/A 2007/04/17

SA070451 2007/004/011/291/009 FSCA 2007/04/18

SA070452 Dade Bethring Syva Emit 2000 Phenobarbital Assay, 4D019UL, lot W6 2007/002/008/601/580 FSCA 2007/04/18

SA070453 All Shelhigh medical devices 2007/04/18

SA070454 Z-0747-2007 Class II 2007/04/19

SA070455 Roche CoaguChek Brand PT Test Strips Z-0737-2007 Class II 2007/04/19

SA070456 Roche COBAS Integra DIG, Digoxin Reagent (Cat# 20737836322) Z-0736-2007 Class II 2007/04/19

SA070457 Z-0734-2007 to Z-0735-2007 Class II 2007/04/19

SA070458 Bio-Rad tox/See Drug Screen Test Z-0733-2007 Class II 2007/04/19

SA070459 AMS DURA-II Distal Tips and Universal Tips (Product no 72009340 and 72009361) Z-702-2007 to Z-703-2007 Class II 2007/04/19

SA070460 Joerns Healthcare Sunrise Medical-Hoyer Advance Patient Lifts Z-0727-2007 Class II 2007/04/19

SA070461 Coloplast Sea-Clens Wound Cleanser (#11701-159-36, #1063) Z-0710-2007 Class II 2007/04/19

SA070462 2007/004/003/601/746 FSCA 2007/04/20

SA070463 2007/004/010/131/012 FSCA 2007/04/20

SA070464 AngioDynamics Starburst 25cm, Starburst XL 25cm and Starburst SemiFlex 25cm 2007/004/010/131/006 FSCA 2007/04/20

SA070465 ev3 SilverSpeed .010" Guidewire (Ref:103-0601-200) 2007/004/013/051/003 FSCA 2007/04/20

SA070466 Teleflex Medical Infant Nasal CPAP System 34613 Type II 2007/04/23

SA070467 GE Healthcare Infinia Gamma Camera 33213 Type II 2007/04/23

SA070468 Alcon LADAR6000TM Excimer Laser 34303 Type II 2007/04/23

SA070469 Medtronic U-Clip -Removal Tool 34068 Type II 2007/04/23

SA070470 2007/004/012/601/784 FSCA 2007/04/23

SA070471 Unomedical Drain-Fix 680M and 685M, Central Gard 667M and 668M , Epi-Fix 670M 2007/003/016/081/007 FSCA 2007/04/23

SA070472 Boston Scientific SypGlassT Light Source Boston Scientific(HK) Ltd N/A Firm Initiated Field Action 2007/04/23

SA070473 Varian OBI with cone beam computed tomography (Versions 1.2 and 1.3) N/A Firm Initiated Field Action 2007/04/23

SA070474 2007/004/017/601/800 FSCA 2007/04/24

SA070475 Miltex Stainless Steel Disposable Scalpel #22 Part No 4-422 Z-0767-2007 Class II 2007/04/27

SA070476 Bio-Logic-Ceegraph/Sleepscan Netlink Traveler Model 580-T2ASM2 Z-0761-2007 Class II 2007/04/27

SA070477 RITA Starburst XL, Starburst, Starburst MRI SemiFlex Z-0752-2007 to Z-0754-2007 Class II 2007/04/27

MHRA

MHRA

LifeScan United Kingdom and Ireland

BIOMET 3i Conical 17 Degree Angeled Abutment 4.1mm (D) x 2mm (H) (AC4217 Lot No 639098F-5) MHRA

MHRA

FDA

Ortho- Clinical Diagnostics VITROS Immunodiagnostics Products HBsAg Reagent Pack (Cat# 6801322) FDA

FDA

FDA

Roche AmpliChip CYP450 Test-US IVD-M/N:4591402190 & CYP 450 Test, CE-IVD, M/N4381866190 FDA

FDA

FDA

FDA

FDADade Bethring Microgenics MAS Controls Cardiolmmune XL Control (CAI-XL1. CAI-XL2, CAI-XL3, CAI-XL4) MHRA

Mckinley Medical MicroSet NDEHP with 1.2 flter and SR segment (Product code 120-112XSFV) MHRA

MHRA

MHRA

Health Canada


Health Canada

Abbott ARCHITECT i2000 and i2000 SR Systems (list no. 8C89-01 and 3M74-01) and Folate Reagents (List no. 7K60-20, 7K60-25, 7K60-30) MHRA

MHRA


AxSYM Total β - Hcg Reagent (List no. 7A59-21, 7A59-22, 1A06-22) and Speciment Diluent (List no. 9C21-50) MHRA

FDA

FDA

FDA



http://www.lifescaneurope.com/uk/diabetes/news/;jsessionid=FKLNXILWG44AACUCERDB0GQ



http://www.fda.gov/cdrh/safety/041807-shelhigh.html
























SA070478 Siemens Mobilett XP (Model number 1818454, 1818447, 1818363) Z-0749-2007 to Z-0751-2007 Class II 2007/04/27

SA070479 Z-0731-2007 to Z-0732-2007 Class II 2007/04/27

SA070480 BIO-RAD EVOLIS SYSTEMS 2007/004/016/121/001 FSCA 2007/04/27

SA070481 Gambro Lundia AB - Prismaflex Cont. Rental Replacement System 34562 Type I 2007/04/30

SA070482 Gambro Cartridge Blood Tubing 003409410 34726 Type II 2007/04/30

SA070483 Phillips Medical Voxel Q Field Upgrade to ACQSIM 34838 Type II 2007/04/30

SA070484 34787 Type II 2007/04/30

SA070485 Toshiba Aplio XV Ultrasound System 34318 Type II 2007/04/30

SA070486 Siemens Linear Accelerators, Digital Linear Accelerator and Oncor Impression IMRT 34725 Type II 2007/04/30

SA070487 Maquet HL30 Perfusion System 34587 Type II 2007/04/30

SA070488 Smiths Medical CADD Administration Sets and CADD Prizm Administration Sets 34794 Type II 2007/04/30

SA070489 Dade Behring BEP2000 ADV System Release Kit 1.23.3 34859 Type II 2007/04/30SA070490 Zerusa Guardian Hemostasis Valve FH100 34684 Type II 2007/04/30

SA070491 N/A N/A 2007/04/30

FDA

Sunrise Medical DeVibiss PD1000A Pulse Dose Oxygen Conserving Cylinder and 535D-X CF Continuous Flow Cylinder FDA

MHRA

Health Canada

Health Canada

Health CanadaBaxter Healthcare Colleague 3 Volumetric Infusion Pump, Colleague Guardian 3 CXE Color Pump, Colleague Volumetric Infusion Pump. Health Canada

Health Canada

Health Canada

Health Canada

Health Canada


西安西京醫療用品有限公司"希健醫用" Extracorporeal circulating set SFDA














http://www.sfda.gov.cn/cmsweb/webportal/W4291/A64020252.html



Local Agent




Baxter Healthcare Ltd. 2807 8556

N/A N/A










Conmed Limited 2854 4413

N/A N/A


N/A N/A

N/A N/A








N/A N/A

N/A N/A

N/A N/A

N/A N/A





BD 2575 8668


N/A N/A


BD 2575 8668


N/A N/A

N/A N/A

N/A N/A

N/A N/A

N/A N/A




(1) 2781 0232; (2) 2541 1041






N/A N/A

N/A N/A

N/A N/A

Healthcare Diagnositcs N/A





N/A N/A

N/A N/A

Coloplast (Hong Kong) Ltd 3628 7488

N/A N/A

N/A N/A

N/A N/A

CONMED LTD 2854 4413





N/A N/A




N/A N/A

N/A N/A

N/A N/A



N/A N/A










N/A N/AN/A N/A

N/A N/A


Monthly Summary of Medical Device Safety Alerts - March 2007*Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada

MDCO Ref. No. Description of Product Reference No. by Source Alert Type by Source

SA070301 Taut Intraducer Peritoneal Catheter Z-0428-2007 Class II 2007/03/01

SA070302 Z-0501-2007 Class II 2007/03/01

SA070303 Siemens Medical Solutions- Symbia S Series SPECT & SPECT-CT Z-0548-2007 to Z-0549-2007 Class II 2007/03/01

SA070304 Steris Corporation - Cmax Surgical Table Model No 2182625 Z-0554-2007 Class II 2007/03/01

SA070305 Arjo - Sara Active Sling, patient Lift Z-0424-2007 to Z-0426-2007 Class II 2007/03/01

SA070306 Edwards Lifescience - Aquarius Haemofiltration Machine 2007/001/025/081/004 Field Safety Corrective Action 2007/03/01

SA070307 BD - Sensi- Disc Ticarcillin (Cat# 231619; Lot# 6167435) BD N/A Firm Initiated Field Action 2007/03/01

SA070308 Kjaerulff Lift Stand Aid (art no: 400640434) 2006/09/006/401/013 Field Safety Corrective Action 2007/03/02

SA070309 AGFA - Impax 6.X DS3000, 5.1 and 5.2MA3000 34055 Type II 2007/03/05

SA070310 Olympus - PK7200 Microplate System (Software) 34196 Type II 2007/03/05

SA070311 Waverleyglen Systems Ltd - Portable Reacher 24" and 36" 34150 Type I 2007/03/05

SA070312 Hospira - Enteral Plumset with Integral Container 33456 Type II 2007/03/05

SA070313 Huntleigh Healthcare Contoura 880 beds 2006/011/027/291/008 Field Safety Corrective Action 2007/03/05

SA070314 Medtronic Ltd - GATEKEEPER Reflux Repair System Model 3770GK 2007/002/014/081/006 Field Safety Corrective Action 2007/03/06

SA070315 Pine Medical Rotating Waist Restraint N/A Alert to Hospital 2007/03/06

SA070316 Bausch & Lomb ReNu MultiPlus contact lens care solutions N/A Firm Initiated Field Action 2007/03/06

SA070317 Physio-Control LIFEPAK CR Plus and LIFEPAK EXPRESS defibrillators Medtronic International, Ltd. N/A Firm Initiated Field Action 2007/03/07

SA070318 Z-0521-2007 Class II 2007/03/08

SA070319 Z-0582-2007 Class II 2007/03/08

SA070320 Hospira - LifeShield Latex-Free Primary I.V. Pump Set (List 12163-01, lot 39-126-5H) Z-0542-2007 Class II 2007/03/08

SA070321 Z-0522-2007 Class II 2007/03/08

SA070322 Z-0550-2007 to Z-0553-2007 Class II 2007/03/08

Source of Information* Date of Issue (YYYY/MM/DD)

FDA

Abbott - Imx Sirolimns Reagent Pack (Lots# 053389, 053457, 063650, 063973, 064459, 064772, 064750, 065076) FDA

FDA

FDAFDA

MHRA

MHRA


Health Canada

Health Canada

MHRA

MHRA

Health Canada

Bausch & Lomb (Hong Kong) Ltd.

Stryker Tom Tessier Osseous Microtome: Plug for Bone Mill Systems (Parts 01-15400; 01-15401 & 01-15407) FDA

BD Integra 1ml Syringe with Retracting Guide Needle 1 ml 29g 1/2' (0.33 x 13mm) Re-Order No. 305282 U-100 insulin (Lot# 6073436) FDA

FDA

Exactech Optetrak All Poly Tibial PS Component, Knee prothesis catalog # 204-11-13, serial numbers 0900529 - 0900532 FDA

Clark Biocompatible Hemoperfusion Cartridge, Sorbent: Heparinized polymer over activated carbon, 50ml, 100ml, 175ml & 250ml (Lot # 564 - 577) FDA














http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/2007/pinel_nth-aah_e.html







SA070323 Z-0546-2007 Class II 2007/03/08

SA070324 Preservation Uni-Compartmental Knee fixed-bearing Tibial Tray Components (size 1 - 5 ) 2006/011/022/081/001 Field Safety Corrective Action 2007/03/08

SA070325 ULTIMA TPS femoral stem and ULTIMA Metal-on Metal articulation 2007/002/001/081/014 Field Safety Corrective Action 2007/03/08

SA070326 ConMed Frazier and Poole Suction Instruments 2006/011/023/081/011 Field Safety Corrective Action 2007/03/08

SA070327 KaVo. Dental Ltd. - QUATTROcare Spray Cans 2006/012/007/081/004 Field Safety Corrective Action 2007/03/08

SA070328 Umimplanted PRECISION Implantable Pulse Generators (IPGs) Boston Scientific (HK) Ltd N/A Firm Initiated Field Action 2007/03/09

SA070329 Timesco Optima XL Stubby Laryngoscope Handles 2006/012/001/291/002 Field Safety Corrective Action 2007/03/09

SA070330 Vygon Lectro Cath Plus 200 cm ext. Line (batch: 0623618A) 2007/003/001/181/002 Field Safety Corrective Action 2007/03/09

SA070331 Vygon Lectro Cath Plus150 cm ext. Line (batch: 0624291A) 2007/003/008/081/001 Field Safety Corrective Action 2007/03/12

SA0703322006/011/001/081/009

Field Safety Corrective Action 2007/03/13

SA070333 Beckman Coulter FP1000 Cell Preparation System 2007/003/006/081/015 Field Safety Corrective Action 2007/03/14

SA070334 MDA/2007/021 Medical Device Alert 2007/03/14

SA070335 Hamilton Medical Galileo Classic and Gold ventilators Hamilton Medical N/A Firm Initiated Field Action 2007/03/14

SA070336 Z-0578-2007 to Z-0579-2007 Class II 2007/03/15

SA070337 Z-0597-2007 Class II 2007/03/15

SA070338 Z-0577-2007 Class II 2007/03/15

SA070339 Z-0545-2007 Class II 2007/03/15

SA070340 Alcon Custom-Pak (Part# 10975-02; 2638-17; 4917-54; 6515-51; 11148-02) Z-0560-2007 to Z-0564-2007 Class II 2007/03/15

SA070341 Z-0567-2007 to Z-0573-2007 Class II 2007/03/15

SA070342 Abiocor AB5000 Console Circulatory Support System (Catalog no. 0015-000) Z-0574-2007 Class II 2007/03/15

SA070343 2007/003/007/601/661 Field Safety Corrective Action 2007/03/15

SA070344 Boston Scientific Carotid Wallstent endoprosthesis Boston Scientific (HK) Ltd N/A Firm Initiated Field Action 2007/03/15

LifeSync ECG System- Disposable Leadwear Ls-222, Ls-223 (Code C6310, C6324 and C6297) FDA

MHRA

MHRA

MHRA

MHRA

MHRA

MHRA

MHRA

VBM Medizintechnik GmbH - 13g Jet Ventilation Catheter Ref 30-02-013-1 and 30-02-913-1 MHRA

MHRA

Timesco Callisto Macintosh size 3 (adult) single-use laryngiscope blade (part # DS.3940.150.20/21) (Affected lots: GE, GF, GG, GH, GI, GJ, GK, GL, HA) MHRA

Siemens Medical Solutions AXIOM Artis MP, Angiographic x-ray system (model number 5904466& 7555365) FDA

Kensey Nash Corp. - ThromCat Thrombectomy Catheter System 7F2.5-7.0MM 150CM (Lot#54877, 55318, 55218, 54821) FDA

EKOS EndoWave Infusion System and EKOS Lysus Infusion System (All models with Serial no. greater than and equal to 0610XXXX-XXX) FDA

Siemens Medical Solutions Sample Management System Software for in vitro diagnostic testing Product # 030102-03 FDA

FDA

Wright Medical Technology Gladiator Bipolar Hip Prothesis (REF: GLBP-2241; GLBP-3650; GLBP-3651L GLBP-3652; GLBP-3653; GLBP-3654; GLBP-3655) FDA

FDA

Arcomedical Ltd - 3101-PN3 (FSB890) Solution Set, No Y site 3, length tubing (batches C8237) MHRA





http://83.98.30.20/home/idcplg?IdcService=SS_GET_PAGE&useSecondary=true&ssDocName=CON2030446&ssTargetNodeId=967
















SA070345MDA/2007/023

Medical Device Alert 2007/03/16

SA0703462007/003/012/081/010


SA070347 B. Braun Medical Ltd - MANDRIN/STYLET INTROCAN2007/003/013/081/005


SA0703482007/003/012/601/683


SA070349 Gyrus ACMI Tripolar Ultra Cutting Foreceps (Ref no. TRU5-32, 006689-901, 006689-903) Z-0613-2007 to Z-0615-2007 Class II 2007/03/21

SA070350 Remel MacConkey Agar w/Sorbitol, growth medium, catalog R01556 (Lot#506069) Z-0621-2007 Class II 2007/03/21

SA070351 StayFix Fixation Device (REF 680ME, REF 685ME, REF670M) Z-0629-2007 Class II 2007/03/21

SA070352 Z-0637-2007 Class II 2007/03/21

SA070353 iSight PACS version 3.5 Z-0616-2007 Class II 2007/03/21SA070354 Abbott -CELL-DYN 4000 Diluent/Sheath Reagent (List#01H73-01) Z-0639-2007 Class II 2007/03/21

SA070355 Manual Drive Unit for Sarns (Terumo) Centrifugal Perfusion System (Catalog # 164268) Z-0617-2007 Class II 2007/03/21

SA070356 34385 Class II 2007/03/21

SA070357 Haemodialysis Machine: Integra manufactured by Gambro MDA/2007/027 Medical Device Alert 2007/03/21


SA070359 Arcomedical Infusion Ltd - 3110-J (FSB499) Burette Set (Batch H24563) 2007/003/015/601/689 Field Safety Corrective Action 2007/03/21

SA070360 Biomerieux BacT/ALERT FN Culture Bottle (Product no 259793, lot no 1015145) 2007/003/001/601/640 Field Safety Corrective Action 2007/03/21

SA070361 Maquet Cardiopulmonary AG - Product Code H7101 (Lot 218333, 221734, 223245) 2007/002/022/291/001 Field Safety Corrective Action 2007/03/21

SA070362 Karma Mobility - Martin (KM-8520 series) 2006/003/014/291/019 Field Safety Corrective Action 2007/03/21

SA070363 Clearview Simplify D- Dimer( Kit lot no. PX018A, Batch no 682-024) Z-0594-2007 Class II 2007/03/21

SA070364 BD N/A Firm Initiated Field Action 2007/03/21

SA070365 Boston Scientific Expo Selective Angiographic Catheter Boston Scientific(HK) Ltd N/A Firm Initiated Field Action 2007/03/22

SA070366 N/A Firm Initiated Field Action 2007/03/22

SA070367 Medicare Technology 716 Wheelchair Lap Belt 2006/009/019/181/013 Field Safety Corrective Action 2007/03/26

SA070368 Smith & Nephew InterTan Subtrochanteric Lag Screw Driver (Product Code: 71674068) 2007/001/017/291/001 Field Safety Corrective Action 2007/03/26

SA070369 GE Healthcare OEC 9800 2006/010/013/291/005 Field Safety Corrective Action 2007/03/26

SA070370 Zeiss Reusable Sensor 2PS20 or EPS01 used with Pentasys Phacoemulsificator 2007/001/016/081/010 Field Safety Corrective Action 2007/03/26

Boston Scientific Ltd: Vitality and Assure implantable cardioverter defibrillator (ICD) families and Contak Renewal cardiac resynchronisation therapy defibrillator (CRT-D) Families MHRA

Smith & Nephew RF DENERVATION PROBE (ITEM CODE 7210271; DESCRIPTOR 10 CM, LOT# 602561) MHRA

MHRA

Abbott - AxSYM Toxo LgG (List no 9K08-20; Lot no 42249HN00, 42249HN01, 43528HN00, 43528HN01) MHRA

FDA

FDAFDA

Cook Triple Lumen Central Venous Catheter Tray with Cook Spectrum Glide Antimicrobial Catheter with EZ--Pass Hydrophilic Coating (Recorder no. C-UTLMY-701J-RSC-ABRM-HC-FST-A)

FDA

FDAFDAFDA

Baxter Healthcare Corp - Clearlink Paclitaxel IV Admin Set and Interlink Paclitaxel IV Admin Set Health Canada

MHRADePuy ASR Taper Sleeve Adaptor 9/10 (-3) and DePuy ASR Taper Sleeve Adaptor (Code no 999800313 and 999800300) MHRA

MHRA

MHRA

MHRA

MHRA

FDABD human IL-15 recombinant protein (Mat. No. 554630) and recombinant soluble dimeric human HLA-A2:Ig (Mat. No. 551263)

Varian FastPlan treatment planning system for stereotactic radiosurgery (versions 5.1 and below)


MHRA

MHRA

MHRA

MHRA

























SA070371 BD Vacutainer Safety-Lock Blood Collection Set with Pre-Attached Holders BD N/A Firm Initiated Field Action 2007/03/27

SA070372 Puritan Bennett 840 Ventilator System 2007/003/021/081/002 Field Safety Corrective Action 2007/03/28


SA070374 Boston Scientific Polarcath Peripheral Dilatation System Inflation Unit Boston Scientific (HK) Ltd N/A Firm Initiated Field Action 2007/03/29

SA070375 Viasys VELA Ventilator Z-0638-2007 Class II 2007/03/29SA070376 BioMerieux BacT/ALERT FA Culture Bottles Z-0643-2007 Class II 2007/03/29

SA070377 Z-0644-2007 Class II 2007/03/29

SA070378 Gebauer - Salivart Oral Moisturizer Z-0497-2007 Class II 2007/03/29

SA070379 Immucor Gamma Capture-R Select plates 2007/001/002/291/001 Field Safety Corrective Action 2007/03/29

SA070380 CPS Direct SL slittable outer guide catheter 2007/003/021/081/003 Field Safety Corrective Action 2007/03/29

SA070381 Arcomedical Ltd - 3101PNOY (FSB542) (Batch number C7944) 2006/009/029/401/001 Field Safety Corrective Action 2007/03/30

SA070382 HoMedics Thera-P Heating Pads Z-0622-2007 to Z-0626-2007 Class I 2007/03/30

MHRAArcomedical Ltd - 3101-PN3 (FSB890) Solution Set, No Y site 3, length tubing (batches C8218) MHRA

FDAFDA

BioMerieux BacT/VIEW C.30 a Software update (P/N 514515-1) diagnostic data management system FDA

FDAMHRA

MHRA

MHRAFDA













Local Agent

N/A N/A



N/A N/A


N/A N/A

BD 2575 8668

N/A N/A


United Tecnica Limited N/A

N/A N/A

N/A N/A

N/A N/A


N/A N/A

Bausch & Lomb (Hong Kong) Ltd. 2213 3176

Medronic International Ltd 2919 1362


BD 2575 8668

N/A N/A

N/A N/A

N/A N/A



N/A N/A


DePuy Inc (J&J) 2738 2894

N/A N/A

N/A N/A


N/A N/A

N/A N/A

N/A N/A

N/A N/A


N/A N/A

N/A N/A


N/A N/A

N/A N/A




N/A N/A

N/A N/A





N/A N/A


N/A N/A

N/A N/A

N/A N/A

Philips Electronics Hong Kong Ltd. 2876 7525Abbott Laboratories Ltd. 2806 4201


Baxter Healthcare Ltd 2807 8556Gambro China Ltd. 2576 2688

DePuy Inc (J&J) 2738 2894

N/A N/A



N/A N/A

N/A N/A

BD 2575 8668



N/A N/A



N/A N/A


(1) 2781 0232; (2) 2541 1041


BD 2575 8668


N/A N/A


Viasys Healthcare Hong Kong Ltd 2893 0873Biomerieux (Hong Kong) 2356 7033


N/A N/A

N/A N/A

N/A N/A

N/A N/A

N/A N/A


Monthly Summary of Medical Device Safety Alerts - February 2007*Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada


SA070201 Z-0341-2007 to Z0342-2007 Class II 2007/02/01

SA070202 Z-0350-2007 Class II 2007/02/01

SA070203 Diagnostic Chemicals Ltd. - Salicylate - SL, in vitro diagnostic, Cat. No 511-20 (Lot#29892) Z-0361-2007 Class II 2007/02/01

SA070204 Z-0362-2007 Class II 2007/02/01

SA070205 Electronic Otto Bock Compact leg prosthesis System, 3C95/3C85 Z-0363-2007 Class II 2007/02/01

SA070206 Z-0364-2007 Class II 2007/02/01

SA070207 Z-0365-2007 Class II 2007/02/01

SA070208 Z-0366-2007 to Z-0371-2007 Class II 2007/02/01

SA070209 GE Centricity PACS RA 1000 Workstation (Version 2.1.X.X. and 3.0.X.X.) Z-0373-2007 Class II 2007/02/01

SA070210 Bio-Rad D-10 Dual Program Calibrator Diluent Z-0376-2007 Class II 2007/02/01

SA070211 Z-0377-2007 Class II 2007/02/01

SA070212 SypGlassT Lightcable, SypGlassT Camera, SpyGlass T Ocular and SpyGlassT Probe Boston Scientific (HK) LtdN/A

Firm Initiated Field Action 2007/02/02




SA070216 MHRA 2007/001/031/121/003 Field Safety Corrective Action 2007/02/07

SA070217 Varian Medical - CT/MR Ring & Tandem Applicator Set 33352 Type II 2007/02/07

SA070218 Toshiba - Aquilion m/s (Model or Catalog # TSX-101A/7) 32880 Type II 2007/02/07

SA070219 Walter Lorenz- 2" QC Solid Shaft Extention 33542 Type II 2007/02/07


Cyberonics VNS Therapy System, Model 250-'HAND HELD' programming software v6.1, v6.1.7, v7.0, v7.1.3 & 2500-'Handhelds' preprogrammed with software v6.0, v6.1, v6.1.7, v7.0, v7.1.3

FDA

Maquet - Jostra Heater Cooler Unit HCU30, System version 1.02- Low voltage machin, Article no.: 0704629 (serial no. 101006 - 101024) FDA

FDA

Suros Surgical ATEC Breast Biopsy System handpiece for use with ATEC Breast Biopsy and Excision System, disposable, sterile, Part no. 0912-20 (Lot: 611018) FDA

FDA

Abbott - i-STAT PT/INR Cartridge prothrombin time rest in vitro diagnostic (product list#04J50-01 & 04J50-02; catalog# 420200; Ref.: 04J50-01 24) FDA

Terang Nusa Sterile Neolon 2G Latex-Free Powder-Free Neoprene Surgical Gloves (Item no. MDS207060) FDA

Philips Integris Allura System angiographic- Allura 9 F/C, Allura Mono X-Ray System, Allura FD 10 FX, Allura FD20 x-ray, FD 10/10 x-ray system and FD 20/10 x-ray system FDA

FDA

FDA

Cook Flexor DL Dual Lumen Ureteral Access Sheath with AQ Coating, sterile REF FUS-095013-DL FDA

Heartsine Technologies Ltd - Defibrillators, Non implantable - Samaritan AED Models SAM-001, SAM-002 and SAM-003 MHRA

BOC Ltd - AZ size aluminium medical nitrous oxide cylinders fitted with a key operated pin index valve for use in MRI units MHRA

Lucas external cardiac compressor, manufactured by Jolife AB and distributed by Medtronic Ltd MHRA

GE Healthcare - Computed tomography - LightSpeed VCT - Discovery VCT - LightSpeed Pro32 - LightSpeed Pro 16 - LightSpeed RT16/ LightSpeed Xtra

Health Canada

Health Canada

Health Canada



















SA070220 Spacelabs Medical - Ultraview SL Command Module (Model/Catalog#91496) 33638 Type II 2007/02/07

SA070221 GE Healthcare - Innova 2100 IQ 33717 Type II 2007/02/07

SA070222 Fisher and Paykel Healthcare - Infant Evaqua Breathing Circuits 33803 Type II 2007/02/07

SA070223 Tyco Healthcare- CT9000 ADV with Console 33834 Type II 2007/02/07

SA070224 33570 Type I 2007/02/07

SA070225 Misys Healthcare System Version 6.1 and 6.2 32993 Type II 2007/02/07

SA070226 VISX Incorporated - Wavescan Wavefront System (Model/Catalog HS-1) 33201 Type II 2007/02/07

SA070227 33350 Type II 2007/02/07

SA070228 Siemens AG - Magneton Trio (Model: 7387074) 33837 Type II 2007/02/07

SA070229 Toshiba - Digital Fluorography System (Model or Catalog # DFP-8000D) 33121 Type II 2007/02/07

SA070230 Z-0381-2007 Class II 2007/02/08

SA070231 Z-0393-2007 to Z-0394-2007 Class II 2007/02/08

SA070232 Z-0374-2007 to Z-0375-2007 Class II 2007/02/08

SA070233 Rhytec, Inc - Portrait PSR3 System Z-0397-2007 Class II 2007/02/08

SA070234 N/A Press Release 2007/02/08

SA070235 Baxter Healthcare - Amicus Apheresis Kits F4R2337 (Lot#A06129053) 2007/002/005/291/011 Field Safety Corrective Action 2007/02/08

SA070236 Boston Scientific - Urgent Medical Device Recall - Immediate Action Required: Matrix 2 Boston Scientific (HK) Ltd Firm Initiated Field Action Field Safety Corrective Action 2007/02/09

SA070237 Medtronic - Spinal Implants - Colorado 2 Anterior Plates # 8639500 & #8619500 2007/002/006/291/007 Field Safety Corrective Action 2007/02/12




SA070241 Invacare C800 Series ceiling track MDA/2007/016 Medical Device Alert 2007/02/13

SA070242 Medtronic - Vitatron T and C pacemakers 2007/002/001/081/008 Field Safety Corrective Action 2007/02/14

SA070243 Z-0415-2007 to Z-0416-2007 Class II 2007/02/15

Health Canada

Health Canada

Health Canada

Health CanadaBiomerieux - Vironostika HIV-1 Microelisa System (Model/Catalog#259605; Lot/Serial#160354) Health Canada

Health Canada

Health Canada

Dentalez Inc. Stardental Division - Solara Replacement Turbine (Model/Catalog#263739, Lot#170510) Health Canada

Health Canada

Health Canada

Terumo Advance Perfusion System 1 Integrated Centrifugal System Control Unit (Catalog#801046) FDA

Bard Peripheral Vascular Inc - G2 Filter System - Jugular/Subclavian Delivery kit (Catalog# RF-320J & RF-220J) FDA

Davol Salute Fixation System 38cm and 18cm Resusable Shaft with Handle (Ref#113036/9113036 and 0113037/9113037) FDA

FDA

Custom Ultrasonics Inc - Stop manufacturing and distributing System 83 Plus Water/Disinfector and System Plus 83 Mini-Flex Washer/Disinfector FDA

MHRA

MHRA

Abbott - StarClose Vascular Closure System (Catalogue# 14677; Lot # 43034-6H to 47139-6H) MHRA

Bayer - Benzodiazepine Reagent Lot 56510483 used with ADVIA 1200, 1650, 1800 and 2400 Chemistry System MHRA

Smiths Medical Level 1 normothermic IV Fluid administration set (Catalogue # DI-60HL) (NHS Supply Chain code FFF265) MHRA

MHRA

MHRA

Abbott - ARCHITECT i2000 Processing Module (List#08C89-01 & 3M74-01; Temp Controller Board Par#78560-109&7856-109) FDA

























SA070244 Z-0399-2007 to Z-0400-2007 Class II 2007/02/15

SA070245 Cytomics FC500 and FC500 MPL with CXP Software version 2.0 & 2.1 Z-0418-2007 to Z-0420-2007 Class II 2007/02/15

SA070246 Perry-Kolberg Tiatanium Motility/Support System (Model 100045) (Lot# M-50021) Z-0396-2007 Class II 2007/02/15

SA070247 Welch Allyn PIC50 External Defibrillator/ Monitor MDA/2007/017 Medical Device Alert 2007/02/15

SA070248 Draeger Infinity monitor with Infinity docking station(IDS) MDA/2007/018 Medical Device Alert 2007/02/15

SA070249 GE Healthcare - Ventilator - Engstom Ventilator 2007/002/008/601/579 Field Safety Corrective Action 2007/02/15

SA070250 Thoratec Corporation - thoratec VAD Dual Drive Console 2007/002/005/081/012 Field Safety Corrective Action 2007/02/15

SA070251 Ascent Healthcare Solutions - AutoSuture Bladed Trocar (Model # 179094) Z-0414-2007 Class II 2007/02/15

SA070252 Belcher Pharmaceuticals Inc - Mucotrol Conc. Oral Gel Wafer contained in HDPE Bottle Z-0398-2007 Class II 2007/02/15

SA070253 Fisher and Paykel Healthcare - Cosycot Infant Warmer 33376 Type II 2007/02/21

SA070254 Wilson-Cook Medical, Inc. - Quantum Biliary Dilation Balloon 33986 Type II 2007/02/21

SA070255 Medex Inc. - Pressure Transducer Cartridge 33633 Type II 2007/02/21

SA070256 33908 Type II 2007/02/21

SA070257 Philips Medical System - Brilliance CT Big Bore System, Main Unit 33815 Type II 2007/02/21

SA070258 33905 Type II 2007/02/21

SA070259 Linvatec - E9000 Bur Products and Ultrapower Bur Products 33634 Type II 2007/02/21

SA070260 Skytron - Infinity Series Surgical Lights 33902 Type II 2007/02/21

SA070261 33870 Type II 2007/02/21

SA070262 32633 Type II 2007/02/21

SA070263 GE Healthcare - Precision 500D (Model/Catalog#S0915KE, S0915KF) 32382 Type II 2007/02/21

SA070264 33595 Type II 2007/02/21

SA070265 Williams Medical Suppliers Plc - Comfisound (Code: D52208, D52209, 69.2100) 2007/002/014/401/013 Field Safety Corrective Action 2007/02/21

SA070266 American medical System- AMS700 Penile Prosthesis (Part no: 72402987; Lot 475485004) 2007/002/015/081/004 Field Safety Corrective Action 2007/02/21


Stryker - Triathlon X3 CR Tibial Bearing Insert for Knee prosthesis size # 2-11MM & 7-11MM (Ref# 5530-G-211 2011-09 & 5330-G-711 2011-09) FDA

FDA

FDA

MHRA

MHRA

MHRA

MHRA

FDA

FDA

Health Canada

Health Canada

Health Canada

Adaltis Inc. - Detect-HCV V.3 (Model/Catalog# HCA-702B; Lot/Serial# 6770192, 6770192F) Health Canada

Health Canada

Resonant Medical Inc. - Restitu U/S Guide & Restitu U/S-SIM (Model# 9100-00015-2 & 9100-00015-1) Health Canada

Health Canada

Health Canada

Cardinal Health - Custom Sterile Cardiovascular Packs (Model/Catalog#SCV30OHXXX, SCV30PCXXX) (Lot/Serial#769528, 781014, 778976, 787188) Health Canada

GE Healthcare - Precision RX/I Fluoroscopic X-Ray System (Model/Catalog#S1303JJ/JK/JL/JM) Health Canada

Health Canada

Ortho- Clinical Diagnostics - Fetalscreen Test for D(RHO) Positive Fetal Red Blood Cells (Model/Catalog#780540) (Recall#33595) Health Canada

MHRA

MHRA

Smith&Nephew - Peri-Loc Lateral- Proximal Locking Plate, Right (Product codes: 71800508 & 71800513) (Lots# 06CM17723 & 06CN15086) MHRA


























SA070268 Candela - Vbeam/Aesthetica, Platiunum and Perfecta model laser systems 2007/001/029/081/010 Field Safety Corrective Action 2007/02/21

SA070269 Cardinal Health - Alaris Div -Syringe pumps (Signature Edition) 2006/008/029/081/009 Field Safety Corrective Action 2007/02/21


SA070271 Durex Canada - Confirm Clearly Smart Pregnancy Test 34026 Type II 2007/02/21

SA070272 SonoSite Inc (UK Rep) - LAP/12-5MHz Laparoscopic Transducer 2007/002/020/291/011 Field Safety Corrective Action 2007/02/21

SA070273 Makro Medical - MAKROMED URINE TEST STRIPS - all models 2007/001/023/081/007 Field Safety Corrective Action 2007/02/22

SA070274 Clearview Simplify D- Dimer( Product code 505285; Kit Lot numbers: PT030A & PT031A) 2007/002/020/291/014 Field Safety Corrective Action 2007/02/26

SA070275 Abbott - ARCHITECT FREE T3 Reagent (List # 7K63-20, 7K63-25, 7K63-30) 2007/002/019/601/608 Field Safety Corrective Action 2007/02/26

SA070276 Intavent Orthofix Ltd - Flexible size 2.5 Laryngeal Masks (REF 7125R and 7125DR) 2007/002/013/081/009 Field Safety Corrective Action 2007/02/27


MHRA

MHRA

Conmed DetachaTip endoscopic Multiple use grasper and disposable hand held graspers and dissectors (Ratcheted and non-ratcheted) MHRA

Health Canada

MHRA

MHRA

MHRA

MHRA

MHRA

Bausch & Lomb - TSV 25 Gauge High-Speed Cutter (Catalog no CX5825) & TSV 25 Gauge High-Speed Posterior Vitectomy Pack (Catalog nos CX4925 & CX4925A) MHRA













Local Agent

N/A N/A

Maquet Hong Kong Limited2393 9511

N/A N/A

N/A N/A

Otto Bock Hong Kong 2598 9772


N/A N/A




Boston Scientific 2960 7128

N/A N/A

2372 2288



Varian Medical Systems Pacific Inc. 2724 2836Sanko Medical System (HK) Ltd 2384 0688

N/A N/A


(1) Cook Asia (Hong Kong) Ltd. (2) A.R. Burkhill & Sons (Hong Kong) Ltd.

(1) 2781 0232; (2) 2541 1041

BOC Gases, Hong Kong Oxygen & Acetylene Co Ltd (HKO)


Schmidt BioMed Tech (HK) Ltd 2620 8310


Tokibo Co. (Hong Kong) Ltd 2418 9698



N/A N/A

VISX Incorporated (HK) N/A

N/A N/A




N/A N/A

N/A N/A

N/A N/A

N/A N/A



Medtronic International Ltd 2919 1362


Bayer Healthcare Ltd (Hong Kong) 2814 4829


Direct Health Ltd 2528 1109

Medtronic International Ltd 2919 1362





N/A N/A

Welch Allyn N/A



N/A N/A

N/A N/A

N/A N/A

Tokibo Co. (Hong Kong) Ltd. 2418 9698

N/A N/A

Smith Medical (S.E. Asia) Ltd. 23170988

Adaltis Healthcare (HK) Ltd 3123 8000


N/A N/A

N/A N/A

N/A N/A

N/A N/A




N/A N/A

Cemma Enterprise Co Ltd 2412 2310

Smith & Nephew Healthcare Ltd.

2645 8730


N/A N/A

N/A N/A

N/A N/A

SSL Healthcare Asia Ltd 2528 6778

N/A N/A

N/A N/A

N/A N/A


N/A N/A

N/A N/A


Monthly Summary of Medical Device Safety Alerts - January 2007*Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada


SA070101 Terumo Advanced Perfusion System 1, Model 801763; Model 801764 Z-0306-2007 & Z-307-2007 Class II 2007/01/03

SA070102 Z-0309-2007 & Z-310-2007 Class II 2007/01/03

SA070103 Solara Replacement Turbine, Autochuck End Cap, for dental handpiece, part no, 064900 Z-0313-2007 Class II 2007/01/03

SA070104 Terumo Advanced Perfusion System 1, Model 801763; Model 801764 Z-0314-2007 & Z-0315-2007 Class II 2007/01/03

SA070105 Z-0316-2007 Class II 2007/01/03

SA070106 Sorin Group Venous Femoral Catheter Wire Reinforced 2006/012/012/081/008 Field Safety Corrective Action 2007/01/04

SA070107 Siemens Medical Solutions Mammomat 1000 and Mammomat 3000/Nova 2007/001/003/081/001 Field Safety Corrective Action 2007/01/04

SA070108 GE Healthcare Technologies (Prev Datex Ohmeda) Aisys 2006/010/023/601/367 Field Safety Corrective Action 2007/01/04

SA070109 Siemens AG Magicsas/Sienet IWM 33372 Type II 2007/01/08

SA070110 Smiths Medical ASD Inc. Bivona Laryngectomy Tube, Long (Lot 1263830) 33320 Type II 2007/01/08

SA070111 LifeScan One Touch Ultra/Basic/Profile Blood Glucose Test Strips Z-0266-2007 Class I 2007/01/10

SA070112 Bard Composix Kugel Large Sized Patches Class I 2007/01/10SA070113 Terumo Advanced Perfusion System 1, Model 801041; Model 801040 Z-0292-2007 & Z-0293-2007 Class II 2007/01/10SA070114 Philips Medical Systems HeatStart FR2+ Defibrillator, Z-0308-2007 Class II 2007/01/10SA070115 Terumo Advanced Perfusion System 1 Z-0322-2007 & Z-0337-2007 Class II 2007/01/10

SA070116 Z-0338-2007 Class II 2007/01/10

SA070117 Z-0339-2007 Class II 2007/01/10

SA070118 Z-0440-2007 to Z-0443-2007 Class II 2007/01/10

SA070119 Z-044-2007 Class II 2007/01/10

SA070120 Bayer Advia 70 Hematology Analyzer, Drew Excell 22 Hematology Analyzer Z-0448-2007 & Z-0449-2007 Class II 2007/01/10

SA070121 Abbott Laboratories, Inc. Phenobarbital-Reagent-Clinical Chemistry, List no. 1E08-20 Z-0454-2007 Class II 2007/01/10


FDA

Endologix Infrarenal Bifurcated Powerlink System with Visifiex Delivery System (endovascular graft). Model No, 25-16-155BL FDA

FDA

FDA

Posterior Acetabular Retractor-Left with Light Cord Bracket, Model #BIO-1-1050-A, Posterior Acetabular Retrator-Right with Light Cord Bracket, Model #BIO-1-1050-A, packaged 1 retractor (left or right retractor) per plastic bag

FDA

MHRA

MHRA

MHRA

Health Canada

Health Canada

FDA

FDAFDAFDAFDA

Edwards LifeSciences-Swan-Ganz, Thermodilution Venous Infusion Port(VIP) Catheter with AMC Throboshield (An Antimicrobial *Heparin Coating), Ref: 831HF75, Model 831FH75

FDA

Smiths Medical ASD Inc. Bivona Laryngectomy Tube, ID 8.5mm, O.D. 11mm Length 88mm, TTS 11.8mm FDA

Smith & Nephew Trufit CB Plug Size Codes: Red, 7mm (Part #605-001-03, Blue, 9mm (Part #605-001-05); TruFit BGS Plug Size Code Red, 7mm (Part #600-001-03), Blue 9mm (Part#600-001-05)

FDA

Puritan Bennett KngithStar 330 Bi-Level Ventilator, Catalogue No. Y-KS330-NA. Y-KS330-SD, DSY-KS330-NA, DSY-K5330-SD, DLY-KS330-NA & DLY-KS330-SD FDA

FDA

FDA












http://www.fda.gov/medwatch/safety/2007/safety07.htm#Composix

http://www.fda.gov/bbs/topics/enforce/2007/ENF00986.htm










SA070122 Z-0466-2007 Class II 2007/01/10

SA070123 Shenzhen Bestman Instrument Media Injectors (X-ray) contrast medium syringe 2006/011/022/401/015 Field Safety Corrective Action 2007/01/10

SA070124 Corybros Ltd - CB3600 2006/010/002/601/324 Field Safety Corrective Action 2007/01/10

SA070125 33715 Type II 2007/01/16

SA070126 Stryker - Howmedica Hip Fracture Stem System Z-0472-2007 to Z-0476-2007 Class II 2007/01/17

SA070127 SPS Blue Line Tube Clamp Adapters, Product number BL120M Z-0445-2007 Class II 2007/01/17

SA070128 Viasys V.P.I. Bird Gold pediatric ventilator, catalog no. 15653 and 15654 Z-0480-2007 to Z-0481-2007 Class II 2007/01/17

SA070129 Z-0482-2007 Class II 2007/01/17

SA070130 Z-0486-2007 Class II 2007/01/17

SA070131 Stryker - Simplex P with Tobramycin Anitibiotic PMMA Bone Cement Z-0467-2007 Class II 2007/01/17

SA070132 Varian Medical Systems GammaMed 12i and 12t radionuclide applicator systems Z-0486-2007 to Z-0487-2007 Class II 2007/01/17

SA070133 Z-0483-2007 to Z-0484-2007 Class II 2007/01/17

SA070134 Medtronic International, Ltd. N/A N/A 2007/01/22

SA070135 Toshiba - Xario Main Unit (Model # SSA-660A) 32878 and 33122 Type II 2007/01/22

SA070136 Toshiba - Digital Fluorography System (Model or Catalog # DFP-8000D) 33123 Type II 2007/01/22

SA070137 Toshiba - Aquilion m/s (Model or Catalog # TSX-101A/DC and TSX-101A/8) 32870 Type II 2007/01/22

SA070138 Toshiba - X-Rays High Voltage Generator 33118 Type II 2007/01/22

SA070139 32452 Type II 2007/01/22

SA070140 32607 Type II 2007/01/22

SA070141 Philips Medical System- Allura XPER FD10 and Allura XPER FD20/10 System, Main Unit 33501 Type II 2007/01/22

SA070142 Cordis Prowler Infusion Catheter 32189 Type II 2007/01/22SA070143 Baylis Medical Company, Inc. - Baylis RF Cannula 33251 Type II 2007/01/22

SA070144 Draeger Medical - Medical Air Compressor (Model or Catalog#8413419) 33587 Type II 2007/01/22

SA070145 Alsius Corp. - Cool Line Catheter Model CL-2295AE 33400 Type II 2007/01/22

Integra LifeSciences BOLD/INI-CLIP 2.2mm Drill Bit with AO Attachment. Model/Catalog No. 159004ND FDA

MHRA

MHRA

Select lots of O2Optix (lotrafilcon B) Soft Contact Lenses. The lots affected in this recall are all lots numbers starting with 6644001 to 6721262 with expiration dates starting from 2011/09 to 2011/11, and lot numbers 6626127, 6636101, 6637017, 6637019, 6637103, 6640120, 6640124, 6642109, 6642119, and 6643080, all with expiration dating of 2011/08.

Health Canada

FDA

FDA

FDA

Arjo - BHM Reacher for Portable Ceiling Lifts (Model: Part #700.08310-24' and Part #700.08320-36') FDA

Ossur - Re-Flex VSP and Low Profile Re-Flex VSP external prosthetic foot modules (Model no.: RFXS0002, RFXS0003, RFLS0006 and RFL50007 FDA

FDA

FDA

Baxter Colleague Single and Triple Channel Volumetric Infusion Pumps (Product codes: 2M8151, 2M8151R, 2M8161, 2M8161R, 2M8153, 2M8153R, 2M8163, 2M8163R) FDA

Medtronic - Voluntary Field Corrective Action of Reliant Stent Graft Balloon Catheter and Talent Coiltrac AAA Stent Graft Delivery System with Balloon.

Health Canada

Health Canada

Health Canada

Health Canada

Inverness Medical Professional Diagnostics - Clearview HCG Combo (Model or Catalog # 6026KCV) Health Canada

Inverness Medical Professional Diagnostics - Clearview HCG Combo (Model or Catalog # 6026KCV) Health Canada

Health Canada


Health Canada

Health Canada













http://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/list/rec-ret_md-im_date_jan-march_2007_e.html#top












SA070146 32922 Type II 2007/01/22

SA070147 GE Healthcare - Advantx LCN, Advantx LCLP and Innova 4100 33046 Type II 2007/01/22

SA070148 33058 Type I 2007/01/22

SA070149 33211 Type I 2007/01/22

SA070150 GE Healthcare -Apex Pro/ApexPro CH Telemetry System 2006/012/021/601/481 Field Safety Corrective Action 2007/01/22

SA070151 Interventional Technologies Europe Ltd. - 1 cm Peripheral Cutting Balloon 33497 Type II 2007/01/22


SA070153 Beckman Coulter - Access Immunoassay System CEA (Part no 33200) (Lot no.: ALL) 2006/004/027/121/008 Field Safety Corrective Action 2007/01/25

SA070154 Varian Medical - On Board Imager CBCT 2007/001/008/081/007 Field Safety Corrective Action 2007/01/25

SA070155 Z-0351-2007 to Z-0353-2007 Class II 2007/01/25

SA070156 Abbott Spine TraXis Fixed Trail and TraXis Fixed Rasp Z-0354-2007 to Z-0355-2007 Class II 2007/01/25

SA070157 Embeem Inc - HiZel, Trayless-sterile hydrogel wound dressing Z-0455-2007 Class II 2007/01/25

SA070158 Z-0319-2007 to Z-0321-2007 Class II 2007/01/25

SA070159 Z-0357-2007 Class II 2007/01/25

SA070160 Boston Scientific - HTA System Boston Scientific (HK) Ltd N/A Firm Initiated Field Action 2007/01/26



SA070163 Hemo Cue Ltd - HemoCue Glucose 201 and HemoCue Glucose 201RT instruments 2007/001/015/081/014 Field Safety Corrective Action 2007/01/30

SA070164 Siemens Diagnostics - IMMULITE 2000/2005 Chartable Report Used with SMS 2007/001/023/601/530 Field Safety Corrective Action 2007/01/31

Roche Diagnostics GMBH - Tina-Quant Gen 2 Albumin (ALBT2) R2 and Immunoglobulin G (IGGT) Assay Health Canada

Health Canada

I-Flow Corp. - ON-Q Painbuster, 100ml x 2ml/hr (Model or Catalog#PM012 )(Lot or Serial # 662449, 662742) Health Canada

Airox Legendair Ventilator (Lot or Serial# All Airox Legendair Ventilator LE030007, EXPECT LE020007, LE021009) Health Canada

MHRA

Health Canada

BOC Ltd - AZ size aluminium medical oxygen cylinders fitted with a key operated pin index valve for use in MRI units MHRA

MHRA

MHRA

Bayer Healthcare ADVIA 1650, 1200 and 2400 Chemistry Systems, Automated Clinical Chemistry Analyzer - human serum, plasma and urine tests FDA

FDA

FDA

Rymed Technologies, Inc. - RYM-5000 & RYM-5001 InVision-Plus Neutral Displacement and RYM-5000 InVision-Plus NEUTRAL I.V. Connector FDA

Continental Medical Labs, Inc. -Fibrin Analysis Catheter Testing System includes the component BD Vacutainer Luer-Lok Access Device (Catalog#364902) FDA

Draeger Medical - Neonatal radiant warmer: Draeger Resuscitaire model RW82VHA-1C with variable height adjustment MHRA

Unomedical Ltd - Cord Clamps: Cutter-umbilical cord clamp clipper (lot#102042/118351/121457/134481/136591/142538/146675/151168/155746) MHRA

MHRA

MHRA





















Local Agent


N/A N/A

N/A N/A


N/A N/A

N/A N/A






Terumo China (H.K.) Ltd. 2866 0811Philips Electronics Hong Kong Ltd. 2876 7525


N/A N/A


Smith & Nephew Healthcare Ltd.

2645 8703






N/A N/A

N/A N/A

N/A N/A

CIBA Vision (Hong Kong) Ltd. 2814 2121

STRYKER CHINA LTD 2518 6988

N/A N/A

Viasys Healthcare Hong Kong Ltd


Socofar Ltd 2861 3261

STRYKER CHINA LTD 2518 6988

N/A N/A







Nordep Healthtech 2881 7871

Nordep Healthtech 2881 7871


Johnson & Johnson Medical Hong Kong 2738 2818JOINHANDS TECH LTD 2635 3455


N/A N/A




N/A N/A

N/A N/A


N/A N/A

2372 2288





N/A N/A

N/A N/A

N/A N/A


N/A N/A

N/A N/A



BOC Gases, Hong Kong Oxygen & Acetylene Co Ltd (HKO)

Medical Device Control Office 251 Department of HealthThe Government of the HKSAR



SA061201 Becton Dickinson Asia Ltd. Firm Initiated Field Action 2006/12/04

SA061202 Becton Dickinson Asia Ltd. Firm Initiated Field Action 2006/12/04

SA061203 Baxter Health Flo-Gard 6200, 6201, 6300 & 6301 2006/011/030/291/010 FSCA 2006/12/04

SA061204 Depuy Int. (J&J) Preservation Uni-Compartmental Knee size 3 Fixed - bearing Tibial Tray 2006/011/022/081/001 FSCA 2006/12/04

SA061205 Boston Scientific iLab Ultrasound Imaging System, Installed Models iLab120INS and iLab240INS Boston Scientific H. K. Ltd. Firm Initiated Field Action 2006/12/06

SA061206 Z-0212-2007 to Z-0214-2007 Class II 2006/12/06

SA061207 Nihon Kohden Electric Stimulator, Model number: MS-210BK, Any serial numbers up to 02160 Z-0218-2007 Class II 2006/12/06

SA061208 Z-0221-2007 Class II 2006/12/06

SA061209 Z-0222-2007 Class II 2006/12/06

SA061210 Z-0223-2007 & Z-0224-2007 Class II 2006/12/06

SA061211 Dentsply Friadent XiVE S plus Screw Implant D3.0/L11, D3.0/L13 and D3.0/L15 dental implants Z-0230-2007 to Z-0232-2007 Class II 2006/12/06

SA061212 Cory Brothers Ltd. MPC SCT/50/6 Suctioni Tubing MDA/2006/067 Action 2006/12/06

SA061213 2006/011/030/601/437 FSCA 2006/12/06

SA061214 TomoTherapy Incorporated HI-ART System H-0000, H-0000-0001 2006/011/015/291/006 FSCA 2006/12/06SA061215 Kavo Dental Quattrocare spray can 2006/012/007/081/004 FSCA 2006/12/08

SA061216 Bard Ltd. Peripheral Saxx-Stent and Saxx Premounted Peripheral Stent Implantation System 2006/012/005/601/444 FSCA 2006/12/08

SA061217 Recall # 32712 Type II 2006/12/11

SA061218 Toshiba Medical Systems Aquilion CT Scanner, Model or Catalog # TSX-101A Recall # 31601 Type II 2006/12/11

SA061219 Philips Brilliance CT Big Bore System, Lot or Serial # 7062 and 7017 Recall # 32814 Type II 2006/12/11

SA061220 Conmed Soft Tip Frazier, Frazier Surgical Suction Instrument and Poole Suction Instrument Recall # 32787 Type II 2006/12/11

SA061221 Philips Ultrasound IE33 Diagnostic Ultrasound Transducer, Identifier S12-4 Recall # 32826 Type II 2006/12/11

SA061222 Philips Medical Systems Gemini GXL 6/10/16 Slice Pet/CT System, lot or serial # 882410 Recall # 32827 Type II 2006/12/11

SA061223 Medi-Inn Swabette, model or catalog # MIS300 and MIS401 Recall # 32662 Type II 2006/12/11

SA061224 Recall # 32817 Firm Initiated/Type III 2006/12/11

SA061225 Unomedical A/S Cord Clamp Clipper, Serial # M3186023572, Lot # 125900 Recall # 32928 Type II 2006/12/11

SA061226 Recall # 30550 Type II 2006/12/11

SA061227 Recall # 32953 Type II 2006/12/11

SA061228 Medtronic Precision Plus Transurethral Needle Ablation (TUNA) therapy system, model 7900 Medtronic International, Ltd. Firm Initiated Field Action 2006/12/11

SA061229 Abbott Diagnostics Architect LH Reagent 2006/012/007/601/454 FSCA 2006/12/11SA061230 Accumetrics Inc. Verify Now P2Y12 Assay Device Kit, Part No. 85054 Z-0228-2007 Class II 2006/12/13SA061231 Teleflex Medical Neoprene Pecan Shaped Breathing Bag Z-0244-2007 Class II 2006/12/13

SA061232 Dade Behring Brand MicroScan Prompt Inoculation System-D; Catalog #B1026-10D Z-0247-2007 Class II 2006/12/13

SA061233 Arjo Inc. Sling Rope/Connector Asembly Kits Z-0248-2007 / Z-0249-2007 Class II 2006/12/13

SA061234 Boston Scientific 1cm peripheral cutting balloon microsurgical dilatation devices Boston Scientific H. K. Ltd. Firm Initiated Field Action 2006/12/13

SA061235 Fisher and Paykel Healthcare Ltd (NZ) Acclaim HC401 Nasal Mask 2006/011/023/081/004 FSCA 2006/12/13

SA061236 Fisher and Paykel Healthcare Ltd (NZ) All Single Use Heated Breathing Circuits 2006/012/013/291/005 FSCA 2006/12/13

SA061237 Arcomed Administration Set-3101-LPPJ 2006/012/012/601/458 FSCA 2006/12/14SA061238 Boston Scientific Hemashield vascular grafts and fabrics Boston Scientific H. K. Ltd. Firm Initiated Field Action 2006/12/15

SA061239 Boston Scientific Katzen infusion wires Boston Scientific H. K. Ltd. Firm Initiated Field Action 2006/12/15


BD Pharmingen No Azide/Low Endotoxin Mouse Anti-Human CD16 Monoclonal Antibody, Clone 3G8, Cat. No. 555403, lot # 43033BD Pharmingen PE-Conjugated Mouse Anti-Human Fetal Hemoglobin Monoclonal Antibody, Clone 2D12, Cat. No. 551797, lot # 38377

MHRA

MHRA

Lone Star Medical Products 1100 Series Aluminum Retractor Rings, Models #1104, 1107 and 1110 FDA

FDA

Computerized Medical Systems AccuSeed DS Digital Stepper, an accessory to a prostate radiation treatment planning system, Model #DS300 FDA

Inverness Medical Professional Diagnostics NOW Legionella Urinary Antigen Test. 22 test kit, Product Code: 852-00, Lot Number: 024448 FDA

Data Innovations Roche Modular Drive (rchmdlri) and Roche Cobas driver (rchcob6i) analytical laboratory data interface, various software versions FDA

FDA

MHRAAbbott Molecular Inc. RealTime CT/NG assay and RealTime CT assay List Number 2G28 and 1L31 MHRA

MHRAMHRA

MHRA

Innovatek Medical Quickstick HCG Pregnancy Test Kit, Model or Catalog # 4220-4K, Lot or Serial # 5-09076 Health Canada

Health Canada

Health Canada

Health Canada

Health Canada

Health Canada

Health CanadaLifeScan OneTouch Ultrasmart Blood Glucose Meter, model or catalog # 020-720 and 020-721 with serial numbers starting with TC, TD, TF or TG LifeScan Ltd.

Health CanadaToshiba Medical Systems Digital Fluorography System, Model or Catalog # DFP-8000D and DFP-8000D/FPD Health Canada

Bio-Rad Laboratories Diagnostics D-10 Haemoglobin Testing System - Dual Program, model or catalog # 220-0201 Health Canada

MHRAFDAFDA

FDA

FDA

MHRA

MHRA

MHRA





















http://www.lifescan.com/company/about/press/ultrasmart1106/













SA061240 MDA/2006/071 Action 2006/12/18

SA061241 Lombard Medical - Bifurcated Endovascular Graft Aorfix II 2006/012/014/081/002 FSCA 2006/12/15SA061242 Inditherm Heating Mattress 2006/011/024/401/010 FSCA 2006/12/18

SA061243 Boston Scientific Mach 1 guide catheters Boston Scientific H. K. Ltd. Firm Initiated Field Action 2006/12/19

SA061244 Medtronic Rocker Reducer instruments Medtronic International, Ltd. Firm Initiated Field Action 2006/12/19

SA061245 Biosense Webster Europe Preface Guiding Sheath 2006/011/023/291/013 FSCA 2006/12/18

SA061246 Guidant Ltd. Acrobat Vacuum Stabilizer System 2006/012/007/081/002 FSCA 2006/12/18

SA061247 Femcare-Nikomed Ltd. Femcare Camera Sleeve 2006/012/018/291/025 FSCA 2006/12/19SA061248 Medtronic LIFEPAK 20 Defibrillator/Monitors Medtronic International, Ltd. Firm Initiated Field Action 2006/12/20

SA061249 2006/002/015/291/004 FSCA 2006/12/20

SA061250 LifeScan One Touch Ultra/Basic/Profile Blood Glucose Test Strips Z-0206-2007 / Z-0207-2007 Class I 2006/12/20

SA061251 AMO Tecnis Acrylic Model ZA9003 Intraocular Lenses Z-0148-2007 Class II 2006/12/20

SA061252 Terumo Cardiovascular Systems Terumo Perfusion System Z-0233-2007 to Z-0242-2007 Class II 2006/12/20

SA061253 BD Vacutainer Luer-Lok Access Device Holder with Pre-Attached Multiple Sample Adapter Sterile Z-0253-2007 Class II 2006/12/20

SA061254 AMO PhacoFlex II Model SI40NB Intraocular Lenses Z-0267-2007 Class II 2006/12/20

SA061255 Medline Industries Medline Premium Wet Shin Prep Tray Z-0268-2007 Class II 2006/12/20

SA061256 Gambro Lundia AB (Monitor Division) CWP100 2006/008/017/081/001 FSCA 2006/12/20

SA061257 Biodiagnostics Ltd. Crithidia Luciliae Slides - Catalogue no. L058 / L108 2006/012/004/601/443 FSCA 2006/12/21

SA061258 2006/011/024/081/004 FSCA 2006/12/21

SA061259 Invacare Spectra Plus Powered Wheelchair 2004/011/004/151/010 FSCA 2006/12/21

SA061260 Boston Scientific Wallstent endoscopic biliary endoprosthesis with Unistep Plus delivery system Boston Scientific H. K. Ltd. Firm Initiated Field Action 2006/12/22

SA061261 B Braun Aesculap Metha Modular short Stem Prosthesis 2006/011/023/081/010 FSCA 2006/12/21SA061262 BD Mini Blade Becton Dickinson Asia Ltd. 2006/12/28

SA061263 LifeScan One Touch Ultra/Basic/Profile Blood Glucose Test Strips Z-0261-2007 & Z-0262-2007 Class I 2006/12/27

SA061264 LifeScan One Touch Ultra/Basic/Profile Blood Glucose Test Strips Z-0263-2007 Class I 2006/12/27

SA061265 Medrad Invasive Blood Pressure Interface Cables (Part #3006314, 3008772 & 3010478) Z-0258-2007 & Z0259-2007 Class II 2006/12/27

SA061266 Z-0269-2007 Class II 2006/12/27

SA061267 Arrow Implantable Vascular Access System - Infusion Ports with Silicone Rubber Catheter Z-0270-2007 to Z-0287-2007 Class II 2006/12/27

SA061268 Maillinckrodt OptiVantage DH Power Injection System Z-0288-2007 Class II 2006/12/27

SA061269 Z-0302-2007 Class II 2006/12/27

SA061270 Z-0291-2007 Class II 2006/12/27

SA061271 Terumo Advanced Perfusion System 1 Electonic Oxygen Blender/Analyzerl Catalog No. 801188 Z-0294-2007 Class II 2006/12/27

SA061272 Maquet Critical Care AB HL30 Perfusion System Recall # 33015 Type II 2006/12/27SA061273 Maquet Critical Care AB Jostra Heater-Cooler Unit 30 System Recall # 33014 Type II 2006/12/27SA061274 Elekta Desktop Pro 6.0/6.1 Recall # 32786 Type II 2006/12/27

SA061275 Recall # 33044 Type II 2006/12/27

SA061276 Guidant ACS Rotating Hemostatic Valve Recall # 33048 Type II 2006/12/27

SA061277 GE OEC Medical System, DBA GE Healthcare OEC 9900 Recall # 33053 Type III 2006/12/27

SA061278 Siemens Medical Solutions Linear Accelerators Recall # 33065 Type III 2006/12/27

SA061279 Siemens AG Lithoskop Recall # 33214 Type III 2006/12/27SA061280 Bausch & Lomb 20 Gauge High Speed Electric Vitrectomy Cutters 2006/012/015/081/007 FSCA 2006/12/28SA061281 SuperDimension Bronchus System 2006/012/008/081/012 FSCA 2006/12/28

William Cook Europe Flexor Check-Flo Micropuncture Radial Artery Access Introducer Sets with AQ Hydrophilic Coating MHRA

MHRAMHRA

MHRA

MHRA

MHRA

Smiths Medical International CADD-Legacy PLUS and CADD-Legacy 2 Ambulatory Infusion Pumps -21-6400 & 21-6500 MHRA

FDA

FDA

FDA

FDA

FDA

FDA

MHRA

MHRARoche Diagnostics Cobas Taqman CT test, Amplicor Chlamydia Trachomatis Detection Kit, Amplicor Chlamydia MHRA

MHRA

MHRA

FDA

FDA

FDA

Guidant Contak REnewal 3 RF, 3 RF HE, 4 RF & 4 RF HE cardiac resynchronization therapy defibrillator FDA

FDA

FDADraeger Medical Infinity Docking Station (IDS) Delta and Kappa Patient Monitors. Model Nos. 4715319, 5206110 and 7489375 FDA

Datex Ohmeda Compact Absorber, Disposable REF 427002100, white to violet and REF 427002000 FDA

FDA


Bio-Rad Laboratories Diagnostics Group Liquichek Cardiac Markers Control LT, Model 645, 645X, 646, 647, 648, 649, 649X Health Canada

Health Canada

Health Canada

Health Canada

Health CanadaMHRAMHRA








































Local Agent Remarks

Becton Dickinson Asia Ltd. 2575 8668

Becton Dickinson Asia Ltd. 2575 8668 The local agent informed all affected users.

Baxter Healthcare Ltd. 2807 8556 The local agent informed all affected users.


Boston Scientific H. K. Ltd. 2960 7117

Data Innovations Asia 2398 3182


Interdental Ltd. 2541 1096 The local agent informed all affected users.



Medisource Supply (Asia) Co. Ltd. 2145 4442






Medtronic International, Ltd. 2919 1362 The local agent informed all affected users.


Dade Behring Hong Kong Ltd 2803 0118

Arjo Far East Limited 2508 9553

Boston Scientific H. K. Ltd. 2960 7117 The local agent informed all affected users.






The local agent informed that no affected units had been distributed in Hong Kong.



The local agent informed that no affected units had been distributed in Hong Kong.The local agent informed that no affected units had been distributed in Hong Kong.








Guidant Hong Kong Ltd. 2593 2235

Medtronic International, Ltd. 2919 1362 The local agent informed all affected users.

Smiths Medical (S.E. Asia) Ltd. 2317 0988 The local agent informed all affected users.


AMO Asia Ltd. 2401 5861

Terumo China (H.K.) Ltd. 2866 0811 The local agent informed all affected users.

Becton Dickinson Asia Ltd. 2575 8668

AMO Asia Ltd. 2401 5861



Direct Health Ltd. 2528 1109


B. Braun Medical (Hong Kong) Ltd. 2277 6125Becton Dickinson Asia Ltd. 2575 8668 The local agent informed all affected users.

Johnson & Johnson Medical Hong Kong 2738 2818 The local agent informed all affected users.

Johnson & Johnson Medical Hong Kong 2738 2818 The local agent informed all affected users.

Ultronics Enterprise Ltd. 2764 5208


Draeger Medical Hong Kong Ltd. 2877 3077 The local agent informed all affected users.



Maquet Hong Kong Limited 2393 9511Maquet Hong Kong Limited 2393 9511


Guidant Hong Kong Ltd. 2593 2235



Siemens Ltd. 2870 7533Bausch & Lomb (Hong Kong) Ltd. 2213 3179











Monthly Summary of Medical Device Safety Alerts - November 2006*Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, CanadaMDCO Ref. No. Description of Product Source of Information* Reference No. by Source Alert Type by Source Local Agent

SA060332 Z-0051-2007 Class II Recall 2006/11/01 Tyco Healthcare (HKSAR) Limited

SA060333 GE ApexPro FH Telemetry System, Software versions v3.8 and earlier Z-0054-2007 Class II Recall 2006/11/01 GE Medical Systems Hong Kong Ltd.

SA060334 Depuy PFC Oval Dome Patella, Part Number 960100, Lot: 2203528 Z-0057-2007 Class II Recall 2006/11/01 Johnson & Johnson Medical Hong Kong

SA060335 Cardinal Health Cardiovascular Split Drape II, various models and lot numbers Z-0058-2007 to Z-0062-2007 Class II Recall 2006/11/01 N/A

SA060336 Z-0069-2007 Class II Recall 2006/11/01 Siemens Ltd.

SA060337 Z-0070-2007 to Z-0072-2007 Class II Recall 2006/11/01 Siemens Ltd.

SA060338 Cook Zilver 635 Biliary Stent, Catalog # ZIB6-80-4.0-40, lot 1722922 Z-0080-2007 Class II Recall 2006/11/01

SA060339 Z-0115-2007 Class II Recall 2006/11/01 N/A

SA060340 Siemens MODULARIS Uro endourology tables 2006/010/010/291/005 Field Safety Corrective Action 2006/11/01 Siemens Ltd.

SA060341 Ferno Falcon Six stretcher trolleys 2005/008/001/401/006 Field Safety Corrective Action 2006/11/01 N/A

SA060342 Boston Scientific Mach 1 Peripheral Guide Catheter, lot # 575765 Boston Scientific H. K. Ltd. N/A Urgent Medical Device Recall 2006/11/03 Boston Scientific H. K. Ltd.

SA060343 Welch Allyn Propaq LT patient monitors 2006/011/001/081/001 Field Safety Corrective Action 2006/11/06 N/A

SA060344 Abbott CELL-DYN 22 calibrators and controls 2006/011/003/601/388 Field Safety Corrective Action 2006/11/08 Abbott Laboratories Ltd.

SA060345 Ansell Micro-Touch Nitrile examination gloves 2006/010/031/081/002 Field Safety Corrective Action 2006/11/08 N/A


SA060347 Venoscope Neonatal Transilluminator, Model NT01 Z-0116-2007 Class II Recall 2006/11/08 N/A

SA060327 Respironics, Inc. N/A Urgent Medical Device Recall 2006/11/09 Celki Medical Company

SA060348 BD MultiVisc viscoadaptive solutions (catalog number 581745) 2006/011/001/081/010 Field Safety Corrective Action 2006/11/09 Becton Dickinson Asia Ltd.

SA060349 Getinge steam sterilizers, various models 2006/009/004/081/008 Field Safety Corrective Action 2006/11/09 N/A

SA060350 N/A Firm Press Release 2006/11/09 N/A

SA060351 Toshiba Medical Systems Aquilion and Aquilion CFX Edition 32674 Type II Recall 2006/11/13 Sanko Medical Systems (H.K.) Ltd.

SA060352 Toshiba Medical Systems Aquillion 16-Slice System 32639 Type II Recall 2006/11/13 Sanko Medical Systems (H.K.) Ltd.

SA060353 Arjo Minstrel Lift with Scale 32598 Type II Recall 2006/11/13 Arjo Far East Limited

SA060354 32528 Type II Recall 2006/11/13 Agfa Hong Kong Ltd.

SA060355 Implant Innovations ITHA52 Certain EP Healing Abutment, Lot or Serial # 560988 32627 Type II Recall 2006/11/13 N/A

SA060328 Calley & Currier Laminated Wooden Crutches, various models and catalog numbers 32593 Type II Recall 2006/11/13 N/A

SA060356 32498 Type II Recall 2006/11/13 Elekta Ltd.


Kendall Monoject Syringe with Hypodermic Needle, 3cc syringe with 27 ga A-Bevel Needle (3cc-27x1-1/4 A) Product # 888153744 FDA

FDA

FDA

FDA

Siemens Medical Solutions Sienet Cosmos V15C, model number 10018969, Serial numbers 1001, 1010, 1011, 1028, and 1029 FDA

Siemens Medical Solutions Syngo Imaging, Sienet Sky and Sienet Magic View 300 picture archiving and communications systems FDA

FDA (1) Cook Asia (Hong Kong) Ltd.; (2) A.R. Burkhill & Sons (Hong Kong) Ltd.

Radiometer America Radiance Data Management System, Software Version 2.60, modification for the ABL800 Flex Blood Gas Analyzer, Catalog Numbers: 914-418 and 914-426

FDA

MHRA

MHRA

MHRA

MHRA

MHRA

Hardy Media HardyCHROM 0157, Catalogue Number G305, Lot numbers 06192 and 06235 FDA

FDA

Respironics REMstar Heated humidifier, model nos. 1007861, R1007861, JP1007861 and 1005732, Serial no: H045582 to H239662 (inclusive)

MHRA

MHRA

Endologix Visiflex bifurcated Delivery Catheters, 155mm, used for the Powerlink System (models 25-16-155BL and 28-16-155BL) FDA

Health Canada

Health Canada

Health Canada

AGFA CR NX Modality Workstation, model or catalog # ES885, versions NX 1.0.2402 and NX 1.0.2405 Health Canada

Health Canada

Health Canada

Elekta Instruments AB Leksell Gamma Knife C Version 1.2/4C, Lot or Serial # 4310 and 4336 Health Canada


















http://www.fda.gov/oc/po/firmrecalls/endologix11_06.html









SA060357 Draeger Medical Narkomed 6000 Series Anesthesia Machine 32451 Type II Recall 2006/11/13 Draeger Medical Hong Kong Ltd.

SA060358 Toshiba Medical Systems Opart MRI System 32523 Type II Recall 2006/11/13 Sanko Medical Systems (H.K.) Ltd.

SA060359 Immucor Panocell-16, 16 x 3ml, model or catalog # 0002332, lot or serial # 35411 32531 Type II Recall 2006/11/13 Uninet Technology Ltd.

SA060360 Smith & Nephew Profix Hall 3/4 Fanned Sawblade, model or catalog # 71512903 32280 Type II Recall 2006/11/13 Smith & Nephew Healthcare Ltd.

SA060361 Beckman Coulter EPOCS SL Flow Cytometers with EXPO 32 ADC Software 2006/011/010/291/002 Field Safety Corrective Action 2006/11/13 Beckman Coulter Hong Kong Ltd.

SA060362 2006/011/009/081/009 Field Safety Corrective Action 2006/11/14 Smiths Medical (S.E. Asia) Ltd.

SA060329 Z-0018-2007 to Z-0020-2007 Class II Recall 2006/11/15 Ciba Vision Hong Kong Ltd.

SA060363 Z-0120-2007 & Z-0121-2007 Class II Recall 2006/11/15 N/A


SA060365 DePuy Spine Bremer Halo System, various models Z-0130-2007 to Z-0144-2007 Class II Recall 2006/11/15 Johnson & Johnson Medical Hong Kong

SA060366 Z-0151-2007 Class II Recall 2006/11/15 HealthCare Diagnostics Ltd.





SA060371 Maquet Jostra HL-20 Heart Lung Machine - guiding pins Z-0159-2007 Class II Recall 2006/11/15 Maquet Hong Kong Limited

SA060372 Cook Endoscopy Fusion OMNI ERCP Catheter, Lot number W2243511 Z-0160-2007 Class II Recall 2006/11/15


SA060330 BD Insulin Pen Needles, 31G 5mm, Catalog No. 320129 N/A Voluntary Recall 2006/11/15 Becton Dickinson Asia Ltd.

SA060374 Beckman Coulter Access Immunoassay Systems Thyroglobulin Antibody 2006/011/014/291/014 Field Safety Corrective Action 2006/11/15 Beckman Coulter Hong Kong Ltd.

SA060375 Draeger Medical Infant Warmer - RW82VHA-1C 2005/005/025/401/001 Field Safety Corrective Action 2006/11/15 Draeger Medical Hong Kong Ltd.

SA060376 Novagen Ltd 2mm Angled Suction Tip 2006/011/010/401/006 Field Safety Corrective Action 2006/11/15 Onwon Trading Limited

SA060377 Molnlycke Health Card Camera Drape - ProcedurePak Trays 2006/011/013/081/007 Field Safety Corrective Action 2006/11/16 N/A

SA060378 Medtronic International, Ltd. N/A 2006/11/17 Medtronic International, Ltd.

SA060379 Ferno Restraining straps/harness-Pedi-Mate 678 2004/012/001/061/029 Field Safety Corrective Action 2006/11/17 N/A

SA060380 Owen Mumford Unistik 3 Neonatal & Laboratory/Confort/Normal 2006/011/013/291/002 Field Safety Corrective Action 2006/11/20 N/A

SA060381 Full Spectrum Lighting T/a S.A.D. Lightbox Company Machine Therapy-LPD24 2006/010/013/601/34 Field Safety Corrective Action 2006/11/20 N/A

SA060382 Bard Access Systems HemoGlide Catheter Kits 2006/008/031/291/002 Field Safety Corrective Action 2006/11/20 N/A

SA060383 Tyco Healthcare OptiVantage DH Contrast Media Injection System 2006/011/014/081/008 Field Safety Corrective Action 2006/11/20 Tyco Healthcare (HKSAR) Limited

Health Canada

Health Canada

Health Canada

Health Canada

MHRA

Smiths Medical Level 1 D-60HK and DI-60HL Normothermic I.V. Fluid Administration Sets MHRA

Ciba Vision CSI Daily Wear, CSI Flexible Wear and CSI Toric soft (hydrophilic) contact lenses FDA

Enpath Medical pacemaker lead adapter and Angel Medical Systems Lead Adaptor system FDA

Hydrocision SpineJet XL MIS 20 and SpineJet XL MIS 30 degree Handpieces, Catalog Numbers 58662 and 58663 FDA

FDA

Ortho-Clinical Diagnostics VITROS Chemistry Products GLU DT Slides GEN 56, REF (Catalog #) 153 2316, 25 slides per box FDA

Hitachi Medical Systems Echelon Magnetic Resonance Imaging System, Serial Number: V001 FDA

Precision Medical Easy Mate Portable Liquid Oxygen System (container), PM22010 Series, Model number 2201, serial numbers P002892 through P005116 FDA

Access Point Medical Heavy Duty Rollators (rolling walker), Product Codes: RL12010HD and RL12011 FDA

Lumiport DermaStyle Chroma 2-blue and red light device indicated to be used in treating skin blemishes, portable home therapy FDA

FDA

FDA (1) Cook Asia (Hong Kong) Ltd.; (2) A.R. Burkhill & Sons (Hong Kong) Ltd.

USA Instruments 1.5T HD Head Neck Spine Array (Model 2416329, for GE 1.5T Excite MR System) and 3.0T HD Head Neck Spine Array (Model 2415545, for GE 3.0T Excite MR System)

FDA

Becton Dickinson and Company (Japan)

MHRA

MHRA

MHRA

MHRA

Medtronic SynchroMed® and IsoMed® Implantable Pain Infusion Pumps, various models

Important Patient Safety Management Information

MHRA

MHRA

MHRA

MHRA

MHRA



















http://www.bdj.co.jp/press/20061115.html











SA060384 Boston Scientific H. K. Ltd. N/A 2006/11/21 Boston Scientific H. K. Ltd.

SA060385 Boston Scientific H. K. Ltd. N/A Urgent Medical Device Recall 2006/11/21 Boston Scientific H. K. Ltd.

SA060331 AMO Asia Limited N/A Voluntary Recall 2006/11/22 AMO Asia Limited

SA060386 2006/009/012/291/010 Field Safety Corrective Action 2006/11/21 Roche Diagnostics (Hong Kong) Limited

SA060387 Philips Allura X-per FD10/10 and FD20/10 X-ray and fluoroscopy systems Z-0165-2007 & Z-0166-2007 Class II Recall 2006/11/22 Philips Electronics Hong Kong Ltd.

SA060388 Z-0167-2007 Class II Recall 2006/11/22 Data Innovations Asia

SA060389 Baxter Meridian hemodialysis instruments, product codes 5M5576 and 5M5576R Z-0169-2007 Class II Recall 2006/11/22 Baxter Healthcare Ltd.

SA060390 Bemis 5 Qt. Wallmount Sharps Container, Model 150, Regular Size Z-0170-2007 Class II Recall 2006/11/22 N/A


SA060392 Z-0183-2007 & Z-0184-2007 Class II Recall 2006/11/22 Philips Electronics Hong Kong Ltd.

SA060393 Z-0185-2007 to Z-0188-2007 Class II Recall 2006/11/22 N/A


SA060395 Z-0190-2007 Class II Recall 2006/11/22 Zimmer PTE Ltd. (Hong Kong branch)


SA060397 Ekos Lysus Transport Stand (infusion stand), part number 4896-003 Z-0195-2007 Class II Recall 2006/11/22 N/A

SA060398 30937 Type II Recall 2006/11/27 N/A


SA060400 Rocket Medical Fetal Blood Sampling Kit 2006/007/005/601/166 Field Safety Corrective Action 2006/11/27 N/A

SA060401 Bard Ltd. Stone Basket - 042310, 042313, 042316, 043310, 043313, 043316 2006/011/024/601/421 Field Safety Corrective Action 2006/11/27 N/A

SA060402 Elekta Instruments AB Leksell Gamma Knife, model or catalog # 912800 32733 Type II Recall 2006/11/27 Elekta Ltd.

SA060403 Rocialle InHealth Sterile Procedure Pack - Basic Pack 2006/011/009/291/005 Field Safety Corrective Action 2006/11/28 N/A

SA060404 Abbott AxSYM Matrix Cells, Product List No: 8A73-02, Lot # 37618Q100 Z-0117-2007 Class II Recall 2006/11/29 Abbott Laboratories Ltd.

SA060405 Plus Orthopedics UC-PLUS Solution Unicondylar Knee Systems Z-0191-2007 & Z-0192-2007 Class II Recall 2006/11/29 N/A




SA060409 Datex-Ohmeda Tec 6 Plus Desflurane Vaporizer, various serial numbers Z-0201-2007 Class II Recall 2006/11/29 Hong Kong Oxygen & Acetylene Co. Ltd.

Boston Scientific System Drape (IVUS motor drive sterile plastic cover), lot numbers M846990, M835770 and M844470

Medical Device Customer Notification

Boston Scientific Jagwire High Performance Guidewire (lot # 8887513) and Jagwire High Performance Extendable Guidewire (lot # 8887514)

Specific Lots of AMO Lens Plus OcuPure Saline, COMPLETE Multi-Purpose Solutions, and COMPLETE MoisturePLUS Multi-Purpose Solutions (Starter Kits)

Roche Diagnostics Acc-chek Multclix, Softclix, Softclix Plus and CoaguChek Softclix single-patient self-testing lancing systems MHRA

FDA

Data Innovations Instrument Manager Version 8:00, 8.01, 8.02, 8.03 or 8.04 with Specimen Management and using Results/Edit/ReleaseScreen (R/E/R) FDA

FDA

FDA

Olsen Medical MIDAS TOUCH Electrosurgical/102 mm (4 inch) Blade Electrodes, Disposable, Sterile Single Use Device, Part #30-0012 and Model #30-0002 FDA

Philips Medical Systems M3001A Multi Measurement Server (MMS) and M1020B Pulse Oximetry Module Philips FAST Sp02 and Pulse Oximetry Nellcor OxiMax Compatible used with the IntelliVue or M3/M4 patient monitor M1002

FDA

Sorenson Medical ambIT Ambulatory Infusion Pump Cassettes, REF numbers 220139, 220140, 220266 and 220267, all serial numbers FDA

Eatonform Doc-U-Dose Prescription Management System, Item 8-PKIT, Carton numbers: 16 through 39 FDA

Zimmer Spine ST360 Distal Thread Reduction Guide Pins, Lot numbers: P031530, P031650, P040389, P040111, P051160, P051161 FDA

Trionix Research Laboratory BIAD Classic 24 (24 inch collimator), Serial numbers B-102 through B-184 FDA

FDA

Balt Extrusion Flow Dependent Micro-Catheter, models MAGIC 1.2FM, MAGIC MP and MAGIC STD Health Canada

Tornier Latitude Elbow Prosthesis Radial Head, models or catalog # DKY056, DKY057, DKY058 and DKY059 Health Canada

MHRA

MHRA

Health Canada

MHRA

FDA

FDA

Exactech Optetrak B-series cemented finned tibial tray, size 2f/2t, catalog # 220-04-02, serial numbers 0886395 - 0886424 FDA

Iris Sample Processing StatSpin Express 3 Centrifuge with RTX8 Rotor Model: M502, Serial numbers: B1562 to B1738 FDA

Dako Colorado Eridan Automated Slide Stainer and Support Cart, REF E300 and E300SC1 FDA

FDA


























SA060410 Access Point Medical Canes, various models Z-0202-2007 to Z-0205-2007 Class II Recall 2006/11/29 N/A

SA060411 Z-0208-2007 Class II Recall 2006/11/29 Medtronic International, Ltd.



SA060414 Z-0220-2007 Class II Recall 2006/11/29 Konica Minolta Business Solutions (HK) Ltd.

SA060415 Vygon Paediatric 96Hr IV Filter 0.22M + extension line 0807.205 2006/011/017/401/001 Field Safety Corrective Action 2006/11/29 N/A

SA060416 Smiths Medical International Monitor Patient-BCI Autocorr 3404 2006/011/022/291/010 Field Safety Corrective Action 2006/11/29 Smiths Medical (S.E. Asia) Ltd.

SA060417 Pegasus Ltd. Altas and Paragon Bed Frames 2006/011/003/261/001 Field Safety Corrective Action 2006/11/29 N/A

SA060418 Bayer HealthCare ADVIA Centaur CP Immunoassay System 2006/011/027/601/428 Field Safety Corrective Action 2006/11/29 Bayer Healthcare Ltd. (Hong Kong)

FDA

Medtronic Vascular Pioneer Catheter (Crosspoint TransAccess Catheter), Model TA-XP-001, all codes FDA

Zimmer NexGen Complete Knee Solution Legacy Knee Tibial Component, Catalog no. 05-5998-038-02, Lot 60472442 FDA

Zimmer Trabecular metal shoulder instrumentation proximal provisional humeral stem, Catalog no. 00-4309-018-10, Lots: 60457716 and 60492624 FDA

Konica Minolta PrintLink III Model - ID/IV, product code no. 0770, 0771 Medical Imaging Communication Device Model IV - product code 5000230 Model ID, product code 5000330

FDA

MHRA

MHRA

MHRA

MHRA











Monthly Summary of Medical Device Safety Alerts - November 2006*Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, Canada

Agent Contact Telephone No. Remarks

2574 3251

2783 1838 The local agent informed that no affected units had been distributed in Hong Kong.


N/A


2870 7533

(1) 2781 0232; (2) 2541 1041 The local agents informed that no affected units had been distributed in Hong Kong.

N/A The manufacturer informed that no affected units had been distributed in Hong Kong.




N/A

2806 4201 The local agent informed all affected users.




2268 9229 With affected units in Hong Kong.


N/A


2384 0688

2384 0688

2508 9553


N/A







2645 8703The local agent informed that no affected units had been distributed in Hong Kong.

2240 6260










N/A


(1) 2781 0232; (2) 2541 1041 The local agent informed that no affected units had been distributed in Hong Kong.


2575 8668

2240 6260

2877 3077

2757 7569

N/A


N/A



N/A

2574 3251

The local agent confirmed having no record of importing the affected devices into Hong Kong.




2401 5811 and 2401 5812 Click on the Press Release by AMO Asia for details:



2398 3182


N/A


2876 7525


N/A



N/A


N/A



2892 4320

N/A

2806 4201



N/A



AMO's Press Release








2317 0988 1 affected unit in Hong Kong.

N/A

2814 4829


Monthly Summary of Medical Device Safety Alerts - October 2006*Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, CanadaMDCO Ref. No. Description of Product Source of Information* Reference No. by Source Alert Type by Source Local Agent

SA060247 Computerized Medical Systems Software Releases 2.1.0 - 4.3.0, all lot numbers 32273 Type II Recall 2006/10/02 N/A

SA060248 Hill-Rom Patient Pendants, model or catalog # P3207A01 & P3207A02 32294 Type II Recall 2006/10/02 Solar Medical Ltd.


SA060250 32333 Type II Recall 2006/10/02 Baxter Healthcare Ltd.


SA060252 Applied Medical Technology Endovive Enteral Feeding Device, specific lots Boston Scientific H. K. Ltd. N/A Medical Device Market Withdrawal 2006/10/03 Boston Scientific H. K. Ltd.

SA060253 MDA/2006/057 Action 2006/10/03 N/A

SA060254 Baxter Healthcare, Administration Set-Continu Flo Solution Sets with Check Valve 2006/009/020/291/016 Field Safety Corrective Action 2006/10/03 Baxter Healthcare Ltd.

SA060255 B. Braun Arterial / Venous Blood Line, 7210697 2006/009/026/291/011 Field Safety Corrective Action 2006/10/03 B. Braun Medical (Hong Kong) Ltd.

SA060256 Terumo Khuri Myocardial PH Monitoring System, Catalog number 7205 Z-1517-06 Class II Recall 2006/10/04 Terumo China (H.K.) Ltd.


SA060258 Z-1525-06 Class II Recall 2006/10/04 Becton Dickinson Asia Ltd.

SA060259 Ogenix EpiFLO SD Clinical Users Guide (CUG), Part #01-100-1000000 Z-1526-06 Class II Recall 2006/10/04 N/A


SA060261 INO Therapeutics INOvent System O Ring Failures 2006/004/003/401/004 Field Safety Corrective Action 2006/10/04 Hong Kong Oxygen & Acetylene Co. Ltd.

SA060262 Codan Great Britain Pump volumetric Argus 708 2006/007/012/291/010 Field Safety Corrective Action 2006/10/04 N/A

SA060263 Abbott Laboratories AsSYM Myoglobin Reagent Kit List Number 7K48-20 2006/009/029/601/319 Field Safety Corrective Action 2006/10/04 Abbott Laboratories Ltd.

SA060264 2006-022 Urgent Medical Device Correction 2006/10/06 Varian Medical Systems Pacific Inc.

SA060265 GE Healthcare Technologies (Prev Datex Ohmeda) Monitor Patient - N-AC 2006/009/027/601/315 Field Safety Corrective Action 2006/10/06 GE Medical Systems Hong Kong Ltd.

SA060266 Becton Dickinson Asia Ltd. N/A Customer Notification 2006/10/09 Becton Dickinson Asia Ltd.

SA060267 Prorhtym Cardiac ablation system - 25mm & 30mm HIFU ablation catherter 2006/007/013/081/002 Field Safety Corrective Action 2006/10/10 N/A

SA060268 Abbott Laboratories CELL-DYN 22 Calibrators-99120-01 2006/010/002/901/325 Field Safety Corrective Action 2006/10/11 Abbott Laboratories Ltd.

SA060269 Cory Bros Ltd, Tubing suction - Ref: CST/50/6 2006/008/015/401/002 Field Safety Corrective Action 2006/10/11 N/A

SA060270 Z-0704-06 Class II Recall 2006/10/11 GE Medical Systems Hong Kong Ltd.

SA060271 Z-1301-06 to Z-1303-06 Class II Recall 2006/10/11 GE Medical Systems Hong Kong Ltd.

SA060272 Smith & Nephew Hip Positioning System with various System Components Z-1514-06 Class II Recall 2006/10/11 Smith & Nephew Healthcare Ltd.

SA060273 GE Precision RX/I System, all units Z-1485-06 Class II Recall 2006/10/11 GE Medical Systems Hong Kong Ltd.

SA060274 Pointe Scientific Alcohol reagent sets and control standards, various models Z-1543-06 to Z-1549-06 Class II Recall 2006/10/11 Evergreen Health Care Ltd.


Health Canada

Health Canada

Radiometer Medical APS CAL 2 Solution, model or catalog # S1730, lot or serial number QR-02 Health Canada

Baxter Healthcare Colleague 3 Volumetric Infusion Pump, models 2M8153, 2M8153R, 2M8163, 2M8163R, DNM8153 & DNM8153R Health Canada

Ondine Biopharma Periowave Disinfection System Footswitch, model or catalog # PW1002 and PW1100, lot or serial number PW-D06-00001 to PW-D06-00400 Health Canada

Huntleigh birthing beds, Models 35000 and 170000; Hoskins Birthcare, Models L10 and L05 MHRA

MHRA

MHRA

FDA

Kerr RempBond Clear Syringes (base and catalyst kit), a temporary dental cement, Part Number 28637 FDA

BD 1mL Safety Glide Allergy and Tuberculin Syringes. Reorder Number 305945 and 305950 FDA

FDA

International Medsurg Connection Allegiance Esmark Bandages, catalog numbers 24593-043A, 24593-044A, 24593-063A and 24593-064A FDA

MHRA

MHRA

MHRA

Varian 4D Integrated Treatment Console treatment control station for radiation therapy linear accelerators


MHRA

BD Pharmingen No Azide/Low Endotoxin Mouse Anti-Human HLA-DR, DP, DQ Monoclonal Antibody, Clone TU39, Cat. No. 555556

MHRA

MHRA

MHRA

GE OEC Medical Systems MiniView 6800 Digital Mobile C-arm fluoroscopic x-ray system FDA

GE OEC Medical Systems 9900 Elite Digital Mobile C-arm X-ray system, 9800 Fluoro C-arm X-ray system and RUS Tool Version Software FDA

FDA

FDA

FDA




























SA060276 Thoratec brand TLC-11 Portable Ventricular Assist Device (VAD) Driver Z-0004-07 Class II Recall 2006/10/11 N/A

SA060277 Stryker Navigation Systems with Dell laptop computer model D800 Z-0005-07 to Z-0008-07 Class II Recall 2006/10/11 Stryker Hong Kong

SA060278 Z-0009-07 to Z-0011-07 Class II Recall 2006/10/11 Smith & Nephew Healthcare Ltd.

SA060279 Actamed Ltd Ranger High Flow Blood/Fluid Warming Sets 2006/004/027/601/094 Field Safety Corrective Action 2006/10/12 N/A

SA060166 Jenx Ltd. Seating support systems for children MDA/2006/059 Immediate Action 2006/10/12 N/A

SA060280 BD Procount Kit, Part No. 340498, Lot No. 51184 and 57281 Becton Dickinson Asia Ltd. N/A Product Field Action Notification 2006/10/13 Becton Dickinson Asia Ltd.

SA060237 N/A Important Information 2006/10/13 St. Jude Medical (Hong Kong) Ltd.

SA060236 P06-167 FDA News 2006/10/13 Johnson & Johnson Medical Hong Kong

SA060281 2006/010/003/081/006 Field Safety Corrective Action 2006/10/16 Beijing Since Medical Scientific Co. Ltd.

SA060282 BD Procount Progenitor Cell Enumeration, Part No. 340498, Lot No. 45602 32353 Type II Recall 2006/10/16 Becton Dickinson Asia Ltd.


SA060284 Teraklin AG Mars Treatment Kit 32120 Type II Recall 2006/10/16 Gambro China Ltd.

SA060285 Biomerieux Slidex Pneumo-Kit, model or catalog # 58821, lot or serial # 50417 32374 Type II Recall 2006/10/16 BioMerieux China Limited

SA060286 Michigan Instruments Thumper Mechanical CPR Device, model or catalog # 1007 32375 Type II Recall 2006/10/16 Beijing Ji Yuan Electronic Co.

SA060287 Randox Laboratories Fructosamine Control Level 1, lot or serial # 239FR 32310 Type II Recall 2006/10/16 N/A

SA060288 Boston Scientific Interlock Detachable Coils For Occlusion, lot number 6628239 Boston Scientific H. K. Ltd. N/A Urgent Medical Device Recall 2006/10/17 Boston Scientific H. K. Ltd.

SA060289 Boston Scientific Renegade 18 Microcatheter, lot number 7513978 Boston Scientific H. K. Ltd. N/A Urgent Medical Device Recall 2006/10/17 Boston Scientific H. K. Ltd.

SA060290 Boston Scientific Stainless Steel Greenfield Vena Cava Filter, lot number 7826572 Boston Scientific H. K. Ltd. N/A Urgent Medical Device Recall 2006/10/17 Boston Scientific H. K. Ltd.

SA060291 Advanced Bionics N/A Important Notification 2006/10/17 Boston Scientific H. K. Ltd.

SA060292 Elekta Ltd. Precise Desktop R4.2 and DesktopPro R5.0 2006/010/013/601/347 Field Safety Corrective Action 2006/10/17 Elekta Ltd.


SA060294 Z-0027-2007 Class II Recall 2006/10/18 3M Hong Kong Ltd.



SA060297 AGFA CR DX-S Image Intensified Fluoroscopic X-ray system Z-0031-2007 Class II Recall 2006/10/18 Agfa Hong Kong Ltd.

SA060298 Z-0035-2007 Class II Recall 2006/10/18 Haemonetics (Hong Kong) Limited

SA060299 Roche Diagnostics CoaguChek PT test strips N/A Press Release 2006/10/19 Roche Diagnostics (Hong Kong) Limited

GE OEC Medical Systems 4 inch Anterior Cervical Post, Part Number: 1006385 or 1006385-NAV, an accessory used with the InstaTrak 3500 plus and 9800 C-Arm Navigation systems

FDA

FDA

FDA

Smith & Nephew Journey Nonporous Fin-Stem Tibial Punch, Genesis II Nonporous Fin-Stem Tibial Punch and Genesis II Oversized Nonporous Fin-Stem Tibial Punch FDA

MHRA

MHRA

St. Jude APS III Model 3500/3510 and Merlin PCS Model 3650 programmers used with certain St. Jude Identity pacemakers (Identity SR Model 5172, Identity DR Model 5370 and Identity XL DR Model 5376)

St. Jude Medical, Inc.

LifeScan OneTouch Basic/Profile (lot # 272894A, 2619932, 2606340) and OneTouch Ultra (lot # 2691191) Blood Glucose Test Strips FDA

AGA Medical Corporation Delivery System Amplatzer TorqVue Delivery and Exchange Systems MHRA

Health Canada

Walter Lorenz Surgical Lactosorb Suspension Screw, model or catalog # 915-2335, lot or serial # 753200 Health Canada

Health Canada

Health Canada

Health Canada

Health Canada

Advanced Bionics Linear Family Leads (product numbers SC-2108, SC-2138, SC-2148 series)

MHRA

Thoratec brand Sealed Arterial Cannula for use with the Thoratec Ventricular Assist Device System FDA

3M Comply 1248 Gas Plasma Chemical Indicator Strips for use in STERRAD 100, STERRAD 100S and STERRAD 50 Sterilization Systems, Lot numbers 2006-12 AA through 2008-06 AB

FDA

Hitachi Medical Systems MRP-7000 and AIRIS Magnetic Resonance Imaging Systems, Software Versions: V7.0A to V7.0J FDA

Arrow Double-Lumen Balloon Wedge Pressure Catheter, for sampling blood for oxygen levels and measuring pressures in the right heart FDA

FDA

Haemonetics SmartSuction Harmony Powered Suction Device, Model number: HAR-E-115-US FDA

FDA







http://phx.corporate-ir.net/phoenix.zhtml?c=73836&p=IROL-SingleRelease_print&t=NewsRelease&id=915999&highlight=
















http://www.fda.gov/oc/po/firmrecalls/roche10_06.html


SA060239 Sunrise Medical Jay J2, Wheelchair back MDA/2006/060 Action 2006/10/19 N/A

SA060240 Z-0022-0007 Class I Recall 2006/10/20 Medtronic International, Ltd.

SA060300 Lenox-Maclaren Bone Fragmenter, Catalog # 9150111, all lots Medtronic International, Ltd. N/A Voluntary Field Corrective Action 2006/10/20 Medtronic International, Ltd.

SA060301 2006/007/027/291/001 Field Safety Corrective Action 2006/10/23 Olympus Hong Kong Ltd

SA060241 LifeScan, Inc, One Touch Basic/Profile and One Touch Ultra Blood Glucose Test Strips P06-174 FDA News 2006/10/23 Johnson & Johnson Medical Hong Kong


SA060303 Z-0034-2007 Class II Recall 2006/10/25 Becton Dickinson Asia Ltd.




SA060306 GE OEC 9900 Elite Fluoroscopy System, Catalog No. 887208 and 887210 Z-0042-2007 Class II Recall 2006/10/25 GE Medical Systems Hong Kong Ltd.

SA060307 Z-0043-2007 Class II Recall 2006/10/25 Johnson & Johnson Medical Hong Kong



SA060310 Draeger Fabius GS Anesthesia Machine, Catalog number 8604699 Z-0048-2007 Class II Recall 2006/10/25 Draeger Medical Hong Kong Ltd.


SA060312 Z-0050-2007 Class II Recall 2006/10/25 Medtronic International, Ltd.

SA060313 AGA Medical AMPLATZER PFO Occluder, Order No. 9-PFO-018 and 9-PFO-025 Z-0052-2007 & Z-0053-2007 Class II Recall 2006/10/25 Beijing Since Medical Scientific Co. Ltd.

SA060314 GE ApexPro CH Telemetry System, Software version 3.8 and earlier Z-0055-2007 Class II Recall 2006/10/25 GE Medical Systems Hong Kong Ltd.

SA060315 Omega truCATH catheters (TCH-10) 2006/010/004/401/021 Field Safety Corrective Action 2006/10/25 N/A

SA060316 Southern Scientific Autotilt ultrasound couches 2006/070/019/601/356 Field Safety Corrective Action 2006/10/25 N/A

SA060317 2006/010/020/081/015 Field Safety Corrective Action 2006/10/25 Siemens Ltd.

SA060327 Respironics, Inc. N/A Urgent Medical Device Recall 2006/10/25 Celki Medical Company

SA060243 BHM Medical Kwiktrak Fix Gate, Model or Catalog # 700.11500 and 700.11505 32430 Type I Recall 2006/10/30 N/A

SA060244 Sunrise Medical Canada 5in Wheels Kits and Guardian Walkers 32469 Type II Recall 2006/10/30 N/A


SA060319 AMD-Ritmed Abdominal Pads, Model or Catalog # A-7059, Lot or Serial # 2095 32484 Type II Recall 2006/10/30 N/A

SA060320 GE Centricity Triwin Laboratory Information System - Microbiology Module, Version 7.4 32311 Type II Recall 2006/10/30 GE Medical Systems Hong Kong Ltd.

SA060321 32286 Type II Recall 2006/10/30 Smith & Nephew Healthcare Ltd.

MHRA

Medtronic SynchroMed EL Programmable Infusion Pumps, Models 8627-10, 8627-18, 8627L-10, 8627L-18 FDA

Olympus Life and Material Science Europa GmbH - CRP Latex C-Reactive Protein (OSR6199) MHRA

FDA

GF Health Products ECAT (Extended Care Air Therapy Systems) 2000 Safe Enclosure Bed FDA

BD Vacutainer Push Button Blood Collection Set with Pre-attached Holder, Catalog numbers 367352 and 368656 FDA

Medline Industries Strider Maxi 3 and Maxi 4 Scooters, red and blue models, all serial numbers FDA

Eagle Parts and Products Models 624EZ and 624Mini Power Wheel Chairs with internally threaded wheel mount motors, Serial numbers 624EZ0010 through 624EZ0513

FDA

GE OEC 9900 Elite Fluoroscopy System with Integrated Navigation, Catalog Numbers 887208 and 887210 FDA

FDA

Bioplate Resorbable Bone Fixation Tack, Catalog Number 89-0120, Item Number SG#-45, Lot number S2964090 FDA

Excelsior Medical 0.9% Sodium Chloride Flush Syringe, 2.5 mL. Product Code: E0100 under Hospira's label, Syrex, Lot: 22-010-9D FDA

Eatonform Doc-U-Dose Prescription Management System, Item #8-PKIT, lots 312733, 312734, 313767 and 313768 FDA

FDA

Del Medical DynaRad Phantom Portable X-Ray System, Phantom model (PH-150-CM & PH-150-G) FDA

Medtronic Sofamor Danek Implant Hollow Reamer, 14 mm, REF 8951405, Lot Numbers CN04J012 and CN 06A003 FDA

FDA

FDA

MHRA

MHRA

Siemens MAGNETOM Trio and MAGNETOM Trio a Tim magnetic resonance imaging systems MHRA

Respironics REMstar Heated humidifier, model nos. 1007861, R1007861, JP1007861 and 1005732, Serial no: H045582 to H239662 (inclusive)

Health Canada

Health Canada

Teleflex Medical Sher-i-Bronch Endobronchial Tube 37Fr, Sheridan Preformed Cuffed Nasal Endo., Sheridan Preformed Cuffed Oral Endo.5mm, Sheridan Preformed Uncuffed Oral Endo. and Sheridan Tracheal Tube Exchanger

Health Canada

Health Canada

Health Canada

Smith & Nephew Legion Offset Coupler Trials, Model or Catalog # 71434301, 71434302, 71434304 and 71434306 Health Canada






























SA060245 LifeScan OneTouch SureStep Test Strips, Lot or serial # 2631383 32428 Type II Recall 2006/10/30 Johnson & Johnson Medical Hong Kong

SA060323 2006/010/025/081/009 Field Safety Corrective Action 2006/10/31 N/A

SA060324 Galls Dyna Med patient transfer sheets 2005/001/010/401/003 Field Safety Corrective Action 2006/10/31 N/A

SA060325 Biomet modular femoral heads 2006/010/024/181/005 Field Safety Corrective Action 2006/10/31 N/A

SA060326 2006/010/026/111/002 Field Safety Corrective Action 2006/10/31 Beckman Coulter Hong Kong Ltd.

SA060246a

N/A Public Annoucement 2006/10/31

N/A

SA060246b N/A

SA060246c N/A

SA060246d Alcon Hong Kong Ltd.

Micrus Endovascular Guidewire Insertion Device, Lot or Serial # F22741, F22743 and F22744 Health Canada

Health Canada

ConMed Detacha Tip Multi-Use Laparoscopic Instruments and Disposable Hand Held Graspers and Dissectors MHRA

MHRA

MHRA

Beckman Coulter FC 500 MPL flow cytometry systems with MXP software versions 2.0 & 2.1 MHRA

北京自然美光学有限公司亮洁倍润免揉搓去蛋白护理液、生产日期/批号06030015、规格360毫升

Beijing Health Inspection Website

上海海昌隐形眼镜光学有限公司海昌隐形眼镜多功能护理液、生产日期/批号20051027、规格500毫升广州保视宁光学产品有限公司保视宁去蛋白软性接触镜护理液、生产日期/批号2005/09/18、规格360毫升Alcon Opti-Free Express Contact Lens Care Solution (爱尔康杀菌全护理液), lot number #63188F and manufacturing date 2006/02







http://www.bjhi.com.cn/news.do?dispatch=readById&id=13803




N/A 1 affected unit was distributed in Hong Kong.




N/A








N/A

N/A




2724 2836




2806 4841 The local agent informed all the affected users.


2783 1838

2783 1838






N/A



N/A



2996 7650 The local agent has already informed all the concerned hospitals and doctors.

2735 8262 Updated on 2006/10/23. Please see SA060241 for details.

9262 1527



2576 2688 1 affected unit was distributed in Hong Kong.


(86)10-6202-3856 3 affected units were distributed in Hong Kong.

N/A





2891 2208

N/A








N/A



2376 1805

2735 8262 Update to SA060236. For enquiry, please contact the local agent.




N/A





N/A







N/A



N/A






Supersedes the MDA/2006/056 (Ref: SA060163). The manufacturer informed that no affected units had been distributed in Hong Kong.

According to FDA, distribution of affected units was limited to the United States only. Pending the manufacturer's confirmation.



2735 8262


N/A


2240 6260

N/A

N/A

N/A

2161 0888

Extension of the recall case # SA060238. The local agent informed that no affected units had been distributed in Hong Kong.

The State Food and Drug Administration (SFDA) of the PRC informed that, among the four brands, only the Alcon brand is sold in Hong Kong. Alcon Hong Kong Ltd. informed that the affected lot of its product was not distributed in Hong Kong.


Monthly Summary of Medical Device Safety Alerts - September 2006*Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, CanadaMDCO Ref. No. Description of Product Source of Information* Reference No. by Source Alert Type by Source Local Agent

SA060167 Gantry Direct Drive systems in Varian High Energy Clinac linear accelerators N/A Urgent Medical Device Correction 2006/09/01 Varian Medical Systems Pacific Inc.

SA060168 Zimmer-M/DN, Trilogy, HGP II and Herbert Bone Screws 2006/007/013/081/005 Field Safety Corrective Action 2006/09/01 Zimmer PTE Ltd. (Hong Kong branch)

SA060169 32097 Type II Recall 2006/09/04 Johnson & Johnson Medical Hong Kong

SA060170 32117 Type II Recall 2006/09/04 Smith & Nephew Healthcare Ltd.


SA060172 31891 Type II Recall 2006/09/04 BioMerieux China Limited

SA060173 Kueschall Airlite Manual Wheelchair, K Series 2005 32191 Type II Recall 2006/09/04 Direct Health Ltd.

SA060174 Boston Scientific PT2 Guide Wire Boston Scientific H. K. Ltd. N/A Urgent Medical Device Recall 2006/09/05 Boston Scientific H. K. Ltd.

SA060175 Baxter Healthcare Cryote Freezing Container 2006/008/031/081/004 Field Safety Corrective Action 2006/09/05 Baxter Healthcare Ltd.

SA060176 Dideco Electa and Compact Advanced Autotransfusion Wash Sets 2006/008/029/291/003 Field Safety Corrective Action 2006/09/05 N/A

SA060177 2006/009/004/291/014 Field Safety Corrective Action 2006/09/06 Dade Behring Hong Kong Ltd

SA060178 Radiometer America Transcutaneous Monitor for pO2 and pCO2, Model # TCM4 Z-1437-06 Class II Recall 2006/09/06 N/A

SA060179 BioGenex brand Hepatitis B Virus Core Antigen Antibody and Surface Antigen Antibody Z-1438-06 & Z-1439-06 Class II Recall 2006/09/06 Science International Corporation


SA060181 Radiometer America safePICO Samplers, self-filling arterial blood samplers Z-1443-06 Class II Recall 2006/09/06 N/A

SA060182 Delphi IVantage Volumetric Ambulatory Infusion Pump/System Z-1445-06 Class II Recall 2006/09/06 N/A

SA060183 BD Unopette System Tests for Erythrocyte Fragility Test Kit, catalog # 365830 Z-1446-06 Class II Recall 2006/09/06 Becton Dickinson Asia Ltd.

SA060184 Z-1448-06 to Z-1450-06 Class II Recall 2006/09/06 Bayer Healthcare Ltd. (Hong Kong)

SA060185 Pointe Scientific AutoHDL Cholesterol Reagent Sets, various models Z-1454-06 to Z-1459-06 Class II Recall 2006/09/06 Evergreen Health Care Ltd.

SA060186 Z-1464-06 & Z-1465-06 Class II Recall 2006/09/06 Bayer Healthcare Ltd. (Hong Kong)

SA060187 ELLA Esophageal Stent - Boubella-E, Boubella, Flexella 2006/006/014/601/150 Field Safety Corrective Action 2006/09/06 N/A

SA060188 Siemens Medical Solutions Siregraph CF 2006/008/015/121/001 Field Safety Corrective Action 2006/09/06 Siemens Ltd.

SA060189 2006/008/021/081/006 Field Safety Corrective Action 2006/09/07 Johnson & Johnson Medical Hong Kong

SA060190 Lumenis DuoTome SideLite 550 Micron Delivery System Boston Scientific H. K. Ltd. N/A Urgent Medical Device Recall 2006/09/08 Boston Scientific H. K. Ltd.

SA060191 Penlon Sigma Delta Sevoflurane Vaporizer 2006/008/010/401/007 Field Safety Corrective Action 2006/09/08 N/A

SA060192 Roche Diagnostics Elecsys Folate II assay on the Elecsys 2010 system 2006/008/024/081/004 Field Safety Corrective Action 2006/09/08 Roche Diagnostics (Hong Kong) Limited

SA060193 Sorin Group S5 Heart Lung Machine 2006/008/003/401/007 Field Safety Corrective Action 2006/09/08 N/A

SA060194 Intavent Orthofix Laryngeal mask airway 2006/009/004/291/003 Field Safety Corrective Action 2006/09/08 N/A



MHRA

Codman EDS III Drainage System, model or catalog # 82-1731, lot or serial # CGHBGC and CGHBGD Health Canada

Smith & Nephew Hewson Suture Retrievers Item 7111-1579, lot or serial # 05HSM0014 Health Canada

Mentor Clear Advantage With Aloe MECs, model or catalog # 26-06100, 26-06200, 26-06300, 26-06400 & 26-06500 Health Canada

Biomerieux Vitek 2 Compact 30 System, Vitek 2 Compact 60 System and Vitek 2 System Health Canada

Health Canada

MHRA

MHRA

Dade Behring Limited Dimension clinical chemistry system Tacrolimus (TACR) Flex reagent cartridge (DF107) Lots: FM6334, FD6344 and FA6351 MHRA

FDA

FDA

Diagnostica Stago Staclot LA 20 tests, Catalog #0594, LA Assay, Hexagonal Phase Phospholipid Neutralization Assay FDA

FDA

FDA

FDA

Bayer Healthcare ADVIA 1650, 1200 and 2400 Chemistry Systems, Automated Clinical Chemistry Analyzer - human serum, plasma and urine tests FDA

FDA

Bayer Healthcare RapidLab 1200 Systems, models 1245 and 1265 - blood gases, electrolyte and blood pH test systems FDA

MHRA

MHRA

Codman CSF External Drainage System III, 82-1731(EDS III without ventricular Catheter), Lot Nos.: CGHBGF, CGGCT5, CGGCT8, CGGCT9 MHRA

MHRA

MHRA

MHRA

MHRA



























SA060195 Celki Medical Company N/A 2006/09/09 Celki Medical Company


SA060197 Boston Scientific NAMIC Fluid Injection Line, batch/lot 2011867 Boston Scientific H. K. Ltd. N/A Urgent Medical Device Recall 2006/09/12 Boston Scientific H. K. Ltd.


SA060199 Z-1467-06 to Z-1480-06 Class II Recall 2006/09/13 Zimmer PTE Ltd. (Hong Kong branch)

SA060200 AGA Medical Amplatzer VSD Occluder 2006/007/017/291/008 Field Safety Corrective Action 2006/09/14 Beijing Since Medical Scientific Co. Ltd.

SA060159 Stryker Biotech Calstrux, model or catalog # 400-05CN, 400-10CN and 400-15CN 32208 Type I Recall 2006/09/18 Stryker Hong Kong

SA060160 Datex-Ohmeda Aisys Carestation, model or catalog # 1011-9000-000 32272 Type I Recall 2006/09/18 Hong Kong Oxygen & Acetylene Co. Ltd.

SA060201 Draeger Medical Infant Care Isolette C2000 Incubators, model or catalog # C2HS 32198 Type II Recall 2006/09/18 Draeger Medical Hong Kong Ltd.


SA060203 AMG Medical IV Pole, model or catalog number 775-855P and 775-860 32257 Type II Recall 2006/09/18 N/A

SA060204 AGFA IMPAX 5.2 System, model or catalog # IMPAX MA3000 32134 Type II Recall 2006/09/18 Agfa Hong Kong Ltd.

SA060205 GE OEC Medical Systems OEC Mini 6800 C-ARM, various lot or serial numbers 32268 Type II Recall 2006/09/18 GE Medical Systems Hong Kong Ltd.

SA060161 Lifescan OneTouch Ultra 2 Blood Glucose Meters MDA/2006/054 Immediate Action 2006/09/18 Johnson & Johnson Medical Hong Kong

SA060206 Z-1461-06 to Z-1463-06 Class II Recall 2006/09/20 Becton Dickinson Asia Ltd.

SA060207 Z-1487-06 Class II Recall 2006/09/20 Philips Electronics Hong Kong Ltd.

SA060208 Skytron General Purpose Surgical Table, Models 6600 and 6600B (battery model) Z-1496-06 & Z-1497-06 Class II Recall 2006/09/20 N/A

SA060209 Greiner bio-one Vacuette Tube, Item # 454332, lot # B050609 Z-1498-06 Class II Recall 2006/09/20 Mekim Ltd.

SA060210 Xiros Plc Neoligaments 6mm and 8mm Staple Impactors Z-1500-06 & Z-1501-06 Class II Recall 2006/09/20 N/A

SA060162 Ansell Ltd. Microtouch Ultra PF Examination gloves 2006/009/019/181/008 Field Safety Corrective Action 2006/09/20 N/A

SA060211 Hill-Rom Affinity Three Birthing Bed, Model P3700 Z-1503-06 Class II Recall 2006/09/22

SA060212 2006/009/015/131/001 Field Safety Corrective Action 2006/09/22 Smith & Nephew Healthcare Ltd.

SA060213 Huntleigh birthing beds, Models 35000 and 170000 2005/007/018/291/018 Field Safety Corrective Action 2006/09/22 N/A

SA060214 Hoskins Lifecare birthing beds- Models L05 an dL10 2005/007/018/291/018 Field Safety Corrective Action 2006/09/22 N/A

SA060215 Smith and Nephew TC100 2.7mm Cortical Bone Screws 2006/009/020/291/027 Field Safety Corrective Action 2006/09/22 Smith & Nephew Healthcare Ltd.

SA060216 Biosense Webster Europe RefStart Catheter with QwikPatch External Reference Patch 2006/009/022/291/010 Field Safety Corrective Action 2006/09/25 Johnson & Johnson Medical Hong Kong

SA060217 Boston Scientific Flexima all purpose drainage catheters, lot number 8955327 Boston Scientific H. K. Ltd. N/A Urgent Medical Device Recall 2006/09/26 Boston Scientific H. K. Ltd.

SA060218 Eschmann Equipment Ltd. Narrow Split Plate Connector 2006/009/011/601/207 Field Safety Corrective Action 2006/09/26 N/A

SA060219 GE Precision 500D Radiographic and Fluoroscopic Imaging System, all serial numbers Z-1304-06 Class II Recall 2006/09/27 GE Medical Systems Hong Kong Ltd.

SA060220 BD BBL Staphyloslide Latex Test Kit, Catalog # 240952 and 240953 Z-1505-06 Class II Recall 2006/09/27 Becton Dickinson Asia Ltd.

Respironics NICO model 7300 Cardiopulmonary Management System - serial numbers beginning with 138-

Important Medical Device Recall Notification

Applied Medical Technology Endovive Enteral Feeding Device, lot/batch number 6040734

Radiometer America D826 Accessory kit for single tcpO2 Electrodes for use with the TCM400 Transcutaneous Monitor (Cutaneous Oxygen Monitor) Part Number: 904-308 FDA

Zimmer VERSYS, MAYO and ZMR Hip Prosthesis Systems Femoral Stem and Body, various sizes FDA

MHRA

Health Canada

Health Canada

Health Canada

Baxter Healthcare Continu-Flo Sets With Check Valve, various models or catalog numbers Health Canada

Health Canada

Health Canada

Health Canada

MHRA

BD Vacutainer Blood Collection Assembly with BD Blunt Plastic Cannula, Vacutainer Luer Adapter and Direct Draw Adapters FDA

Philips Medical Systems IntelliVue MultiMeasurement Server (MMS)/Multimeasurement Server, physiological patient monitoring system. Model: M3001A

FDA

FDA

FDA

FDA

MHRA

FDA (1) Solar-Med Ltd; (2) Goodman Medical Supplies Ltd.

Smith and Nephew Genesis II Non-porous fin Stem Tibial Punches, Codes 711440480, 71440482, 71440484 and 71440486 MHRA

MHRA

MHRA

MHRA

MHRA

MHRA

FDA

FDA


















http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?ID=48066










SA060221 Conmed System 2500 and 5000 Electrosurgical Units Z-1507-06 & Z-1508-06 Class II Recall 2006/09/27 N/A

SA060222 Invacare Solara 2G, Spree GT and Spree XT (SPRXT) manual wheelchairs Z-1509-06 to Z-1511-06 Class II Recall 2006/09/27 Direct Health Ltd.

SA060223 Stryker Power-Pro Powered Ambulance Cot, Model 6500 Z-1513-06 Class II Recall 2006/09/27 Stryker Hong Kong

SA060224 Kerr Optibond Solo Plus Self-Etch Adhesive System, Part Number 31966 Z-1521-06 Class II Recall 2006/09/27 N/A

SA060225 Beckman Coulter LH700 series Hematology Analyzers 2B3 2B4 and 2B5 Software 2006/009/022/291/004 Field Safety Corrective Action 2006/09/27 Beckman Coulter Hong Kong Ltd.

SA060226 GE Healthcare Technologies Gas absorbers Compact Absorber 427002000 2006/009/005/601/267 Field Safety Corrective Action 2006/09/27 GE Medical Systems Hong Kong Ltd.

SA060227 2006/009/025/291/001 Field Safety Corrective Action 2006/09/27 Smiths Medical (S.E. Asia) Ltd.


SA060229 Becton Dickinson Asia Ltd. N/A Worldwide Medical Device Recall 2006/09/28 Becton Dickinson Asia Ltd.

SA060230 Abbott Laboratories FSH calibrator and AsSY Master calibrator batches 2006/009/027/601/314 Field Safety Corrective Action 2006/09/28 Abbott Laboratories Ltd.

SA060231 Abbott Laboratories CELL-DYN Sapphire List Number 08H00-01 2006/008/025/601/253 Field Safety Corrective Action 2006/09/28 Abbott Laboratories Ltd.

SA060163 Sunrise Medical Jay J2, Wheelchair back MHRA MDA/2006/056 Action 2006/09/28 N/A

SA060164 CryoCath Technologies, Inc. N/A Market Withdrawal 2006/09/28 Pacific Medical (HK) Ltd.

SA060165 Advanced Medical Optics, Inc. N/A Voluntary Limited Market Recall 2006/09/28 AMO Asia Limited

SA060232 Coloplast Drainage bag - 5062 - Conveen Urine Bag, 1500ml, 90cm tube 2006/009/019/181/006 Field Safety Corrective Action 2006/09/29 N/A

SA060233 Micrus Endovascular Watusi Guide Wire System 2006/009/019/181/004 Field Safety Corrective Action 2006/09/29 N/A

SA060234 Hill-Rom Dynamis LI140, I148, LI150; Gerialit LI114, LI1245, LI146, LI163 2006/009/004/291/006 Field Safety Corrective Action 2006/09/29 N/A

SA060235 Sendal S.A/Arcomedical Infusion Ltd, Volumed 310PK2J 2006/009/025/401/010 Field Safety Corrective Action 2006/09/29 N/A

SA060238 N/A Press Release 2006/09/29 Johnson & Johnson Medical Hong Kong

FDA

FDA

FDA

FDA

MHRA

MHRA

Smiths Medical Chest Drain - Portex Chest Drainage System with Adjustable Straw - 2000ml MHRA

Boston Scientific Vaxcel Implantable Chest Ports with PASV Valve Technology, specific lots

BD Tube, 14mL 17x100mm PS W/SN CAP 25/PAC, lot # 6152968 and BD Procount (IVD), lot # 340398

MHRA

MHRA

CryoCath Arctic Circler Curvilinear Cardiac Cryoablation Catheters, catalog nos. 2AC20, 2AC22, 2AC24, 2AC26 and 2AC30

AMO COMPLETE Amino Moist Multi-Purpose Solution, 360mL x 2, lot numbers ZB02542, ZB02563, ZB02567 and ZB02575

MHRA

MHRA

MHRA

MHRA

LifeScan Inc. SureStep Pro (part #010-797, lot #2634187008) and OneTouch SureStep (part #020-052, lot #2627353) Blood Glucose Test Strips LifeScan Inc.














http://www.lifescan.com/company/about/press/suresteppro1006/





2992 0968




2356 7033 3 affected units were distributed in Hong Kong.





2803 0118











2870 7533 2 affected units in Hong Kong.








2268 9258 2 affected units in Hong Kong. Rectification programme has been completed.





9262 1527 The local agent will inform all the future users about the concerned issue.







2783 1838








(1) 2425 0926; (2) 2332 4455 15 affected units in Hong Kong. Rectification programme completed.


N/A













2240 6260







N/A Superseded by MDA/2006/060.



N/A


N/A




Monthly Summary of Medical Device Safety Alerts - August 2006*Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, CanadaMDCO Ref. No. Description of Product Source of Information* Reference No. by Source Alert Type by Source Local Agent

SA060070 Biotronik - Stratos LV-T Pacemaker 2006/007/027/291/016 Field Safety Corrective Action 2006/08/01 N/A

SA060071 2006/006/026/131/002 Field Safety Corrective Action 2006/08/01 Dade Behring Hong Kong Ltd

SA060072 MDA/2006/043 Action 2006/08/02 Becton Dickinson Asia Ltd.

SA060073 AFOS Ltd. Endoscope storage facility (ESF) MDA/2006/044 Action 2006/08/02 N/A

SA060074 SCC Soft Computer SoftPath ASXII Software Releases 2.3.0 and 4.3.7 Z-1243-06 Class II Recall 2006/08/02 N/A

SA060075 SCC Soft Computer SoftPath ASCII Software, Releases 1.2, 2.1, and 2.3 Z-1252-06 Class II Recall 2006/08/02 N/A

SA060076 Z-1255-06 Class II Recall 2006/08/02 Brainlab Ltd. (Hong Kong)



SA060079 Radiometer America Dri-Tex BG-OX Cartridge, Model # D7120 Z-1261-06 Class II Recall 2006/08/02 N/A


SA060081 Microcuff Pediatric and Adult Endotracheal Tubes, various sizes Z-1263-06 to Z-1265-06 Class II Recall 2006/08/02 N/A

SA060082 Z-1266-06 & Z-1267-06 Class II Recall 2006/08/02 Terumo China (H.K.) Ltd.

SA060083 Z-1268-06 to Z-1270-06 Class II Recall 2006/08/02 Varian Medical Systems Pacific Inc.

SA060084 Zimmer Trabecular Metal Shoulder Instrumentation Distal Pilot, various sizes Z-1271-06 to Z-1285-06 Class II Recall 2006/08/02 Zimmer PTE Ltd. (Hong Kong branch)


SA060086 Corin Ltd. Standard Neck Modular Head 28mm 2006/007/031/601/190 Field Safety Corrective Action 2006/08/03 N/A

SA060087 2006/007/003/291/017 Field Safety Corrective Action 2006/08/03 Bio-Gene Technology Ltd.

SA060088 Abbott Laboratories Cystic Fibrosis V3 Genotyping Assay 2006/008/001/601/092 Field Safety Corrective Action 2006/08/03 Abbott Laboratories Ltd.

SA060089 Technovent Optical Conformer Impression Conformer 2006/007/031/081/009 Field Safety Corrective Action 2006/08/04 N/A


SA060091 Tomotherapy Incorporated HI-ART System, Lot or Serial # 10009, 10037 and 10014 31533 Type II Recall 2006/08/07 N/A

SA060092 Medrad Neurovascular Array Coils, model or catalog # M64NVA 31863 Type II Recall 2006/08/07 Ultronics Enterprise Ltd.

SA060093 GE Healthcare Innova 2100IQ, lot or serial # 469545BU6 and 479238BU8 31920 Type II Recall 2006/08/07 GE Medical Systems Hong Kong Ltd.


SA060065 31344 Type I Recall 2006/08/07 N/A

SA060066 31892 Type I Recall 2006/08/07 Tyco Healthcare (HKSAR) Limited

SA060095 Roche Diagnostics GGT/IFCC Granulate Reagent 2006/007/013/291/005 Field Safety Corrective Action 2006/08/07 Roche Diagnostics (Hong Kong) Limited


MHRA

Dade Behring N Rheumatology Standard SL for RF, N/T Rheumatology Control SL/1 and SL/2 for RF on BN System MHRA

Becton Dickinson Vacutainer Direct Draw adaptor product code 364896 and Vacutainer Luer adaptor product code 367300 MHRA

MHRA

FDA

FDA

Brainlab ExacTrac Robotics for installation on the Varian Exact Couch, a component of the Novalis Shaped Beam Surgery System FDA

St. Francis Medical Technologies brand X STOP® Interspinous Process Decompression (IPD) System FDA

Radiometer America Waste tubing, Model # 842-326 (pump tube for waste) and Model # 842-327 (pump tube for solution) FDA

FDA

Radiometer America Radiance Data Management System Software Version 2.42 (Stand-alone software package) for the Radiance STAT Analyzer Management System FDA

FDA

Terumo Advanced Perfusion System 4 inch diameter Roller Pump (model 801040) and 1 Large Roller Pump (model 801041) FDA

Varian Medical Systems Gamma Win software, part number GM11019110, versions up to and including 1.62 FDA

FDA

LifeCell Repliform Tissue Regeneration Matrix, catalog numbers 820241, 820245 and 820246

MHRA

the Binding Site, Freelite human kappa free kit & human lambda free kit assays used on Hitachi & BNII instruments MHRA

MHRA

MHRA

Integra Neurosciences Ultrasonic surgical Aspirator System, model or catalog # 1529161 and 1529165 Health Canada

Health Canada

Health Canada

Health Canada

Sunrise Medical CCG Joerns Ultracare Model 770 AC Powered beds, model or catalog # U770, U770-GNDAL and U770AL Health Canada

BHM Medical Reacher for Transportable Ceiling Lift, Model or Catalog # 700.08310 and 700.08320 Health Canada

Nellcor Puritan Bennett Satin-Slip Intubating Stylet, Model or Catalog # 85863, Lots beginning with 05 and 06 Health Canada

MHRA





























SA060096 Smiths Medical International-Custom Epidural Pack 2006/007/031/081/001 Field Safety Corrective Action 2006/08/07 Smiths Medical (S.E. Asia) Ltd.

SA060097 Smiths Medical Catheter, central venous 2006/007/027/291/010 Field Safety Corrective Action 2006/08/07 Smiths Medical (S.E. Asia) Ltd.

SA060098 2006/007/013/291/004 03a Field Safety Corrective Action 2006/08/07 Baxter Healthcare Ltd.

SA060099 Medtronic Midas Rex Classic GS and Legend dissecting tools 2006/008/002/291/003 Field Safety Corrective Action 2006/08/09 Medtronic International, Ltd.

SA060100 Sedana Medical AnaConDa Anaesthetic conserving device MDA/2006/045 Action 2006/08/09 N/A

SA060101 Kensey Nash TriActiv ProGuard Embolic Protection System, part number 61000-01 Z-1305-06 Class II Recall 2006/08/09 N/A

SA060102 Applied Biotech Medplus ER Drug Screen Test, Model # 5800KAB Z-1315-06 Class II Recall 2006/08/09 N/A


SA060104 CryoCath Technologies Ltd. N/A Field Safety Corrective Action 2006/08/10 Pacific Medical (HK) Co. Ltd.


SA060106 DeSoutter Medical, Sagittal Blade-Opposed Tooth 2006/008/004/081/002 Field Safety Corrective Action 2006/08/10 N/A

SA060107 Days Healthcare Strider Maxi 3, Maxi 4 & Maxi 4 Plus 2006/003/001/261/001 Field Safety Corrective Action 2006/08/11 N/A


SA060109 Respironics Esprit Ventilator Power Supply Celki Medical Company N/A Urgent Field Action Notification 2006/08/14 Celki Medical Company

SA060110 Gambro Renal Prismaflex Continuous Renal Relacement System, Model 6023014700 2006/007/031/081/014 Field Safety Corrective Action 2006/08/14 Gambro China Ltd.

SA060111 Boston Scientific vanSonnenberg Sump Catheter, lot/batch number 8606405 Boston Scientific H. K. Ltd. N/A Urgent Medical Device Recall 2006/08/16 Boston Scientific H. K. Ltd.

SA060112 Richard Wolf Single Use Tem Tubing Sets, Type 4170.801 - Batch 060232 2006/008/015/081/011 Field Safety Corrective Action 2006/08/16 N/A

SA060113 Abbott brand FreeStyle and FreeStyle Flash Blood Glucose Meters Z-1306-06 & Z-1307-06 Class II Recall 2006/08/16 Abbott Laboratories Ltd.

SA060114 MediSurg Fugo Blade Incising Tip Assembly Z-1224-06 Class II Recall 2006/08/16 N/A






SA060120 Zimmer sterile bone screws, various models and sizes Z-1335-06 to Z-1351-06 Class II Recall 2006/08/16 Zimmer PTE Ltd. (Hong Kong branch)

SA060121 Edwards Lifesciences Aquarius Heamofiltration machine 2005/005/006/401/010 Field Safety Corrective Action 2006/08/17 N/A

SA060122 Medicina Infant Feeding Tubes 2006/007/010/291/007 Field Safety Corrective Action 2006/08/18 N/A

SA060067 31495 Type I Recall 2006/08/21 Roche Diagnostics (Hong Kong) Limited

SA060068 Gambro Prismaflex Continuous Renal Replacement System 31616 Type I Recall 2006/08/21 Gambro China Ltd.

SA060123 32029 Type I Recall 2006/08/21 Bio-Rad Pacific Ltd.

MHRA

MHRA

Baxter Healthcare Blood cell separator Amicus Apheresis Kit (Lot A06C21046, A06D10088, A06D10237, A06D25060) MHRA

MHRA

MHRA

FDA

FDA

Radiometer Medical Aps Capilliary blood sample tube caps contained in safe clinitube kits MHRA

CryoCath Arctic Circler curvilinear cardiac cryoablation catheters, catalog no. 2AC30 and lot nos. 50103, 50312, 50327, 50418, 00035, 00169, 00486

Therakos Therakos UVARXTS small bowl procedural kit (Catalog No. XT125). Lot nos. U706, U707, U708, U709, U710, U711, U712 MHRA

MHRA

MHRA

Coloplast A/S, Simpla Al Silicone Indwelling Catheters Code: 367516 Male Ch16 Lot 696770 MHRA

MHRA

MHRA

FDA

FDA

Tekia TEKLENS II (TEKIA label) and Polylens A60 (Polytech label) Model 614 intraocular lens FDA

ArthroCare OPUS Speedstitch Suture Cartridge with Magnumwire, Catalog number OM-6006 FDA

Radiometer America Blood Gas and Co-Ox Electrolyte & Metabolyte Analyzer, ABL-700 and ABL-800 Series FDA

Radiometer America Capillary (end) caps, accessory for use with blood gas analyzers included in Radiometer's CLINITUBES kits, Model # 904-439 and 904-453 FDA

Pointe Scientific Liquid Glucose HEX(R1), HEX(R2), HEX and HEXO Reagents and Reagent Sets FDA

FDA

MHRA

MHRA

Roche Diagnostics Accu-chek Advantage for Accudata GTS, Accu-Soft & Accu-Chek Advantage Blood Glucose Meters Health Canada

Health Canada

Bio-Rad Laboratories Genetic System HIV-2 EIA, Model or Catalog # 32536, lot or serial # 032AY1 & 139AY1 Health Canada





























SA060124 Beckman Coulter FP1000 Cell Preparation System, model or catalog # 624922 31805 Type II Recall 2006/08/21 Beckman Coulter Hong Kong Ltd.


SA060126 Osmetech OPTI CCA Blood Gas & Electrolyte Analyz 32028 Type II Recall 2006/08/21 N/A

SA060127 Smiths Medical Hotline L-10 Gas Vent 32033 Type II Recall 2006/08/21 Smiths Medical (S.E. Asia) Ltd.

SA060128 Smith & Nephew Electroblade Resector 4.5, 4.5 Elite/FR and Trivex Resector Kit 31890 Type II Recall 2006/08/21 Smith & Nephew Healthcare Ltd.


SA060130 Siemens Arcadis Orbic and Arcadis Varic, model or catalog # 8081080 and 8080017 32040 Type II Recall 2006/08/21 Siemens Ltd.

SA060131 Siemens Lithoskop, model or catalog # 8355088, lot or serial # 1019 32043 Type II Recall 2006/08/21 Siemens Ltd.

SA060132 Nomos (North American Scientific) Corvus Planning System 6.0/6.1 32048 Type II Recall 2006/08/21 N/A

SA060133 31389 Type II Recall 2006/08/21 Goodman Medical Supplies Ltd.

SA060134 Maquet Critical Care HL30 Perfusion System 31875 Type II Recall 2006/08/21 Maquet Hong Kong Limited

SA060135 Gambro Prismaflex Modele 6023014700, all serial numbers 32059 Type II Recall 2006/08/21 Gambro China Ltd.

SA060136 32092 Type II Recall 2006/08/21 Siemens Ltd.

SA060137 Beckman Coulter Unicel DxI 800 Access Immunoassay System Wash Buffer 2006/008/016/081/005 Field Safety Corrective Action 2006/08/21 Beckman Coulter Hong Kong Ltd.

SA060138 Bayer Healthcare ADVIA Centaur CP Immunoassay Analyser 2006/008/015/121/002 Field Safety Corrective Action 2006/08/21 Bayer Healthcare Ltd. (Hong Kong)


SA060140 Z-1377-06 to Z-1384-06 Class II Recall 2006/08/22 Roche Diagnostics (Hong Kong) Limited

SA060141 MDA/2006/046 Immediate Action 2006/08/22 N/A

SA060142 Maquet Critical Care AB Heart Lung Machines HL20 and HL30 2006/008/022/081/011 Field Safety Corrective Action 2006/08/23 Maquet Hong Kong Limited

SA060143 Roche Tina-Quant ASLO (Anti-streptolysin O) Reagent Kit, Catalog No. 1931601 Z-1385-06 Class II Recall 2006/08/23 Roche Diagnostics (Hong Kong) Limited


SA060145 Z-1388-06 to Z-1397-06 Class II Recall 2006/08/23 Evergreen Health Care Ltd.

SA060146 Z-1398-06 & Z-1399-06 Class II Recall 2006/08/23 Varian Medical Systems Pacific Inc.

SA060147 Z-1401-06 Class II Recall 2006/08/23 Siemens Ltd.

SA060148 Baxter Intermate and Infusor Large volume (LV) infusion pumps - all models MDA/2006/048 Action 2006/08/24 Baxter Healthcare Ltd.

SA060149 Cardinal Health Alaris SE Pump (formerly Signature Edition Infusion Pump), all models N/A Press Release 2006/08/28 The Vita Company Ltd.

SA060150 Chiltern Invadex ceiling track patient hoists with turntables MDA/2006/050 Action 2006/08/29 N/A

SA060151 B Braun Aesculap NC 464T and NC468T Acetabular cups 2006/008/021/291/006 Field Safety Corrective Action 2006/08/30 B. Braun Medical (Hong Kong) Ltd.

SA060152 Z-1410-06 Class II Recall 2006/08/30 Hong Kong Oxygen & Acetylene Co. Ltd.

Health Canada

Baxter Healthcare Arena SPP and SPX Hemodialysis Delivery Systems, Hemodialysis Machine 1550, Machine 1550 Single Needle Hemodialysis and System 1000 Dialysate Delivery System, all serial numbers

Health Canada

Health Canada

Health Canada

Health Canada

Edwards Lifesciences Vascushunt Silicone Balloon Shunt, model or catalog # T3103AS, lot or serial # 58220388 Health Canada

Health Canada

Health Canada

Health Canada

Fujinon Mobile Endoscopy Cart, lot or serial # 125769, 125770, 125774, 125767 and 125772 Health Canada

Health Canada

Health Canada

Siemens Medical Solutions Oncology Care Systems ZXT Treatment Table, model or catalog # 9820952 and 05844621 Health Canada

MHRA

MHRA

Cordis Neurovascular Pre-shaped Prowler and pre-shaped PROWLER SELECT infusion catheters MHRA

Roche Diagnostics Accu-chek Comfort Curve, Advantage, Sensor Comfort and Inform Blood Glucose Meter Test Strips FDA

Orthopaedic implants manufactured by Proconcept SA France: CIFEC cervical cages; LIFEC lumbar cagesl ALIFEC lumbar cages; SRE/SEO spinal screw systems; CANALETTO carpal tunnel protection implants

MHRA

MHRA

FDA

Radiometer America Blood Gas and Co-Ox2 Electrolyte & Metabolyte Analyzers, ABL-700 and ABL-800 Series FDA

Pointe Scientific Alkaline Phosphatase reagents, buffers and substrates, various models FDA

Varian Medical Systems GammaMed software programs for the GammaMed models 12i and 12it radionuclide applicator systems FDA

Siemens LANTIS XLINK (Impac MultiAccess Sequencer) on Varian accelerators with the MLC3PI interface FDA

MHRA

FDA

MHRA

MHRA

INO Therapeutics (Datex Ohmeda) INOvent Nitric Oxide Delivery System, Model Number 1605-9000-000 FDA

















http://www.accu-chek.com/en_US/pdf/Desiccant_UPR__Final_.pdf














SA060153 Zimmer Trabecular Metal Reverse Shoulder System Glenosphere and Base Plate Z-1416-06 to Z-1418-06 Class II Recall 2006/08/30 Zimmer PTE Ltd. (Hong Kong branch)

SA060154 BioCare Systems LumiWave 1X4 Infrared Therapy Device, Catalog # LW1X4 Z-1419-06 Class II Recall 2006/08/30 N/A




SA060069 Medtronic LIFEPAK 20 Defibrillator/Monitors N/A Urgent Medical Device Correction 2006/08/31 Medtronic International, Ltd.

SA060158 Abbott Laboratories Xsystems CA 15-3 controls 2006/008/023/291/007 Field Safety Corrective Action 2006/08/31 Abbott Laboratories Ltd.

FDA

FDA

A & E Industries Guardian Walker and Guardian 5 inch Walker Wheel Kits, various models FDA

Cobe Optima XP Hollow Fiber, CML Duo Flat Sheet and Optimin Hollow Fiber Sealed System Membrane Oxygenators/Reservoirs, various models FDA

MicroVision Medical MicroScan Lens Disposable Plastic Cap used with MicroScan Video Microscope FDA

Medtronic International, Ltd.

MHRA






http://www.medtronic-ers.com/notices/20-v38





N/AThe manufacturer informed that no affected units had been distributed in Hong Kong.

2803 0118The manufacturer informed all the affected users.



N/A

N/A












2646 6101 The manufacturer informed all the affected users.



N/A





N/A


















2576 2688


N/A











2485 7510



For further details, please see the website notice: http://www.mdco.gov.hk/english/recalls/recalls_20060828.html

http://www.mdco.gov.hk/english/recalls/recalls_20060828.html















2240 6260




N/A


















2919 1362 5 affected units in Hong Kong. Rectification completed.



Monthly Summary of Medical Device Safety Alerts - July 2006*Note: FDA = Food and Drug Administration, United States of America; MHRA = Medicines and Healthcare products Regulatory Agency, United Kingdom; Health Canada = Health Canada, CanadaMDCO Ref. No. Description of Product Source of Information* Reference No. by Source Alert Type by Source Local Agent

SA060001 Boston Scientific Expo and Impulse Angiographic Catheter N/A Urgent Medical Device Recall 2006/07/03 Boston Scientific Hong Kong Ltd.

SA060002 Adept-Med brand Glassman Viscera Retainer FISH Z-1156-06 Class II Recall 2006/07/05 Solar Medical Ltd.


SA060004 Z-1161-06 Class II Recall 2006/07/05 BioMerieux China Limited

SA060005 Leica M520 Surgical Microscope Z-1162-06 Class II Recall 2006/07/05 Leica Microsystems Ltd. (Hong Kong)

SA060006 B. Braun 9F (O/S) Locking Tearway Introducers, non-sterile, Catalog number 614008 Z-1163-06 Class II Recall 2006/07/05 B. Braun Medical (Hong Kong) Ltd.

SA060007 Z-1164-06 to Z-1168-06 Class II Recall 2006/07/05 St. Jude Medical (Hong Kong) Ltd.

SA060008 Roche Calcium Reagent Kit for use on the Cobas MIRA Chemistry System Z-1176-06 Class II Recall 2006/07/05 Roche Diagnostics (Hong Kong) Limited

SA060009 Welch Allyn PIC 50 external defibrillator/monitor Z-1195-06 Class I Recall 2006/07/07 N/A

SA060010 Boston Scientific Urovac bladder evacuator N/A Urgent Medical Device Recall 2006/07/07 Boston Scientific Hong Kong Ltd.

SA060011 Boston Scientific Carotid WALLSTENT endoprothesis with Monorail delivery system N/A Urgent Medical Device Recall 2006/07/08 Boston Scientific Hong Kong Ltd.

SA060012 Cook Malleable Tip Filiform, model or catalog # 110245 31746 Type II Recall 2006/07/10

SA060013 Cook Duette Multi Band Mucosectomy Kit, model or catalog # DT-6 31750 Type II Recall 2006/07/10

SA060014 31742 Type II Recall 2006/07/10 Beckman Coulter Hong Kong Ltd.

SA060015 Coopersurgical 60cc Handy-Vak Locking Syringe, model or catalog # MX 500 30621 Type II Recall 2006/07/10 N/A

SA060016 31622 Type II Recall 2006/07/10 Bio-Rad Pacific Ltd.

SA060017 Plus Orthopedics Femoral Clamp TKR (slim) 2006/006/022/291/010 Field Safety Corrective Action 2006/07/10 N/A

SA060018 Gyrus ACMI PKS PlasmaSEAL Open Forceps, model 2103PK and 917015PK Z-1175-06 Class II Recall 2006/07/12 N/A

SA060019 Z-1178-06 to Z-1184-06 Class II Recall 2006/07/12 MDS Nordion (Hong Kong)





SA060024 Z-1191-06 Class II Recall 2006/07/12 Celki Medical Company

SA060025 Spacelabs Medical 1400 MHz Telemetry System,. Model 91341-09 Z-1202-06 Class II Recall 2006/07/12 Suburfarm Investment & Trading Co. Ltd.

SA060026 Siemens 3D-I/III Ceiling Stand, Diagnostic x-ray tube mount Z-1205-06 Class II Recall 2006/07/12 Siemens Medical Solutions Ltd.

SA060027 Cardinal Health Extension Set Model G304020M and G400200B 2006/007/010/291/024 Field Safety Corrective Action 2006/07/12 N/A


Boston Scientific Hong Kong Ltd.

FDA

Suros Surgical ATEC Breast Biopsy and Excision System Needle Guide, 9 GA, sterile, in packages of 5, Ref ATEC NG09 FDA

Biomerieux OBSERVA R02 (version R02.00.17) computers using PSC 6000 or HHP Barcode Scanners connected to BacT/ALERT 3D FDA

FDA

FDA

St. Jude Medical CPS Slitter, Valve Bypass Tool (VBT), Direct SL, Aim and Implant Kit, various models FDA

FDA

FDA



Health Canada (1) Cook Asia (Hong Kong) Ltd.; (2) A.R. Burkhill & Sons (Hong Kong) Ltd.

Health Canada (1) Cook Asia (Hong Kong) Ltd.; (2) A.R. Burkhill & Sons (Hong Kong) Ltd.

Beckman Coulter UniCel DxC 600, 600i and 800 Synchron Clinical Systems, model or catalog # A20463, A27331 and A29764 Health Canada

Health Canada

Bio-Rad Laboratories Diagnostics Group Liquichek Pediatric Control, model or catalog # 353X, 354 and 355 Health Canada

MHRA

FDA

MDS Nordion Theratron 780C, 780E, 1000, 1000E, Phoenix, Elite 80 and Elite 100 Cobalt Radiotherapies FDA

Terang Nusa Sterile Triumph LT Latex Powder-Free Surgeons Gloves, lot number T502504322 FDA

ArthroCare OPUS Smartstitch Suture Cartridge (catalog number OM-8071) and Smartstitch Magnum Wire Suture Cartridge (catalog number OM-8075) FDA

Sorenson Medical ambIT Ambulatory Infusion Therapy Intermittent Pump, catalog number 220245 FDA

Southmedic Vapofils with Stainless Steel Block Ends, Item Numbers V0507F (Isoflurane) and V0507S (Sevofluane) FDA

Respironics NeoPAP Neonatal CPAP/Humidification System (Ventilator, Continuous), model number 1025310 FDA

FDA

FDA

MHRA


























SA060028 Hand pendants of Varian C-Series Clinac linear accelerators Z-1206-06 Class II Recall 2006/07/12 Varian Medical Systems Pacific Inc.

SA060029 Disetronic D-TRONplus power packs used in D-TRONplus insulin pumps N/A Firm Press Release 2006/07/13 Roche Diagnostics (Hong Kong) Limited

SA060030 Rocket Sekdubger Chest Drainage Set 2006/007/003/291/024 Field Safety Corrective Action 2006/07/13 N/A

SA060031 EMS Swiss LithoClast Ultra ultrasound handpiece kit N/A Urgent Medical Device Recall 2006/07/14 Boston Scientific Hong Kong Ltd.

SA060032 Bio Stat Gentamicin Calibrator 2006/006/016/401/017 Field Safety Corrective Action 2006/07/14 N/A

SA060033 Joint Replacement Instrumentation Ltd. Brill Bit 2006/007/003/291/014 Field Safety Corrective Action 2006/07/14 N/A

SA060034 Wako Chemical Lp(a) Calibrator (Code No. 417-41491) Lot 52F5 2006/007/013/081/004 Field Safety Corrective Action 2006/07/14 N/A

SA060035 Baxter Healthcare Blood cell separator Amicus Apheresis Kit 2006/007/013/291/004 Field Safety Corrective Action 2006/07/17 Baxter Healthcare Ltd.

SA060036 GE Healthcare S/5 Anesthesia Delivery Unit Fresh Gas Control (A-FGC1) Unit Z-1196-06 Class II Recall 2006/07/19 GE Medical Systems Hong Kong Ltd.

SA060037 Sammons Preston Rolyan ValueLine and Midland Mat Platforms, various models Z-1207-06 to Z-1211-06 Class II Recall 2006/07/19 N/A


SA060039 Kensey Nash TriActiv System Procedure Kit and Balloon Inflation Syringe Z-1219-06 to Z-1221-06 Class II Recall 2006/07/19 N/A

SA060040 International Biophysics Corporation (IBC) Suction Handle (Sterile), part # 1990S Z-1222-06 Class II Recall 2006/07/19 N/A

SA060041 International Biophysics Corporation (IBC) FloProbe (Non-sterile), part # 3080N Z-1223-06 Class II Recall 2006/07/19 N/A

SA060042 Bard 8F Bard Channel Steerable Shealth 2006/007/017/601/173 Field Safety Corrective Action 2006/07/19 N/A

SA060043 Medtronic Model 7428 Kinetra Implantable Neurostimulator Medtronic International, Ltd. N/A Voluntary Field Corrective Action 2006/07/19 Medtronic International, Ltd.

SA060044 N/A 2006/07/21 Medtronic International, Ltd.

SA060045 Cardinal Health (formerly known as ALARIS) IVAC P4000 Syringe pump MDA/2006/042 Action 2006/07/24 N/A

SA060046 CIBA Vision Clerz 15ml, lot or serial # 48329 28894 Type II Recall 2006/07/24 Novartis Pharmaceuticals (HK) Ltd.

SA060047 Oxoid Imipenem 10ug Discs 31477 Type II Recall 2006/07/24 South East Chemicals & Instruments Ltd.

SA060048 31861 Type II Recall 2006/07/24 Terumo China (H.K.) Ltd.


SA060050 N/A Urgent Medical Device Recall 2006/07/25 Boston Scientific Hong Kong Ltd.


SA060052 Smith & Nephew TriVex Resector Kits, various models Z-1226-06 to Z-1229-06 Class II Recall 2006/07/26 Smith & Nephew Healthcare Ltd.

SA060053 Smith & Nephew Dyonics Electroblade 4.5, various models Z-1230-06 to Z-1233-06 Class II Recall 2006/07/26 Smith & Nephew Healthcare Ltd.

SA060054 3M Nexcare First Aid High Performance Gauze Pad Z-1234-06 Class II Recall 2006/07/26 3M Hong Kong Ltd.

SA060055 Gore Tag Thoracic Endoprosthesis Systems Z-1236-06 & Z-1237-06 Class II Recall 2006/07/26 W.L. Gore & Associates (Hong Kong) Limited

SA060056 Aksys PHD Personal Hemodialysis System for daily home hemodialysis, Model 1M101 Z-1239-06 Class II Recall 2006/07/26 N/A

SA060057 Cordis INFINITI 6 French Diagnostic Catheter Z-1240-06 Class II Recall 2006/07/26 Johnson & Johnson (Medical) Hong Kong Ltd.

SA060058 Z-1246-06 & Z-1247-06 Class II Recall 2006/07/26 Instrumentation Laboratory Ltd.

FDA

FDA

MHRA


MHRA

MHRA

MHRA

MHRA

FDA

FDA

Vanguard Medical Concepts Reprocessed Ethicon Bladeless Trocars, model 35NLT, 35NST, 35OL FDA

FDA

FDA

FDA

MHRA

Medtronic Model 8731 intrathecal catheters and model 8598 intrathecal catheter distal revision kits FDA Urgent: Worldwide Medical Device

Recall

MHRA

Health Canada

Health Canada

Terumo Cardiovascular Systems Advanced Perfusion System 1-Centrifugal and 1-Roller Pump Health Canada

Bellco Formula, Formula 2000, Formula 2000 Domus, Formula 2000 Plus and Formula 2000 Plus Domus Hemodialysis Health Canada

Boston Scientific Cutting Balloon Ultra2 Monorail Device Boston Scientific Hong Kong Ltd.

Teleflex Medical Green Spec Fiberoptic Laryngoscope Handle -- Stubby/Short, catalog number 004413300 FDA

FDA

FDA

FDA

FDA

FDA

FDA

Instrumentation Laboratory HemosIL and Hemoliance RecombiPlasTin, Prothrombin Time Test FDA


http://www.fda.gov/oc/po/firmrecalls/disetronic07_06.html













http://www.fda.gov/medwatch/safety/2006/safety06.htm#Catheter















SA060059 2006/006/029/291/002 Field Safety Corrective Action 2006/07/26 Abbott Laboratories Ltd.

SA060060 Olympus Life and Material Science Europa GmbH - Immunoglobulin M, OSR6146 2006/005/015/291/003 Field Safety Corrective Action 2006/07/26 Olympus Hong Kong Ltd.



SA060063 2006/007/021/081/003 Field Safety Corrective Action 2006/07/31 Roche Diagnostics (Hong Kong) Limited

SA060064 2006/007/028/291/004 Field Safety Corrective Action 2006/07/31 Beckman Coulter Hong Kong Ltd.

Abbott Laboratories Murex HTLV I + II, List Number: 8E22-02, Lot Number: J156610 and J156710 MHRA

MHRA

Cordis SV-5 and SV-8 Peripheral Steerable Guidewires Catalog 503-558, 503-558X, 503-658, 503-658X (41 specific lots only) MHRA

Baxa Ltd. Reusable enteral feeding dispenser 50ml for attachement to female oral ports MHRA

Potasium electrode for Roche Hitachi 917 Modular Analytics, Lot number L33 and L99 and all M lots MHRA

Beckman Coulter Cytomics FC 500 Flow Cytometers System with CXP Software versions: 2.0 and 2.1 MHRA



















2960 7117 35 units of the affected models previously supplied in Hong Kong.




2240 6260


2789 3300 The local agent has informed all affected users. No product recall was necessary.




























2919 1355 31 affected units in Hong Kong. Rectification completed.




2802 6333 106 units distributed in Hong Kong.


N/A









2792 7773

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