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Major Safety Alerts in October 2012

Description of Product Reference No. by Source

2012/10/03 2012/009/021/051/002

2012/10/03 2012/009/024/291/013

2012/10/03 77881

2012/10/03 Zimmer Zimmer CPT Stems (Model/Catalog no.: 00811400110, Lot no.: 61947699) 77952

2012/10/03 Zimmer A.T.S. 3000 Automatic Tourniquet System (Model or catalog no.: 60-3000-101-00) 77952

2012/10/03 Abbott Diagnostics Ltd ARCHITECT HAVAb-IgG [List no.: 6C29-20 and 6C29-25] 2012/009/021/601/003

2012/10/03 2012/009/021/181/005

2012/10/03 Hospira Inc. Sterile Empty PCA Vial and Injector [Model no.: 6021-XX] 76827

2012/10/03 Zimmer Inc. Zimmer Multipolar Bipolar Cup Liner [Model/Part no.: 00-5001-040-22; Lot no.: 61261194] 77646

2012/10/03 GE Medical Systems Discovery NM/CT 670 System - NM Gantry [Model no.: 5376204-XX] 77641

2012/10/03 77413

2012/10/03 GE Medical Systems LLC Optima XR220AMX X-Ray System (Part no.: 5555000-5, 5555000-6) 77879

2012/10/03 77945

2012/10/03 77944

2012/10/03 77950

2012/10/03 Freehand 2010 Ltd Freehand System 2012/009/025/291/010

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

Date of Issue (YYYY/MM/DD)

Source of Information*

Lima Corporate modular trial neck, lateralized, anti dx, retro sx, short (Product code: 9042.25.210; Lot no.: 11H0139) MHRA

Philips Medical Systems Mobile Detector Holder for DigitalDiagnost (Single Detector, Dual Detector, Release 3) (System codes: 712020, 712022, 712025; Model/Catalog no.: 9890 010 8390X; Lot/serial no.: 465783 / 10000407, 477362 / 11000231, 477363 / 1000212, 476015 / 11000105 and 475860 / 11000112)

MHRA

Wright Medical Technology Inc. A) Procotyl E Acetabular System - Iliac Plate Double, B) Procotyl E Acetabular System - Cranial Screw, C) Profemur XM Hip Stem - Cobalt Chrome, D) Profemur Hip Sytem - Z Revision Stem, E) Profemur Hip System - Stem Straight / Taper, F) Profemur Hip Sytem - Stem Bowed / Taper, G) Profemur Hip System - Stem Straight / Splined / Slotted, H) Profemur Hip System - Straight / Fully Coated / Plasma Sprayed, I ) Profemur Hip System - Bowed / Fully Coated / Plasma Plasma Sprayed, J) Profemur Hip System - Plasma Coated Proximal Body, K) Procotyl O Acetabular System

Health Canada

Health Canada

Health Canada

MHRA

Armstrong Medical Ltd Heated Ventilator and CPAP Breathing Circuits Manufactured Using Corrugated Tubing [Catalogue no.: AMCP- or AMHO- or AMVC17- or AMVC18-.] MHRA

Health Canada

Health Canada

Health Canada

GE Healthcare Centricity PACS System ( Software Versions: 3.1.1.1, K2022PE, K2022PF, K2033JS, K2033L, K2033LG, K2034W) Health Canada

Health Canada

Beckman Coulter Inc. AU5800 Clinical Chemistry Analyzers ( Model no.: AU5810, AU5820, AU5830, AU5840) Health Canada

GE Medical Systems SCS AW Volumeshare - Seno Advantage Software Option (Modelno.: A)5183685-X, 5183859-X, 5341143-X, 5342425-X) Health Canada

Philips Medical Systems (Cleveland) Inc A) Brilliance 6/10/16 Slice CT System - Extended Brilliance Workspace PortalB) Brilliance 40/64 Slice CT System - Extended Brilliance Workspace Portal Mode no.: A) 4550 110 02101 and B) 4550 110 02101

Health Canada

MHRA

http://www.mhra.gov.uk/home/groups/fsn/documents/fieldsafetynotice/con185621.pdf


http://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/_list/rec-ret_md-im_date_oct-dec_2012-eng.php














2012/10/03 Elekta MOSAIQ (versions below 2.41) 2012/009/024/081/010

2012/10/03 Siemens AG Mammomat Inspiration, Model no.: 10140000 77775

2012/10/03 Philips HeartStart XL Defibrillator/Monitor Battery (M3516A) 2012/009/026/291/006

2012/10/03 Philips Medical Systems Practix33plus 2012/009/026/291/024

2012/10/03 2012/009/025/601/005

2012/10/03 Philips Medical Systems DMC GMBH DigitalDiagnost (Model no.: 9890 010 8390X) 77951

2012/10/03 77638

2012/10/03 Carl Zeiss Meditec AG Carl Zeiss Meditec OPMI Vario Surgical Microscope 77643

2012/10/03 Carl Zeiss Meditec AG Carl Zeiss Meditec OPMI Lumera Surgical Microscope 77642

2012/10/03 Carestream Health Inc. Kodak Ultra-Speed Dental Film 774602012/10/04 OPTI Medical Systems, Inc. BP7561 OPTI CCA-TS B-Lac Cassette (25 per box) Z-2440-2012

2012/10/04 Z-2452-2012 and Z-2453-2012

MHRA

Health Canada

MHRA

MHRA

Siemens Healthcare Diagnostics Inc. IMMULITE®/IMMULITE® 1000 IMMULITE Osteocalcin Control Module (Model/Part no.: LONCM/10385415) MHRA

Health Canada

Carl Zeiss Meditec AG FCP WL Wireless Foot Control Panels (an accessory to the Carl Zeiss Meditec OPMI family of surgical microscopes) Health Canada

Health Canada

Health Canada

Health CanadaFDA

Hologic Hologic Fluoroscan Mini C-Arm Model with A) InSight 2 Software version: 4.0 and 4.0.1; and B) InSight-FD Software version 5.0.1 and 5.0.2 FDA











http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Event-Detail.cfm?action=detail&id=62606&w=10032012&lang=eng


Major Safety Alerts in October 2012

Alert Type by Source Local Agent

FSN N.A.

FSN Philips Electronic Hong Kong Ltd

type II

type II Zimmer Pte Ltd.

type II Zimmer Pte Ltd.

FSN

FSN N.A.

Type II Hospira Limited

Type II Zimmer Pte Ltd.

Type II

Type III

Type III

Type III Beckman Coulter Hong Kong Ltd

Type III

Type III Philips Electronic Hong Kong Ltd

FSN N.A.

Hong Kin Medical Instrument Limited

Bio-Asia Diagnostics Co Ltd., Abbott Laboratories Ltd.

GE Medical Systems Hong Kong Ltd.




FSN Elekta Ltd

Type II



FSN

Type II Philips Electronic Hong Kong Ltd

Type III Carl Zeiss Far East Co., Ltd



Type III N.A.Class II N.A.

Class II Prism Technologies Limited

Siemens Healthcare Diagnostic Limited


Major Safety Alerts in September 2012


2012/09/04 2012/008/029/081/023

2012/09/04 Micro-Tech Europe Micro-Tech oesophagus stent with the REF ST01-156.xx.xxx 2012/008/017/081/014

2012/09/04 2012/008/030/081/010

2012/09/04 2012/008/024/291/005

2012/09/04 Hospira Inc. Latex-Free Extension Set with Locking Luer “T”[List no.: 0F8989701; Lot no.: 12-030-NY] 2012/008/030/081/020

2012/09/04 2012/008/030/081/020

2012/09/04 Volcano Corporations Volcano s5/s5i1111 Family, Software Version 3.2.1 I 3.2.2 2012/008/030/081/020

2012/09/05 Roche Diagnostics Co2-For Cobas C701/702 Analyzer 76803

2012/09/05 Steris Reliance 130 and 130L Cart Washer 76135

2012/09/05 76745

2012/09/05 FCA-2012-070

2012/09/05 76881

2012/09/05 77039

2012/09/05 Vital Images Inc Vitrea Software Application 771382012/09/05 Wallac OY DELFIA Inducer, Model.: 3027-0010, Lot no.: 615442, 615809 76876

2012/09/05 Integra Burlington MA Inc A) CRW System - Intubation Head Ring Kit; B) CRW System - Lightweight Arc 77069

2012/09/07 Z-2276-2012

2012/09/10 Boston Scientific Z Flex-270 Steerable Sheath NA

2012/09/11 Horiba Medical ABX Pentra ML (Versions V8.0.x and below, and Versions V9.0.1 and V9.0.2) 2012/008/031/081/017




Medtronic, Inc The Screw Module (“Screw Caddy”) used with the ATLANTIS® Anterior Cervical Plate System and the Premier Anterior Cervical Plate SystemPart no.: 176-504, 176-503, and 1860503

MHRA

MHRA

Applied Medical Resources Corporation Vascular Catheters [Model no.: a) A44XX, b) A47XX, c) A4FXX d) IRR-XXX-XX] MHRA

Ferrosan Medical Devices A/S a) SURGIFLO Haemostatic Matrix Kit; b) SURGIFLO Haemostatic Matrix Kit with Thrombin [Product code.: MS-0010 & MS-0011] MHRA

MHRA

Siemens Healthcare Diagnostics Dimension ® Hemoglobin A1c (HB1C) Flex ® Reagent cartridges (Catalogue no.: DF105A) MHRA

MHRA

Health Canada

Health CanadaBard Access Systems Statlock Arterial Ultra Device Model no.: ART0422 Health Canada

Baxter Healthcare Corp INTERLINK System BURETROL Solution Set with 150mL Burette (Ball-Valve Drip Chamber) and CLEARLINK System BURETROL Solution Set with 150mL CLEARLINK Burette (Ball-Valve Drip Chamber)Product code no.: 2C7519 and 2C8819

Baxter Healthcare Limited

Terumo Cardiovascular Systems Corporation A) CDI Blood Parameter Monitoring System 500; B) CDI System 100 Hematocrit/Saturation Monitoring System; C) CDI 101 Blood HCT/Oxygenation Monitor Health Canada

Philips Medical Systems DMC GMBH DigitalDiagnost [Model no.: 9890-010-8390X; Lot no.: 496371; Serial no. 12000057] Health Canada

Health CanadaHealth Canada

Health Canada

Advanced Sterilization Products CIDEX OPA, High Level Disinfectant Solution, Glutaraldehyde-free (0.55% ortho-phthaladehyde) solution. [product codes: 20390 20391 20394 and 20690] FDA

Boston Scientific (Hong Kong) Ltd

MHRA








http://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/_list/rec-ret_md-im_date_july-sept_2012-eng.php


http://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/_list/rec-ret_drugs-med_july-sept_2012-eng.php






http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-2276-2012&w=09052012&lang=eng


2012/09/11 2012/009/003/081/034

2012/09/11 Hospira Inc. LifeCare PCA infusion system (List no.: 0F782) 2012/008/031/291/0012012/09/11 Bayer HealthCare GLUCOFACTS Deluxe software version 3.01 2012/009/005/601/0022012/09/11 Valisafe International Valisafe Bowie & Dick Type Test 2010/008/010/401/002

2012/09/11 Thermo Fisher Scientific Remel Xpect® Clostridium difficile Toxin A/B 2012/008/031/601/003

2012/09/11 2012/008/031/291/004

2012/09/11 Stryker Orthopeadics 6.5mm Cancellous Bone Screw 25mm and 35mm 2012/008/031/081/018

2012/09/11 2012/008/031/601/005

2012/09/11 2012/009/003/081/001

2012/09/11 Lima Orthopaedics UK Limited Lima SMR Anatomical Polythylene Liner 2012/008/020/081/008

2012/09/11 2012/009/003/081/023

2012/09/11 2012/009/004/081/008

2012/09/11 2012/009/006/601/007

2012/09/11 BrainLab M3 micro-MLC, including the permanently mounted micro-MLC used in Novalis 600N Linac 2012/009/006/081/012

2012/09/11 Fujifilm Medical Systems Wireless D-EVO with Automatic X-ray Detect (AXD) software installed 2012/009/003/081/038

2012/09/11 2012/008/023/601/004

2012/09/12 Silicone tracheostomy tubes MDA/2012/0622012/09/13 Newport Medical Instruments Inc Newport HT70 and HT70 Plus Ventilators Z-2250-2012

2012/09/13 Z-2313-2012

2012/09/13 Z-2312-2012

2012/09/13 AA-2012-014-R

2012/09/18 Beckman Coulter Inc. Unicel DXH 800 Coulter Cellular Analysis System (Model/Part no.: 629029) 77182

2012/09/18 Vital Signs Colorado Inc. General Purpose Temperature Probe 76750

2012/09/18 75336

Hospira Inc. Drum Cartridge and Venocath Catheters (List no.: 0G892 (Drum Cartridge Catheter), 0G891 (Drum Cartridge Catheter), 04614 (Venocath 14G), 04816 (Venocath 16G), 04718 (Venocath 18G Abbocath T); lot no.: all)

MHRA

MHRAMHRAMHRA

MHRA

Systagenix Wound Management INADINE® PVP-I Non Adherent Dressing (Model no.: P01491 (9.5cm x 9.5cm)) MHRA

MHRA

Siemens Diagnostics BR Assay Calibration, CA 27.29, Ref 03896216 and 02419937 and CA 15-3, Ref 01157807 and 03204829, in ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur CP systems MHRA

GE Healthcare Invasive Blood Pressure Cable__Production ID no.: a) 2016995-001, b) 2016995-002, c) 2016995-003__respective lot code: a) xxxx2010E, b) xxxx2010D, c) xxxx2010C MHRA

MHRA

PARI GmbH Power Adapter manufactured by FRIWO used in PARI SOLE N Inhalation Device Model number DT50, Type FW7405M/22, Item number 025B0250 MHRA

Siemens Healthcare Diagnostics, Inc Flex Large 4 Coil for MAGNETON Skyra, Verio, Specta and Biograph mMR ( Model no. 8625761) MHRA

Siemens IIMMULITE 2000/IMMULITE 2000 XPi Troponin I Reagent Kit (Model no.: L2KTI2 and Lot no.: 206 and above) MHRA

MHRA

MHRA

GCE Mediline O2/N2O DEMAND VALVES [Model no.: 9630320, 14090426, 14114033, K008212, MM3851, MM3863, MM3893, MM4095] MHRA

MHRAFDA

Siemens Healthcare Diagnostics, Inc Siemens ADVIA Centaur Multi-Diluent 1[Catalog. no.: 2 Pack REF 07907174 (110312) 6 Pack REF 07293184 (110313)] FDA

Capintec Inc. Capintec Captus 3000 Thyroid Uptake System [Catalog. no.: a) New systems :5430-0076, 5430-0077, 5430-0103, and 5430-0087; b) Conversion systems: 5430-0118 and 5430-0119] FDA

Terumo CVS Corporations Flow Module for Terumo Advanced Perfusion System 1 [Catalog. no.: 802018; Serial no.: 00032, 00042, 00056, 00147, 00623, 00700-00764, 00766-00820, 00823-00847]

TERUMO CHINA (H.K.) LTD.

Health Canada

Health CanadaGE Medical Systems Information Technologies, Inc. A) Dash 3000 Patient Monitor, B) Dash 5000 Patient Monitor, C) Dash 4000 Patient Monitor Model/Part no.: A) DASH3-XXXX-XXXX-XXXX, B) DASH5-XXXX-XXXX-XXXX,C) DASH4-XXXX-XXXX-XXXX

Health Canada

















http://www.mhra.gov.uk/home/groups/dts-bs/documents/medicaldevicealert/con184714.pdf







2012/09/18 74887

2012/09/18 77286

2012/09/18 Beckman Coulter Inc. UniCel DXH 800 Coulter Cellular Analysis System, PN 629029 77181

2012/09/18 Beckman Coulter Inc. UniCel DXH 800 Coulter Cellular Analysis System, PN 629029 77180

2012/09/18 Carefusion 303, Inc. Alaris PC Unit Model 8000 [Catalogue no.: 8000APM] 56581

2012/09/18 76898

2012/09/18 76986

2012/09/18 Philips Medical Systems Suresigns VS2+ Vital Signs Monitor [Catalogue no..: 863278, 863279] 77177

2012/09/18 3M Healthcare 3M Optreoz Sterilizer (Model/Catalog no.: 125-Z) 77327

2012/09/18 77324

2012/09/18 Ormco Corporation AEZ Mini Distal Cutter (Model/Catalog no.: 803-0500; Lot no.: 11M35M) 77378

2012/09/18 PDG Product Design Group Inc. Fuze (Model/Catalog no.: Fuze 20, Fuze 50; Lot no.: 52651 to 52919) 77473

2012/09/18 90793918-FA

2012/09/18 Philips Gemini System-2 Slice (Model no.: 45356 790 0891, Serial no: 103, 115, 144) 77328

2012/09/18 77179

2012/09/18 77326

2012/09/18 Capsule Technology Capsule Neuron Docking Station, Model no.: DC-NU-DS 77095

2012/09/19 Sorin Sorin S5/C5 Perfusion System (Model no.: 10-80-00, 10-85-00, 10-88-60, 10-88-00, 58-00-00) 2012/009/011/081/023

2012/09/19 Spacelabs Healthcare Spacelabs Healthcare Integrated Module Housing 2012/009/007/081/026

2012/09/19 2012/009/011/601/007

2012/09/19 OriGen Biomedical AB OriGen Syringe DMSO 2012/008/023/291/034

2012/09/19 Philips Healthcare Brilliance CT 6, 16, MX8000 v. EXP and GEMINI Dual 2012/009/007/081/002

2012/09/19 Philips Healthcare SureSigns VSi/VS2 Patient Monitors 2012/009/010/081/032

2012/09/19 2012/009/007/601/001

2012/09/19 Bausch & Lomb Posterior Fluidics Module (PFM), Stellaris PC Vision Enhancement System 2012/009/007/081/006

Elekta Business Area Software Systems, Impac Medical Systems Inc Sequencer (Versions: MOSAIQ 1.60V1 to 2.30.01) Health Canada

Instrumentation Laboratory Co A) ACL Top 500 CTS, B) ACL Top Base, Top CTS, Top 700 LAS, C) ACL Top 700, D) ACL Top 700 CTS Health Canada

Health Canada

Health Canada

Health Canada

Terumo Cardiovascular Systems Corp. A) Advanced Perfusion System 1 - Electronic Gas Blender/Analyzer; B) Advanced Perfusion System 1 - Base Unit [control knobs adjustments] Health Canada

C-K Dental Ind. Co. Ltd. Disposable Dental Needles [Catalogue no..: 27g x 30mm (0.4 x 30mm); 30g x 21mm (0.3 x 21mm); Lot no.: 110910] Health Canada

Health Canada

Health CanadaAmeriwater MRO Dialysis RO+ System (Model/Catalog no.: '00MRO120, '00MRO121, '00MROS20, '00MROS21, MRO1, MROS; serial no.: 31000 - 31079) Health Canada

Health Canada

Health Canada

Boston Scientific LeVeen Standard Needle Electrode System and LeVeen CoAccess Needle Electrode System

Boston Scientific (Hong Kong) Ltd

Health Canada

Carestream Inc A) DRX-Evolution / Premium OTC FF Wallstand; B) DRX-Evolution / Premium OTC FF Table; C) DRX-Evolution / Motorized OTC FF Wall; D) DRX-Evolution / with Motor, Fixed Wall Health Canada

Smith and Nephew Inc High Offset Neutral Modular Neck (Model no.: 71352112, Lot no.: 12FTM0019A, 12FTM0019D, 12FTM0021B) Health Canada

Health Canada

MHRA

MHRA

Thermo Fisher Scientific Oxoid Ready Poured Plate Brilliance MRSA 2 Agar, PO1210A, Lot Number 1226295 MHRA

MHRA

MHRA

MHRA

Siemens Healthcare Diagnostics Inc. MMULITE 2000/IMMULITE 2000 XPi EBV-EBNA IgG (Part no.: L2KEB2 and Lot no 215 and above MHRA

MHRA

























2012/09/19 JRI Orthopaedics Furlong HAC femoral stem 12mm 133° neck angle (Lot no.: 068548)

2012/09/19 Macopharma Whole Blood set (MacoPharma REF: 1201 123) (Model/Part no.: FQE6280LB) 2012/009/007/081/007

2012/09/19 2012/009/012/081/002

2012/09/19 2012/009/012/081/009

2012/09/19 2012/009/011/081/001

2012/09/21 Steris Corporation The SYSTEM 1E Liquid Sterilant Processing System (Model no.: P6500) Z-2335-2012

2012/09/21 Z-2255-2012 to Z-2256-2012

2012/09/25 Doctors Research Group Kryptonite Bone Cement 2012/009/020/081/011

2012/09/25 2012/008/015/401/002

2012/09/25 MAQUET Cardiopulmonary AG All type of HLS Cannulae (PAS…, PAL…, PVA…, PVL…) 2012/009/018/081/004

2012/09/25 Philips Healthcare Brilliance CT Big Bore with Software Versions 2.4.7 or 2.4.8 2012/009/019/081/020

2012/09/25 Pace Medical, Inc MICRO-PACE - 4580 2012/009/019/081/0212012/09/25 Simeon Medical Sim.LED 5000 and Sim.LED 7000 2012/007/027/081/013

2012/09/25 Smith and Nephew Inc Birmingham Hip™ Modular Heads Smith and Nephew NA

2012/09/25 2012/009/017/601/001

2012/09/25 Siemens AG MAVIG PORTEGRA 2 system (operated in conjunction with a Siemens AX system) 2012/009/020/081/006

2012/09/26 NA

2012/09/26 Beckman Coulter UniCel DxH 800 Coulter Cellular Analysis System 2012/009/005/601/003

2012/09/27 Mindray WATO EX-55 and WATO EX-65 Mr Holdings (HK) Ltd. NA

MHRA 2012/008/023/291/004

MHRA

Cerus Corporation INTERCEPT Processing Sets for Plasma [Model no.: INT3102B and INT3104B; Lot no: 12B29L61, 12C15L61, 12C29L61, 12D05L61, 12D12L61, and 12D19L61] MHRA

GE Healthcare GE Centricity RIS-i [Software Versions: 4.1.26, 4.2.3, 4.2.4, 4.2.5, 4.2.6, 4.2.7, 4.2.24, 4.2.25 and 4.2.26] MHRA

HeartSine Technologies HeartSine Samaritan PAD 300/PAD 300P AED [Serial no.: 0400000501 to 0700032917; 08A00035000 to 10A0070753; 10C00200000 to 10C002108200] MHRA

美國FDAGE Healthcare LLC Optima XR220amx and Optima XR200amx. (Part no.: 5555000-3, 5555000-4, 5555000-5, 5555000-6) 美國FDA

MHRA

IND Diagnostic Inc Urinalysis Reagent Strip, Catalogue no.: Series 900 (All parameter combinations from 900-01 to 900-11) MHRA

MHRA

MHRA

MHRAMHRA

Rocket Medical Rocket® Pleuraseal 3 Chest Drainage Bottle (produced between July 2012 and September 2012) MHRA

MHRA

Custom Medical Specialties Custom HSG Tray, Hysteroscopic Sterilization Pack, Custom Vein Tray, Custom Amnio Tray, Fox Chase Specials Pack, Abington Radiology Drainage Pack, Custom CT Biopsy Tray, HSG Tray, Custom Myelogram Tray, and Hysteroscopy Sterile Procedure Kit

FDA

MHRA

















2012/09/28 Z-2404-2012

Philips Brilliance CT 16 System (System code no.: 728246; Serial no.: 6462, 6447, 6495, 6514, 6467, 6482, 6473, 6544, 6439, 6453, 6436, 6536, 6448, 6449, 6471, 6498, 6502, 6504, 6452, 6510, 6508, 6438, 6513, 6456, 6505, 6457, 6442, 6454, 6461, 6469, 6485, 6458, 6475, 6487, 6531, 6520, 6490, 6470, 6437, 6497, 6481, 6489, 6488, 6455, 6543, 6499, 6493, 6443, 6463, 6476, 6477, 6478, 6526, 6545, 6546, 6518, 6491, 6450, 6451, 6468, 6464, 6466, 6459, 6472, 6444, 6445, 6529, 6530, 6440, 6532, 6515, 6486, 6507, 6512, 6483, 6524, 6480, 6479, 6509, 6460, 6441, 6465, 6474, 6484, 6492, 6503, 6511, 6517, 6519, 6523, 6525, 6549, 6555; Software version: 2.3.6)

FDA


Major Safety Alerts in September 2012


FSN Medtronic International Ltd

FSN N.A.

FSN

FSN

FSN Hospira Limited

FSN

FSN Prism VCN Limited

Type III

Type III Swedish Trading Co. Ltd.

Type III Senrex International Ltd.

NA Baxter Healthcare Ltd

Type II TERUMO CHINA (H.K.) LTD.


Type II N.A.Type II N.A.

Type II N.A.

Class II

NA

FSN N.A.

Long Hin Medical Limited/ Olympus Hong Kong and China

LimitedJohnson & Johnson (Hong

Kong) Ltd.


Roche Diagnostics (Hong Kong) Ltd

Johnson & Johnson (Hong Kong) Ltd.

Boston Scientific (Hong Kong Ltd)

FSN Hospira Limited

FSN Hospira LimitedFSN Bayer HealthCare Ltd FSN N.A.

FSN Thermo Fisher Scientific (HK)

FSN United Italian Corp. (HK) Ltd

FSN Stryker China Ltd

FSN

FSN

FSN N.A.

FSN N.A.

FSN

FSN

FSN BrainLAB Ltd

FSN N.A.

FSN N.A.

MDA N.A.Class I N.A.

Class II

Class II N.A.

NA TERUMO CHINA (H.K.) LTD.


Type II N.A.

Type II







Type II Elekta Ltd




Type I CareFusion Hong Kong Ltd.


Type II C-K Dental Ind. Co. Ltd.


Type III 3M Hong Kong Ltd

Type III N.A.

Type III

Type III N.A.

NA


Type II N.A.

Type II Smith & Nephew Ltd.

Type II N.A.

FSN IntegMed Limited

FSN Schmidt Bio Med Tech (H.K.)


FSN N.A.



FSN

FSN Bausch & Lomb (Hong Kong) Ltd

Young's L&S Dental Supplies Ltd--Hong Kong

Boston Scientific (Hong Kong Ltd)


FSN N.A.

FSN N.A.

FSN N.A.

FSN

FSN HTM Medico Pte Ltd

Swedish Trading Co. Ltd.

FSN Transmedic China Limited

FSN N.A.

FSN


FSN N.A.FSN N.A.

Smith and Nephew Smith & Nephew Ltd.

FSN N.A.

FSN

MedWatch, MD Recall N.A.

FSN Beckman Coulter Hong Kong Ltd

NA Mr. Holdings (HK) Ltd


第 II 級回收第 II 級回收 GE Medical Systems Hong Kong

Ltd.

Shun On Healthcare Limited/MAQUET Hong Kong

Limited


Class III Philips Electronic Hong Kong Ltd

Major Safety Alerts in August 2012


2012/08/02 Respironics Inc. (Philips). Respironics Trilogy 100, 200, and 202 Ventilators Z2024-2012

2012/08/02 Z-2038-2012

2012/08/02 Carefusion Alaris PC Unit, Model 8015 NA

2012/08/06 7283

2012/08/06 Philips Healthcare Philips EasyDiagnost (70642, 70643, 706030, 706031, and 706032) 70600068

2012/08/07 Berlin Heart EXCOR arterial cannula with graft CGRG-021 2012/007/030/081/003

2012/08/07 Depuy- a Johnson & Johnson company Orthopaedic Hip Retractors 2012/007/030/081/028

2012/08/07 Vascutek Ltd. Biplex vascular grafts and Biplex Biovalsalva Conduits (stentless and stented) 2012/007/030/291/002

2012/08/07 Stryker Orthopeadics PAR Extension Piece 2012/008/001/291/0102012/08/07 Stryker Instruments Radiofrequency (RF) Cannulae 2012/007/023/081/004

2012/08/07 DePuy Synthes Spine EXPEDIUM Offset Torque Wrench [Catalog no.: 2797-29-510] 2012/007/030/081/029

2012/08/07 GE Healthcare CARESCAPE Monitor B650 2012/007/030/081/002

2012/08/07 GE Healthcare CARESCAPE Monitor B850 2012/007/030/081/004

2012/08/07 GE Healthcare GE Centricity PACS-IW (Software Versions: 3.7.1 and later) 2012/008/001/291/008

2012/08/07 Gerati GERATI Babcock Tissue Holding Forceps, 31cm (Affected lot no.: 091103, 091107, 061206) 2012/005/022/401/009

2012/08/07 2012/008/001/601/001

2012/08/07 Siemens Healthcare Diagnostics Syngo Imaging XS, Version VA70A or higher. 2012/008/001/291/013

2012/08/07 2012/008/001/081/002

2012/08/07 2012/007/030/081/009

2012/08/08 76146




FDAGE Medical Systems OEC 9800; OEC FluoroTrak 9800 Plus; OEC 9800 Plus; OEC 9800 MD Motorized C-arm System FDA

FDA

Ethicon Endo-Surgery PROXIMATE®PPH Hemorrhoidal Circular Stapler and Accessories 33mm (Product Code PPH03) and PROXIMATE® HCS Hemorrhoidal Circular Stapler and Accessories 33mm (Product Code PPH01)


Philips Electronic Hong Kong LtdMHRA

MHRA

MHRA

MHRAMHRA

MHRA

MHRA

MHRA

MHRA

MHRA

Beckman Coulter Inc. IntraPrep Leucocytic Permeabilization Reagent(Serial no.: A07803 and Lot no.: 38 with the expiration date 29/08/2013) MHRA

MHRA

Steris Washer / disinfector (endoscope disinfection unit) model HAMO PTX, PTX+, UCX et UCX+Version software version prior to 25.3 MHRA

Stryker Osteosynthesis Teflon Tube T2 Humerus, Sterile (Model: 18060073S and lot number: K123596) MHRA

Sysmex Corporation A) XE-5000 Hematology Analyzer, B) XE-2100 Hematology Analyzer, C) XE-2100C Hematology Analyzer Model/Part no.: A) 063-7591-7, B) 983-1341-1, C) 053-2311-4

Health Canada

http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Event-Detail.cfm?action=detail&id=62393&w=08012012&


http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm314090.htm;%20http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm314019.htm
















2012/08/08 64245

2012/08/08 Biocare Medical Vina Green Chromagen Kit 72974

2012/08/08 75528

2012/08/08 76208

2012/08/08 76301

2012/08/08 76345

2012/08/08 76349

2012/08/08 Siemens AG Mobilett MIRA (Model no.: 10273100) 76350

2012/08/08 76351

2012/08/08 76353

2012/08/08 Kerr Corporation Discovery Trays (Modelno.: 15189, 16188) 76358

2012/08/08 Draeger Medical, Inc. Phototherapy Unit PT 4000 for Neonates / Infants (Model/Part no.: 2M-21700) 75530

2012/08/08 Biomatlante Eclipse Granules (model/part no: E1G010, lot no: 0309F112) 75809

2012/08/08 76041

2012/08/08 75990

2012/08/08 76148

2012/08/08 Philips Medical Systems Multidiagnost Eleva-Flat Detector-Image Detector (Model/Part no.: 0708MD02) 76150

2012/08/08 Smith & Nephew Ltd. NA

2012/08/08 73372

2012/08/08 Dectro International Apilux 2G 75989

2012/08/08 Roche Diagnostics Ltd Cobas IT 3000/5000 Software ( Model/Cat no.: 5161401001) 76163

Elekta Business Area Software Systems, Impac Medical Systems Inc Sequencer (Versions: MOSAIQ 1.30, 1.60, 2.00, 2.10, 2.20) Health Canada

Health Canada

PSC Industries Inc. DBA Olsen Medical Bayonet Forceps 8.5" Serrated 1.0 mm Tips Electosurgical / Monopolar Forceps / Reuseable Health Canada

Beckman Coulter Inc. A) UIBC Reagent (for Beckman Coulter AU5400 Immunochem System), B) UIBC Reagent (for Beckman Coulter AU2700 Immunochem System), C) UIBC Reagent (for Beckman Coulter AU Immunochem System)

Health Canada

Kerr Corporation Tytin W (Modelno.: 29949 & Affected lot no.: 1-1042) Health Canada

Beckman Coulter Inc. SYNCHRON Systems Compliment C4 ( Model no.: 988471 and Affected lot no.: M010418, M101905, M106012, M1009007, M111007) Health Canada

3M Healthcare Steri-Drape 2 Incise Drape ( Product code.: 2050 & Batch no.: 2017-03 BF) Health Canada

Health Canada

Siemens Medical Solutions USA, Inc Syngo Dynamics Server, Software Version 9.5 ( Model no.: 10091862 & Lot no.: 85162, 85182, 85183) Health Canada

Siemens Medical Solutions USA, Inc Syngo Dynamics Server, Software Version 9.5 ( Model no.: 10091862 & Lot no.: 85162, 85182, 85183) Health Canada

Health Canada

Health Canada

Health Canada

Beckman Coulter Inc. Coulter 6C Cell Control (Model/Part no.: 628027, A59925; lot no.: 2879740K, 2879750K, 2882770K, 2882560K, 2882570K, 2885180K, 2888120K, 2888130K) Health Canada

Roche Diagnostics Online DAT Amphetamines II Cobas C501, C502, and C311 (Model/Part no.: 4939425190, lot no.: 65282601) Health Canada

Siemens Healthcare Diagnostics Dimension Vista HCYS Flex Reagent Cart (Model/Part no.: K7044; lot no.: 12062MA, 12066MA) Health Canada

Health Canada

Smith & Nephew metal and PEEK suture anchors (include many from the BIORAPTOR, FOOTPRINT, HEALICOIL and TWINFIX product lines.)Prism Medical USA Stainless Steel 360760 Easy Swivel Carry Bar ( Model no: 360760 & Lot no.: Stainless Steel Version) Health Canada

Health Canada

Health Canada





















2012/08/08 Philips Medical Systems Heartstart MRX Defibrillator / Monitor ( Model no.: M3535A, M3536A) 75332

2012/08/08 75531

2012/08/08 76174

2012/08/08 75529

2012/08/08 75941

2012/08/08 76001

2012/08/08 ICU Medical A) Orbit 90 Subcutaneous Infusion Set, B) Orbit Micro Subcutaneous Infusion Set 76320

2012/08/10 N.A.

2012/08/14 2012/008/002/601/009

2012/08/14 2012/008/001/601/006

2012/08/14 Siemens Siemens syngo.plaza, all versions 2012/008/008/291/002

2012/08/14 GE Healthcare Innova 2121IQ, Innova 3131IQ Cardiovascular X-ray imaging systems 2012/008/008/081/016

2012/08/14 Hospital Beds NA

2012/08/14 BÂRRX Medical HALOFLEX Energy Generators, Model no: 1190A-115A and 1190A-230A 2012/008/009/081/014

2012/08/14 Bio-Rad Medical Diagnostics Biotestcell-P3 2012/008/007/291/0052012/08/14 Biomet El-Tapered 100 +3mm Liner 32/39, Part no.: E1-103239 2012/008/003/081/0262012/08/14 BrainLab Cranial Navigation System – Standard Cranial Reference Array 2012/008/008/081/0082012/08/14 Elekta Agility systems and Apex systems 2012/008/003/081/015

2012/08/14 Medtronic, Inc Symplicity® Catheters Model no.: RDN006 2012/008/003/081/006

2012/08/14 Orthofix Inc ISKD - Intramedullary Skeletal Kinetic Distractor (Limb Lengthener) 2012/008/007/291/001

2012/08/14 2012/008/008/081/025

2012/08/14 2012/005/022/401/018

2012/08/14 2012/008/006/081/019

2012/08/16 Stryker Spine SAS Luxor Retractor Base (Catalogue no.: 48250030 & affected lot no.: 093309) Z-2155-2012

Health Canada

Medtronic Sofamor Danek USA Inc Vertex Select Spinal System Non-Sterile Tap (Model/Part no.: 7756035, 7756040, 7756045, EX0310714, EX0911070, EX09111070B, EX1110186, X0911001)

Health Canada

Synthes (Canada) Ltd Hemostatic Bone PuttyModel no: 08.901.001.97S, 08.901.001.98S, 08.901.001.99S, 08.901.001D, VB1025.10S Health Canada

Linvatec Corporation D.B.A. ConMed Linvatec Pressft Suture Anchor with Hi-Fi Suture (Catalog no.: NP211, NP211H, NP212, NP261, NP261H, NP262) Health Canada

Nico Corporation BrainPath Sheath (Model no.: NN-8011, NN-8012 & Lot no.: 80344-TD00214) Health Canada

DePuy Orthopaedics Luster Cemented Polished Hip Stem (Model no.: 1521-80-001, 1521-80-002, 1521-80-003, 1521-80-004, 1521-80-005, 1521-80-006, 1521-80-007, 1521-80-008, 1521-80-009, 1521-80-010) Health Canada

Health Canada

Covidien DGPHP RFA High-Power single use grounding pads and Cool-tip RFA Electrode Kits (containing DGPHP RFA High-Power single use grounding pads)

Covidien Hong Kong Ltd

Siemens Healthcare Diagnostics ADVIA Centaur® HIV 1/O/2 Enhanced (EHIV) reagent kit, Ref no: 01463908 MHRA

Siemens Healthcare Diagnostics ADVIA Centaur® BNP kit, ADVIA Centaur TSH3 Ultra kit together with the ADVIA Centaur Multi-Diluent 1 MHRA

MHRA

MHRA

Health Canada

MHRA

MHRAMHRAMHRAMHRA

MHRA

MHRAGE Healthcare Optima XR220amx, Optima XR200amx, Brivo XR285amx Maintenance Service Procedure – Wheel Replacement MHRA

Invacare Robin EC-Track (ceiling hoist) – Lock Fixture of the Transit Coupling System. Item no.: 1491160-9010 and 1491160-0005 / number chapter 5.9 of the EC-Track Installation Manual MHRA

NIHON KOHDEN NIHON KOHDEN defibrillators cardiolife TEC-8300K seriesModel no.: TEC-8321K, TEC-8322K, TEC-8332K, TEC-8342K and TEC-8352K MHRA

FDA












http://www.hc-sc.gc.ca/dhp-mps/alt_formats/pdf/medeff/advisories-avis/prof/2012/hospital_bed-lit_hopital_2_nth-aah-eng.pdf











http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-2155-2012&w=08152012&

2012/08/16 Roche Molecular Systems, Inc. cobas KRAS Mutation Test (Model/Part no.: 05852170190; lot no.: PO6778) Z-2159-2012

2012/08/16

2012/08/16 GE OEC Medical Systems The FluroTrak Spinal Navigation Application on the OEC 9900 EliteNav Z-2136-2012

2012/08/17 NA

2012/08/17 Terumo AA-2012-012-R

2012/08/20 Baxter Healthcare Ltd Sterile Water for Irrigation 1000ml MDA/2012/057

2012/08/20 Varian Medical Systems Clinac, Trilogy, Novalis Tx and Unique jaw carriers CP-08881

2012/08/21 Stryker Spine Torque Wrench: XIA3 – MANTIS REDUX – SPECIALTY AUDIBLE 2012/008/010/081/013

2012/08/21 Siemens Artiste MV Syngo RT Therapist 76625

2012/08/21 Getinge Castle Modell 233 Steam Sterilizer 76462

2012/08/21 Fehling Instruments GmbH & Co. KG Sterilization containers UBD-0 and UBH-0 with quick-lock filter 2012/008/013/291/004

2012/08/21 Galil Medical FPRCH6000 – Visual-ICE® Cryoablation System [Serial no.: VL0014, VL0015, and VL0016] 2012/008/010/601/006

2012/08/21 Invacare Zimma Walking Frames [Model no: 1536700] 2012/005/009/081/016

2012/08/21 759748

2012/08/21 Oxoid Company Chromogenic ESBL Isolation Agar [Part no.: MP0430; Lot no.: 2149] 73288

2012/08/21 76278

2012/08/21 Hospira Inc. 100 mL Burette Set, Convertible Pin, 77 inch [Model no: 12722001; Lot no.: 960985H] 76431

2012/08/21 Andocor 24 fr Arterial Perfusion Cannulae, Product Code.: A24061V, Batch no.: 12-02-4222 2012/006/008/291/012

2012/08/21 Bioconnect Systems Optiflow Anastomotic Connector 2012/008/014/601/007

2012/08/21 Central Medical Supplies Kanmed Water Mattress, Part no.: TEK-BW-50-003 2012/001/019/401/004

2012/08/21 Welch Allyn Inc A) KleenSpec Single Use Vaginal Speculum; B) Speculum 76145

2012/08/21 Dominion Biologicals Ltd ELU Kit Plus Red Cell Elution System, Model no: 580073, Lot no.: ELU042 76609

2012/08/21 Siemens Dimension Vista System-Theophylline Assay, Model no: K4071, Lot no.: 12135AE, 12171BB 76624

2012/08/21 Respironics Inc. (Philips). Respironics V60 Ventilator 2012/008/015/081/026 and 76748

2012/08/21 2012/008/008/601/006

FDA

Baxter Healthcare Corp AUTOMIX High Speed Compounder System, AUTOMIX Plus High Speed Compounder System, AUTOMIX 3+3 Compounder System 115V/ 230V, AUTOMIX 3+3 Compounder with Accusource Monitoring System ( Product Code.: 2M8077, 2M8075, 2M8286, 2M8286K, 2M8287)

FDA Z-2139-2012, Z-2140-2012, Z-2141-2012, Z-2142-2012

FDA

Shanghai Shenfeng, China L-Gel Ultrasound Transmission Gel, manufactured between June 2011 and May 2012 Affected lot no.: 2011 06 17 to 2012 04 09

TGA

Terumo CVS Terumo Advanced Perfusion System 1: Interface Modules for CDI Systems & Serial Data Transfer

MHRA

Varian Medical Systems Pacific Inc.

MHRA

Health Canada

Health Canada

MHRA

MHRA

MHRAGrenier Bio One North America Inc. 3 mL 9NC Coagulation Tube 3.2% [Model no.: 454334 & Lot no.: B041206] Health Canada

Health Canada

Baxter Healthcare Corp Basic Solution Set, 1.2 Micron Filter [Model no.: JC5467; Serial no.: R11K03207, R11K03199, R11K03181, R12A20028] Health Canada

Health Canada

MHRA

MHRA

MHRA

Health Canada

Health Canada

Health Canada

MHRA and Health Canada

Siemens Healthcare Diagnostics ADVIA Centaur FSH assay on the ADVIA Centaur and ADVIA Centaur XP system, Calibrator B lot 40 and below. MHRA




http://www.tga.gov.au/safety/alerts-device-l-gel-120816.htm

http://www.mhra.gov.uk/Publications/Safetywarnings/MedicalDeviceAlerts/CON179798

















http://www.mhra.gov.uk/home/groups/fsn/documents/fieldsafetynotice/con179764.pdfhttp://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/_list/rec-ret_md-im_date_july-sept_2012-eng.php


2012/08/21 2012/008/008/601/007

2012/08/21 76401

2012/08/21 76151

2012/08/21 Terumo CVS Roller Pump Encoder Cable 74574

2012/08/21 Topcon Medical Laser Systems Wave-Front Analyzer KR-1W (Affected lot no.: 3550180) 76368

2012/08/21 Imaging Sciences International Dexis Imaging Suite, Version 10.0.0-10.0.3 Model no.: PLU817 76600

2012/08/21 75392

2012/08/23 CareFusion Alaris Pump Module, Model 8100 NA

2012/08/23 Invacare Powered Wheelchair (all chairs in the Harrier range) MDA/2012/060

2012/08/24 GE Healthcare GE Advantage Workstations Z-2203-2012

2012/08/24 CareFusion Alaris Pump Module Model 8100 (manufactured between August 2010 and July 2011) Z-2185-2012

2012/08/24 Covidien DUET™ TRS Universal Straight and Articulating Single Use Loading Units N.A.

2012/08/24 Z-2207-2012

2012/08/24 Teleflex Medical TAUT (Catalog no.: PI-128) Z-2186-20122012/08/29 Angiotech IQ Geometry Slit knives 2012/008/017/081/019

2012/08/29 DiaSys Diagnostic Systems Creatinine PAP FS, Cat. No.: 1 1759 / Creatinine FS Cat. No. 1 1711 2012/008/021/291/007

2012/08/29 2012/008/022/081/011

2012/08/29 2012/008/021/291/003

2012/08/29 Roche Diagnostics Symantec pcAnywhere software used in Total System Manager (TSM) 2012/008/022/081/012

2012/08/29 Sequana Medical AG ALFApump system 2012/008/022/081/0202012/08/29 Elekta SL75/5 2012/008/014/081/009

2012/08/29 Gen-Probe GTI Diagnostics LIFECODES PAK12G Assay Kit (Problems with Positive Control) 2012/008/020/081/007

2012/08/29 2012/008/017/291/002

Siemens Healthcare Diagnostics ADVIA Centaur Prolactin assay on the ADVIA Centaur CP system, Calibrator B lot 40 and below MHRA

Agfa Healthcare N.V. Impax Cardiovascular (CV) Reporting Style Sheet Model no.: 60+00007791, 60+00007792Affected lot number: Model L9M21000

Health Canada

Stryker Trauma AG Twist Drills with AO Fitting ( Part no.: 704005, 704005-10 and affected Lot no.: ZS131763, W37630, W38887, X05215, X05752, X11934, X18594) Health Canada

Health Canada

Health Canada

Health Canada

Beckman Coulter Inc. A) RF Latex Assay (ON AU5400)B) RF Latex Assay (ON AU2700)C) RF Latex Assay For AU Chemistry SystemsModel no.: OSR61105

Health Canada

FDA

MHRA

FDA

FDA


Philips Medical Systems Essenta DRModel no.: 712070Affected Serial no.: SN09000006/ SN09000007/ SN10000033/ SN10000014/ SN100000654/ SN08000092/ SN08000050

FDA

FDAMHRA

MHRA

Elekta Digital Accelerators from 105345 to 151675 (inclusive), fitted with X-ray Volume Imaging System (XVI) MHRA

Philips Healthcare Brilliance 6, 10, 16, 40, 64, and Brilliance CT Big Bore (Problems with Damage of Foot Switch Cover) MHRA

MHRA

MHRAMHRA

MHRA

Integra LifeSciences Corporation MAYFIELD® Left Gel Pad, MAYFIELD® Right Gel Pad [Model/ no.: 440C1011 & 440C1012. ; Lot no.: 093990 and 093984] MHRA








http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm316612.htm















2012/08/29 Solar-Med Limited Mod 496

2012/08/29 Pentron Clinical TempSpan CMT [Model no.: N69CA & Lot no.: 3534044, 3596030, 3624653, 3624656] NA

2012/08/30 Z-2240-2012

2012/08/30 Z-2257-2012 to Z-2259-2012

2012/08/30 Z2224-2012

2012/08/31 Varian Medical Systems Eclipse Treatment Planning System [Versions 8.9 and 10.0] Ref.:CP-08922 CP-08922

2012/08/31 Fake dental equipment online N.A.

Hill-Rom VersaCare® Bed (Siderail Caregiver PC Board Chip Issue) [Model no.: Revision E through J;Serial no.: H345AD5880 to N138AL9061]

Sybron Dental Specialties

GE OEC Medical Systems 892.1650 Image-intensified fluoroscopic x-ray system [Model no.: HDS721616PLAT80 ; GE Healthcare part number 5304649] FDA

Beckman Coulter Inc. A) UniCel DxI 800 Access Immunoassay Systems; B) UniCel DxI 600 Access Immunoassay Systems; C) UniCel DxC 660i, 680i, 860i, 880i SYNCHRON Access Clinical Systems; [Software anomaly]

FDA

Biomet UK Oxford Gap Gauge SML 3/4mm, Cat no.: 32-422801, Lot no.: ZB111101, ZBll1201, ZB120101, ZB120501, ZB111102, and ZB120201 FDA

Varian Medical SystemsMHRA




http://www.mhra.gov.uk/NewsCentre/Pressreleases/CON181209

Major Safety Alerts in August 2012


Class I Celki Medical Company

Class I

MedWatch, MD recall CareFusion Hong Kong Ltd.

NA

NA Philips Electronic Hong Kong Ltd


FSN

FSN Keymax Technology (HK) Ltd.

FSN Stryker China LtdFSN Stryker China Ltd

FSN

FSN

FSN

FSN

FSN N.A.


FSN

FSN Swedish Trading Co. Ltd.


Type III Sysmex Hong Kong Ltd.



Johnson & Johnson Medical (HK)






Type III Elekta Ltd

Type III Oracle Link Technology Limited

Type III N.A.


Type III Citicon (Hong Kong) Limited



Type III

Type III

Type III


Type II Draeger Medical Hong Kong Ltd.

type III N.A.

type III Beckman Coulter Hong Kong Ltd

Type III

type III


FSN Smith & Nephew Ltd.

Type II N.A.

Type II N.A.

Type II








Type II Medtronic International Ltd

Type I Synthes (Hong Kong) Ltd

Type II N.A.

Type II N.A.

Type II

Type II N.A.

NA Covidien Hong Kong Ltd

FSN

FSN

FSN

FSN

Notice to Hospitals N.A.

FSN Sky Medi-tech Ltd.

FSN N.A.FSN N.A.FSN BrainLAB LtdFSN Elekta Ltd


FSN N.A.

FSN

FSN Direct Health Ltd.

FSN N.A.

Class II Stryker China Ltd







Class III

Class I Baxter Healthcare Ltd

Class I

Alerts N.A.


MDA Baxter Healthcare Ltd

NA


Type II

Type II N.A.

FSN N.A.

FSN N.A.

FSN Direct Health Ltd.

Type I Mekim Ltd

Type II

Type II Baxter Healthcare Ltd

Type II Hospira Limited

FSN N.A.

FSN N.A.

FSN

Type III Ultronics Enterprises Ltd

Type III Uninet Technology LTD

Type III

FSN and Type II Celki Medical Company

FSN





Thermo Fisher Scientific (Hong Kong) Ltd

Associated Medical Supplies Company, Ltd.



FSN

Type II AGFA Hong Kong Limited

Type II Stryker China Ltd


Type II N.A.

Type II N.A.

Type II Beckman Coulter Hong Kong Ltd

MedWatch, MD recall CareFusion Hong Kong Ltd.

MDA Direct Health Ltd.

Class II

Class I CareFusion Hong Kong Ltd.


Class II Philips Electronic Hong Kong Ltd

Class III N.A.FSN N.A.

FSN N.A.

FSN Elekta Ltd


FSN

FSN N.A.FSN Elekta Ltd

FSN bioMerieux China Ltd.

FSN Milverton Limited




NA Solar-Med Limited

NA Citicon (Hong Kong) Limited

Class II

Class II Beckman Coulter Hong Kong Ltd

Class II N.A.

FSCA

Press Release N.A.



Major Safety Alerts in July 2012


2012/07/03 2012/006/029/081/011

2012/07/03 Terumo CVS Terumo Advanced Perfusion System 1 -Centrifugal system AA-2012-001-C

2012/07/03 Terumo CVS Terumo Advanced Perfusion System 1 - Electronic Patient Gas System AA-2012-002-C

2012/07/03 Terumo CVS Terumo Advanced Perfusion System 1 - Battery Capacity AA-2012-004-C

2012/07/03 Terumo CVS Terumo Advanced Perfusion System 1 - Roller Pump AA-2012-010-C

2012/07/03 Terumo CVS Terumo Advanced Perfusion System 1 - Central Control monitor AA-2011-020-C

2012/07/03 2012/006/011/081/014

2012/07/03 ev3 ev3 Onyx Liquid Embolic System N.A.

2012/07/03 2012/006/020/081/011

2012/07/03 2012/006/027/081/004

2012/07/03 Agfa Healthcare IMPAX 6.4 Server Software integrated with Agfa RIS, and use Enterprise Query 2012/006/027/081/002

2012/07/04 Advanced Sterilization Products STERRAD® CYCLESURE® 24 Biological Indicators N.A.

2012/07/05 BD N.A.

2012/07/06 Z-1896-2012

2012/07/06 GE OEC Medical Systems OEC Uroview 2800 (Model no.: A349855) Z-1865-2012

2012/07/09 Maquet FLOW-i Anesthesia System C20, C30 and C40 N.A.

2012/07/09 N.A.

2012/07/10 Farla Medical Ltd Minor Surgery Pack Standard 2012/007/002/291/0042012/07/10 Exactech Inc Equinoxe Shoulder System 2012/007/002/081/005




Liko (a Hill-Rom company) Likorall® 200 Ceiling Lift (production dates: Oct to Nov 2011) (Model/Part no.: 312101; Serial no: 8405801 to 8405856) MHRA






Stryker Endoscopy Formula Shaver Hand Control and Formula 180 (Catalogue no.: 0375704500E and 0375708500E) MHRA

FDA

B. Braun Avitum (UK) Ltd Hemodialyser xevonta Hi 20 [Model no.: 7204665; Batch no: 140350412] MHRA

Integra Lifesciences (Ascension Orthopedics) PyroTITAN Humeral Resurfacing Arthroplasty (CHRA) [Ref no.: CHRA-910-47/20-WW; Batch no.: 09-2119] MHRA

MHRA

FDA

BD BD PrepStain™ Diti 1.2 (Cat no.: Diti 1.2 (750-07024-00, SAP 490670) and Diti 1.2 upgrde kits (Cat no. 750-07377-02, SAP 491074)Philips Healthcare Philips HeartStart MRx monitor/defibrillators Models: M3535A, M3536A, M3536M4, M3536M5, and M3536M6 FDA

FDA

FDA

Standard Diagnostics, Inc (A) SD BIOLINE HIV Ag/Ab Combo PQDx 0069-012-00; (B) SD BIOLINE HIV-1/2 3.0 PQDx 0027-012-00; (C) SD BIOLINE Malaria Ag P.f/Pan PQDx 003 0-012-00; (D) SD BIOLINE Malaria Ag P.f PQDx 0031-012-00

WHO

MHRAMHRA



http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm310199.htm




http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm310549.htm

http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Event-Detail.cfm?action=detail&id=62333&w=07052012


http://www.fda.gov/Safety/Recalls/ucm310815.htm

http://www.who.int/diagnostics_laboratory/procurement/120626_sdbioline_noc.pdf



2012/07/10 2012/007/003/601/006

2012/07/10 Unomedical Limited UK Neria Steel Cannula infusion sets 2011/005/012/401/014

2012/07/10 2012/007/004/601/008

2012/07/10

2012/07/10 Silentia AB All products in Silentia Screen System 2012/007/003/291/012

2012/07/10 Siemens IMMULlTE/IMMULITE 1000 Third-Generation TSH (Part no.: LKTS1/5; Lot no.: 428, 431, 432) 2012/006/028/601/001

2012/07/10 Ottobock XENO stand-up chair 2012/006/022/291/021

2012/07/10 Kimberly-Clark ULTRA Fabric Reinforced Surgical Gown X-Large, Sterile (Product Code.: 95221) Kimberly-Clark N.A.

2012/07/10 2012/007/004/081/018

2012/07/11 74853

2012/07/11 DIAGNOSTICA STAGO STA Satellite (Model/Part no.: 58104) 75215

2012/07/11 Maquet Cardiovascular Paediatric Arterial Cannula (Model no.: 161412, lot no.: 92051578, 92048923) 74337

2012/07/11 Stryker Endoscopy IFU for Arthoscope and Hardware Set Tray (Part no.: 0233-032-116) 75386

2012/07/11 Varian Eclipse Treatment Planning System V8.8 (Model no.: 100042024) 75441

2012/07/11 74232

Thermo Fisher Scientific Oxid Antimicrobial Susceptiability Testing Disc FOX30 (Cefoxitin) (Model no.: CT0119B and Affected lot no.: 1186069) MHRA

MHRA

Vygon (UK) Ltd Vygon Bionector S and Aurum glass syringes Model no.: 841.233, 841235E, 841.265, 841266E, 841.365, 85222.01C, 852201F, 896.21 & 896.23 MHRA

Roche Diagnostics Symantec pcAnywhere software used in Data Station AMPLILINK, LightCycler 1.2 (CE-IVD, US-IVD)*, LightCycler 2.0 (CE-IVD, US-IVD)*, cobas® 8000 data manager (All Versions), COBAS INTEGRA® 400, COBAS INTEGRA® 400 plus

MHRA 2012/006/027/081/010

MHRA

MHRA

MHRA

Elekta Inc. IMPAC Medical Systems, Inc Monaco RFC 35238 and Focal RFC 35256 (Affected versions.: Monaco Release 3.10 and Focal Release 4.64.00) MHRA

Maquet Cardiopulmonary AG A) Perfusion Pack Bioline, B) Standard Pump Pack Bioline, C) Heart Lung Pack Bioline, D) ECLS Pack, Bioline Coated Kit, E) Custom Pack with Softline, F) Quadrox-I Adult Oxygenator with Integrated Hardshell Reservoir, G) Quadrox-I Adult Oxygenator, H) Permanent Life Support Set, I ) Small Adult Heart Lung Perfusion Pack with Softline, J) Quadrox-I Adult Oxygenator with Integrated Hardshell Reservoir (Softline), K) Quadrox-I Small Adult Oxygenator with Integrated Hardshell Reservoir (with Bioline), L) Quadrox Oxygenator with INtegrated Hardsteel Reservoir, M) Quadrox-I Pediatric Oxygenator with Integrated Hardshell Reservoir, N) Quadrox-I Neonatal Oxygenator with Integrated Hardshell Reservoir, O) Quadrox-ID Adult Oxygenator (with Bioline), P) Quadrox-ID Adult Oxygenator (with Softline)

Health Canada

Health Canada

Health Canada

Health Canada

Health Canada

Varian A) Eclipse Ocular Proton Planning V. 1.1B) RapidArc, also know as Dose Dynamic Arc / Volumetric Modulated Arc TherapyC) Eclipse Treatment Planning System V. 8.8

Health Canada















2012/07/11 75030

2012/07/11 75027

2012/07/11 Radiometer Medical APS SafePico Aspirator Kits 72340

2012/07/11 Roche Diagnostics Online DAT Amphetamines II for Cobas Integra 75330

2012/07/11 Kerr Corporation Tempspan Clear Matrix 75387

2012/07/11 GE Medical Systems AW Server 75050

2012/07/11 75334

2012/07/11 DAKO Denmark A/S Intrastain Kit 752562012/07/11 Hill-Rom Advanta 2 (P1190) 74341

2012/07/11 75266

2012/07/11 Kerr Corporation, also trading as Pentron Clinical TempSpan CMT (Model/Part no.: N69CA) 75337

2012/07/11 Sybron Dental Specialties, Inc Correct Plus Bite Superfast (Part numbers.: Q34IA, Q34IC) Firm NA

2012/07/11 Philips Gemini, Precedence, and Brilliance Firm CIL 10-012-347102 Rev 2

2012/07/11 Battlecreek Equipment Co. Thermophore Automatic Moist Heat Pack 74555

2012/07/11 74840

2012/07/11 Ellman International Inc D110FSHP and D115FSHP Reusable Handpieces 75149

2012/07/12 N.A.

2012/07/12 Z-1941-2012

2012/07/12 Philips Healthcare Philips Xcelera Connect, Software R2.1 L 1 SP2 Z-1942-2012

2012/07/13 Nobel Biocare AB NobelClinician Nobel Biocare AE11192012/07/13 Nobel Biocare AB Abutment MZ Straumann BL NC Nobel Biocare AE1220

2012/07/16 Westone Laboratories, Inc. Oto-Ease® ear lubricant N.A.

GE Medical Systems A) 3.0T Signa HDX MR System - Main Unit (P/N: M3335JK)B) 1.5 T Signa HDX MR System - Main Unit (P/N: M3335J, M3335JA, M3335JB, M3335JG)C) Discovery MR750 MR System - Main Unit (P/N: M7000MC)D) Signa HDXT 1.5T MR System - Main Unit (P/N: SIGNA HDXT 1.5T MR SYSTEM)E) Discovery MR450 1.5T MR Sytem - Main Unit (P/N: SIGNA HDXT 1.5T MR SYSTEM)F) Optima MR450W MRI System - 16CH - Main Unit (P/N: M7000WD)G) Optima MR450W MRI System - 32CH-Main Unit (P/N: M7000WE)

Health Canada

Life Technologies Corporation (Invitrogen) DPB1 SSP UniTray Kit / DPB1 SSP UniTray Kit with Taq Polymerase (P/N: 451606D, 451616D) Health Canada

Health Canada

Health Canada

Health Canada

Health Canada

TRUMPF Medical Systems iLED 5 Ligting System, Ondal AC3000, FA AC3 Spring Arm( Model no.: 1851710, 1851710) Health Canada


Bio-RAD Laboratories Liquichek Blood Gas Plus E Ctl. Niveaux 1,2,3 and Trilevel MiniPak (Model/Part no.: 576, 577, 578, 575X) Health Canada

Health Canada

Health CanadaLife Technologies Corporation (Invitrogen) A) Allset Gold SSP HLA-B Locus High Res. Kit, B) B17 SSP UniTray Kit / B Locus High Res SSP UniTray Kit Health Canada

Health Canada

Alere San Diego Alere Triage Diagnostic Tests (Multiple Tests), including Triage CardioProfiler Panel, Triage Cardiac Panel, Triage Profiler SOB Panel, Triage BNP, and Triage D-dimer FDA

Pride Mobility Products Corp Victory 9 with Power Seat (SC609PS) Motorized wheelchair with elevating seat. FDA

FDA

FDA



















2012/07/16 MDA/2012/045

2012/07/17 PENTAX PENTAX EG-3870UTK Ultrasound Video Gastroscope 2012/007/009/081/0152012/07/17 Perkin Elmer Genetic Screening Processor (GSP) 2012/005/028/401/016

2012/07/17 SuperDimension SuperDimension® Systems, AAS00016-xxx, Software Version: 4.0-4.9 2012/007/004/081/001

2012/07/17 2012/007/011/081/002

2012/07/17 Zhengzhou Tianjie Electronic Equipment Co Tianjie Dental Falcon MDA/2012/046

2012/07/17 Smith & Nephew DYONICS BONECUTTER ELECTROBLADE (4.5 and 5.5 mm) Smith & Nephew Ltd. NA

2012/07/17 NA

2012/07/17 2012/007/009/601/003

2012/07/17 Smith & Nephew Endoscopy Twinfix Ultra Ti Suture Anchor, 5.5 mm 2012/007/009/081/0042012/07/17 Stryker Osteosynthesis Telescopic Struts Hoffmann LRF 2012/007/006/291/002

2012/07/18 Covidien Shiley Reusable Cannula Cuffed Tracheostomy Tubes N.A.

2012/07/19 Carefusion EnVe Ventilator, manufactured between December 2010 and January 2012 Z-2006-2012

2012/07/19 Z-1928-2012 to Z-1932-2012

2012/07/19 GE OEC Medical Systems InstaTrak with Multiple Dataset Navigation, 892.2050 System Z-1985-2012

2012/07/19 Philips Healthcare HeartStart MRx monitor/defibrillatorss. M3536A with software versions, R.03.03 Z-1986-2012

2012/07/19 Z-1960-2012

2012/07/19 Z-1952-2012 to Z-1956-2012

2012/07/20 Sybron Dental Specialties, Inc Discovery Trays (Part no.: 16188 – child size, 16189 – small size) NA

2012/07/20 Ormco Corporation AEZ Mini Distal Cutter w/ Hold Long (Part no.: 803-0501; Lot no.: 11M36M) NA

2012/07/23 Stryker Australia Pty ABG II Modular Femoral Stem and Modular Neck TGA NA

2012/07/23 NA

2012/07/24 Getinge Lancer SA Channel separator LFC-S-05 used with Fibrocleaners, Poka Yoke, Ed FLOW 2012/007/009/081/021

Haemotronic and Bellco A) Aquarius haemofiltration machine consumables; B) BM25 haemofiltration machine consumables (All consumables are supplied by Baxter Healthcare Ltd) MHRA

MHRAMHRA

MHRA

GE Healthcare Discovery MR450, Optima MR450w (with and without GEM), Discovery MR750, Optima MR360, Brivo MR355, Signa HDx, Signa HDxt, Signa Vibrant, Signa HDi, Signa HDe 1.5T, Ovation HD, and Profile HD

MHRA

MHRA

Philips Healthcare HeartStart MRx monitor/defibrillators (All Philips HeartStart MRx monitor/defibrillators manufactured prior to June 2012 and used in external transport and Emergency Medical Service (EMS) environments.)

Philips Electronics HK Ltd.

Siemens Healthcare Diagnostics Inc. Dimension® RxL - Reagent Management System (RMS) Power Cord Plug MHRA

MHRAMHRA


FDA

Alere San Diego Alere Triage CardioProfiler Panel PN 97100CP, Alere Triage Cardiac Panel PN 97000HS, Alere Triage Profiler SOB Panel PN 97300, Alere Triage BNP PN 98000XR, Triage D-dimer PN 98100 FDA

FDA

FDA

GE Healthcare GE Advantage CT/PET Fusion for Advantage Windows Workstation with Volume View CT Colonography/Navigator 2 software, Versions: 4.0, 4.1,or 4.2 FDA

Civco Medical Instruments Inc CIVCO VirtuTRAX Instrument Navigator: (Ref. 5350925);(Ref. 610-1080)CIVCO General Purpose Sensor: (Ref. 10441627); (Ref. 610-1066); (Ref. 610-1067) FDA

Sybron Dental Specialities


PAUL HARTMANN Disposable surgical gown-- Foliodress [Comfort Basic, Comfort Perfect, Comfort Special, Protect Standard, Protect Reinforced, Protect A Standard Protect A Reinforced]

PAUL HARTMANN Asia-Pacific Ltd

MHRA

















2012/07/24 Kreatech Diagnostics FIP1L1-CHIC2-PDGFRA triple color deletion/fusion probe (KBI-10007) 2012/006/008/401/013

2012/07/24 Microtek Medical (Intuitive Surgical) da Vinci Surgical Systems [da vinci, da vinci S, da vinci Si, da vinci Si-e] 2012/007/013/081/013

2012/07/24 2012/007/017/291/004

2012/07/24 R82 A/S Mustang walking aids 2012/007/017/081/018

2012/07/24 2012/007/019/081/003

2012/07/24 EMS Medical Neonatal and paediatric endotracheal tube clamp/holder MDA/2012/049

2012/07/24 Animas Corporation Animas Insulin Pump 2012/007/013/081/020

2012/07/24 ArjoHuntleigh Pegasus® UltraLo low height electric bed frame 2010/012/021/401/004

2012/07/24 2012/007/012/081/002

2012/07/24 Biomet Orthopedics Optipac 60 Refobacin bone cement R 2012/007/019/081/0162012/07/25 bioMerieux Vidas System - EBV VCA/EA IgC 75755

2012/07/25 Philips Medical Systems Essenta Dr. Compact (Model no.: 9890 010 88201) 75781

2012/07/25 Varian Medical Systems CT/MR Ring and Tandem Applicator Set (Model no.: AL13017000) 75810

2012/07/25 65091

2012/07/25 Ortho-Clinical Diagnostics Inc. VITROS Chemistry Products DGXN Slides (Part no.: 8343386) 75644

2012/07/25 Varian Medical Systems Inc. Eclipse Version 6.5 75759

2012/07/25 75694

2012/07/25 Stryker Spine SAS Aviator Drill Bits (Catalogue no.: 48770610, 48770612, 48770614, 48770616) 75695

2012/07/25 74346

2012/07/25 Beckman Coulter Inc Coulter S-Cal Calibrator Kits 75391

2012/07/25 Beckman Coulter Inc Coulter AcT 5diff Control Plus 65922

2012/07/25 Immucor Inc PBS and Waste Container on Gallileo Echo, Model no.: 0087000 75516

2012/07/25 67568

2012/07/25 bioMerieux Inc. BACT/ALERT 3D B.40.XX Firmware [Model No.: 411814, 411815, 411818, 411925] 75277

2012/07/25 64364

MHRA

MHRA

Philips Medical Systems Brilliance series 6, 16, 40, 64, CT Big Bore, iCT, and iCT SP (Problems with J-Bracket Bolts) MHRA

MHRAWright Medical Technology Inc. Profemur TL, Profemur tapered, Profemur Z and Profemur Z plasma Packaged before February 2008 MHRA

MHRA

MHRA

MHRA

ConforMIS iTotal CR Tibial Poly Inserts (M57250600010 – iTotal CR, Left Knee, and M57250600020 – iTotal CR, Right Knee) MHRA

MHRAHealth Canada

Health Canada

Health Canada

Immucor Inc. Gamma-Clone Anti-LE B Blood Grouping Reagent ( 0004864 and affected lot no.: 992006) Health Canada

Health Canada

Health Canada

Howmedica Osteonics Corporation A) Rejuvenate Modular Neck, 0 DEGB) Rejuvenate Modular Neck, 8 DEGC) Rejuvenate Modular Neck, 16 DEGD) Rejuvenate SPT Modular Stem, Straight Press-Fit Texture TMFZ

Health Canada

Health Canada

Beckman Coulter Inc A) Avanti J26XP Centrifuge; B) Avanti J26XPI Centrifuge; C) Avanti J-HC Centrifuge; D) Optima L Centrifuge; E) Optima LXP Centrifuge; F) Optima Max-XP Centrifuge; G) Avanti J30-I Centrifuge

Health Canada

Health Canada

Health Canada

Health CanadaSierra Scientific Instruments LLC, a Given Imaging Company A) MSS-2155 Manoshield EG; B) MSS-3599 Manoshield AR; C) MSS-4360 Manoshield SD Health Canada

Health Canada

SCC Soft Computer SoftBank II v.23.0, 23.1, 23.2, 25.0, 25.1 [Used with Softscape GUI V. 1.2.0.7 to 1.2.0.15 & V. 1.3.0.4 to 1.3.0.5] Health Canada


























2012/07/25 67641

2012/07/25 74224

2012/07/25 Health Canada 75029

2012/07/25 64815

2012/07/25 Kerr Corporation TempBond NE 75913

2012/07/25 Atricure Inc. Atricure Cryo Module (Model/Part no.: ACM1; Affected lot no.: 37559-01) 75938

2012/07/26 LMA North America Inc LMA Esophageal Intubation Detector (EID100) Z-2022-2012

2012/07/26 Z-2025-2012 to Z-2027-2012

2012/07/26 Gulf Medical Fiberoptics, Inc. GMF-RC65 Replacement Surgical Headlight Cable for Cogent Micro-link Z-2029-2012

2012/07/26 Varian Medical Systems Inc. Eclipse Treatment Planning System H48 Z-2041-2012

2012/07/26 Z-2023-2012

2012/07/26 Z-2011-2012

2012/07/26 Z-2020-2012, Z-2021-2012

2012/07/26 Z-2009-2012, Z-2010-2012

2012/07/26 Spacelabs Medical, Inc. XPREZZON Bedside Monitor_91393 Z-2019-2012

2012/07/26 Z-1993-2012

2012/07/26 Sigma SIGMA Spectrum Infusion Pump Master Drug Library (MDL) Editor software (all versions) Z-2030-2012

2012/07/31 Medicrea International Anti-rotation IMPIX TLIF holder Model no.: A15130016 2012/007/025/081/008

2012/07/31 2012/007/026/291/001

2012/07/31 2012/007/024/081/014

Fisher and Paykel Healthcare Ltd. A) Auto Icon ICONAAN [Lot no.: 101101 to 110517]; B) Premo Icon ICONPBN [Lot no.: 100630 to 110511] Health Canada

Varian Medical Systems Inc. A) Aria Practice Management - 4D Integrated Treatment Console [V8.1.2, V8.6, V8.8]; B) Truebeam (Radiotherapy Configuration) - Main Unit [H191044, H191069, H191071, H191038, H191074]

Health Canada

Siemens Healthcare Diagnostics Inc. Vista Vancomycin Vanc Flex Reagent (Model/Part no.: K4086; Affected lot no.: 12095AD)Helix Medical LLC. Also trading as Inhealth Technologies Adjustable Tracheostoma Kits (Model/Part no.: BE8024H, Affected lot no.: 967741, 975155, 979331) Health Canada

Health Canada

Health Canada

FDA

GE OEC Medical Systems A)OEC 9900 Elite, OEC 9900 Elite MD Motorized C-arm SystemB) OEC 9800, OEC FluoroTrak 9800 Plus, OEC 9800 Plus, OEC 9800 MD Motorized C-arm SystemC) OEC 8800 Flexiview FDA

FDA

FDA

EKOS Corporation EkoSonic MACH4 Endovascular Device (Catalog #500-55106, 500-55112; 500-55118; 500-55124; 500-55130; 500-55140; 500-55150; 500-54106; 500-56130; 500-56140; 500-56150) FDA

Stingray Surgical Products, LLC Bipolar Forceps model number: S02-XXX, S03-XXX, P02-XXX, and P03-XXX. "Instructions For Use" (QF7.5.1A.R01 thru QF7.5.1A.R06 Care and Handling of Bipolar Forceps. FDA

Terumo CVS Terumo Advanced Perfusion System 1, System 1 Base 100/120V and System 1 Base, 220/240V (Red X error message indicating a loss or fluctuation of internal power on one side of the system's base)

FDA

Terumo CVS Terumo Advanced Perfusion System 1, System 1 Base 100/120V and System 1 Base, 220/240V (communications or power failures) FDA

FDA

GE Healthcare LLC Optima Mobile X-ray System (Optima XR200 15kw, Optima XR 200 30kw, Optima XR 220 15kw, Optima XR 220 30kw) FDA

FDA

MHRAMolnlycke Health Care Barrier Extremity Drape 230x315cmProduct code: 60213-00 and batch no.: 12167258 MHRA

Philips Healthcare Inc DigitalDiagnost, Essenta DR, Essenta DR compact, BuckyDiagnost, EasyDiagnost Eleva and TraumaDiagnost using the 5-Field Amplimat chamberSerial no.: 11320067 to 11321695 and from 11322000 to 11322231

MHRA




















2012/07/31 2012/003/028/081/007

2012/07/31 2011/010/011/401/001

2012/07/31 Diamesco Co. Ltd. Pendiq Digital Insulin Pen (Software Version 1.07.0) 2012/007/018/081/005

2012/07/31 2012/002/022/401/014

2012/07/31 Elekta Inc. Digital Accelerator [Model no.:105071 to 105360] 2012/007/020/081/016

Agfa HealthCare DRYSTAR DT2 MAMMO – REF: ERE5C and ERE6E; DRYSTAR DT5.000I MAMMO – REF: EZ5J1 (LOT : 36130026 and 36130028) MHRA

Changzhou Zhiye Medical Devices Institute (supplied in UK by L.IN.C Medical Systems) Pre-filled syringes of saline (LMPFSS) MHRA

MHRA

Flexicare Medical Flexi- Lock Catheter Mount with Double Swivel Elbow and Elastometric Cap [Part no.: 038-61-316 & lot no.: 110760229] MHRA

MHRA






Major Safety Alerts in July 2012


FSN N.A.







N.A. Sinomed Company Ltd.

FSN United Base (HK) Ltd

FSN N.A.

FSN AGFA Hong Kong Limited

Safety Communication

BD BD


Class II

Class I MAQUET Hong Kong Limited

Bio-Asia

FSN N.A.FSN N.A.








Complaints and Product Alerts


FSN N.A.

FSN N.A.

FSN

FSN Viking Group (HK) Ltd

FSN

FSN N.A.

Kimberly-Clark Shun On Healthcare Limited

FSN Elekta Ltd

Type II MAQUET Hong Kong Limited

Type II Healthpro

Type II


Type II

Type II



Shun On Healthcare Limited/MAQUET Hong Kong

Limited



Type II

Type II Invitrogen Hong Kong Limited

Type III Radiometer China (RCHN)

Type III


Type III

Type III

Type III Gene Company Ltd.Type II Solar-Med Limited

Type II Bio-Rad Pacific Ltd.

Type II N.A.

Citicon (HK) Ltd

Type II N.A.

Type II Invitrogen Hong Kong Limited

Type II N.A.

Class I N.A.

Class II N.A.


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

Firm Press Release N.A.




InnoTech Medical Trading, Marty Tang


Philips Electronics Hong Kong Ltd


MDA Baxter Healthcare Ltd

FSN N.A.FSN N.A.

FSN N.A.

FSN

MDA

class II Smith & Nephew Ltd.


FSN

FSN Smith & Nephew Ltd.FSN Stryker China Ltd

FSN Covidien Hong Kong Ltd

Class I CareFusion Hong Kong Ltd.

Class I N.A.

Class I


Class II

Class II The Vita Company Ltd.

FSN Citicon (HK) Ltd

FSCA


FSCA

FSN N.A.


Zhengzhou Tianjie Electronic Equipment Co




Young's L&S Dental Supplies Ltd--Hong Kong

PAUL HARTMANN Asia-Pacific Ltd

FSN N.A.

FSN Chindex


FSN N.A.

FSN

MDA N.A.

FSN

FSN Arjo Huntleigh (Hong Kong) Ltd.

FSN N.A.

FSN N.A.Type II bioMerieux China Ltd.


Type II

Type II Uninet Technology LTD

Type II Ortho Clinical Diagnostics

Type II

Type II N.A.






Type II

Type II bioMerieux China Ltd.

Type II N.A.





Given Imaging (Asia) Company Ltd.

Type II

Type II

type III

type III N.A.


type III N.A.

Class II N.A.

Class II

Class II N.A.

Class II

Class II N.A.

Class II N.A.

Class II TERUMO CHINA (H.K.) LTD.


class II

Class II

class III

FSN N.A.

FSN N.A.


Fisher & Paykel Healthcare Limited





MT Chu Spacelab (Mr Roger Moldon)


Baxter Healthcare Ltd. (Hong Kong)


FSN N.A.

FSN Twobiens Co., Ltd (Korea)

FSN

FSN Elekta Ltd

Flexicare Medical China Limited - China

Major Safety Alerts in June 2012


2012/06/01 73643

2012/06/01 73645

2012/06/01 73642

2012/06/01 Nidek Medical Products Inc. Nidek Medical oxygen concentrator (Various Models) FDA N.A.

2012/06/01 Alere San Diego Triage Tropinin I Test Catalogue Number 98600EU 74009

2012/06/01 Philips Medical Systems (CLE) Inc. Brilliance iCT and iCT SP 740872012/06/01 Immucor Inc. Capture-R Ready Indicator Red Cells 74104

2012/06/01 Beckman Coulter Inc. SYNCHRON® System LX Calibrator 1 62306

2012/06/01 Ortho-Clinical Diagnostics Inc. Vitros 5600 Integrated System - Software Version 1.6 and below 73912

2012/06/01 Roche Diagnostics GMBH AMPLINK Software 73974

2012/06/01 74020

2012/06/01 Stryker Instruments IFU for Neptune Waste Management System 74172

2012/06/01 73958

2012/06/01 Beckman Coulter Inc. Access Testosterone - Unicel DXC 600i Synchron Access Clinical Systems 73959

2012/06/01 Beckman Coulter Inc. Unicel DXH Slidemaker Stainer Coulter Cellular Analysis System 74006




Beckman Coulter Inc. A) Beckman Coulter AU2700 Immunochemistry system - Bicarbonate (CO2) Assay; B) Beckman Coulter AU5400 Immunochemistry system - Bicarbonate (CO2) Assay; C) Beckman Coulter AU Immunochemistry system - Bicarbonate (CO2) Assay

Health Canada

Beckman Coulter Inc. A) Access Intrinsic Factor AB (for Unicel DXI 600 Access Immunoassay System); B) Access Intrinsic Factor AB (for Access Immunoassay System); C) Access Intrinsic Factor AB (for Unicel DXI 800 Access Immunoassay system)

Health Canada

GE Medical Systems SCS A) AW Volumeshare 2; B) Advantage Workstation 4.2; C) AW Volumshare 4; D) AW Volumeshare 4 Health Canada

Health Canada


Health Canada

Health Canada

Health Canada

Varian Medical Systems A) Clinac Linear Accelerator B) Clinac IX High Energy Linear AcceleratorC) Trilogy High Energy Linear AcceleratorD) Novalis TX High Energy Linear AcceleratorE) Clinac 2100C High Energy Linear AcceleratorF) Clinac 21EX High Energy Linear AcceleratorG) Clinac 23EX High Energy Linear Accelerator

Health Canada

Health CanadaBeckman Coulter Inc. A) Navios Flow Cytometer (Navios 6 Colours / 2 Lasers)B) Navios Flow Cytometer (Navios 8 Colours / 2 Lasers)C) Navios Flow Cytometer (Navios 10 Colours / 3 Lasers) 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_2012-eng.php














2012/06/01 73679

2012/06/01 Bomimed Inc. Metal Led Disposable Conventional Blade 73918

2012/06/01 Varian Medical Systems, Inc. Eclipse Treatment Planning Sustem V8.8 EBP issues (Model No. 100042024) 73919

2012/06/01 Varian Medical Systems, Inc. Varian Treatment For Multivendor Linacs (Model No.100042022) 73925

2012/06/01 Varian Medical Systems, Inc. Eclipse Treatment Planning Sustem V8.8 (Model No. 100042024) 73926

2012/06/01 Lightlab Imaging Inc. C7 Dragonfly Imaging Catheter (Model No. 100-100-00) 73301

2012/06/01 73513

2012/06/01 Amvex Corporation Click Style Gas Regulators (Model No.: GR(X)X-YYY(Z)(W)-(X)(Y)(Z)(W)) 73640

2012/06/01 Beckman Coulter Inc Direct Bilirubin_OSR6111, OSR211, OSR6511 (all lot number affected) 73644

2012/06/01 73295

2012/06/01 73463

2012/06/01 73639

2012/06/01 73678

2012/06/01 Applied Medical Resources Corporation Surgical Clamp Inserts_G-8655_1131182 66075

2012/06/01 73374

2012/06/01 Pulse Scientific Inc. Rheumatoid Factor (RF) Latex Test (Model/Part no.: 10502, 10503) 73646

Howmedica Osteonics Corporation A) Rejuvenate Modular Neck, 0 DEGB) Rejuvenate Modular Neck, 8 DEGC) Rejuvenate Modular Neck, 16 DEGD) Rejuvenate SPT Modular Stem, Straight Press-Fit Texture TMFZ

Health Canada

Health Canada

Health Canada

Health Canada

Health Canada

Health Canada

Linvatec Corporation DBA Conmed Linvatec 8.0 MM and 8.5 MM Sentinel Drill Bit (Model No.: S8580, S8585) Health Canada

Health Canada

Health Canada

Lightlab Imaging Inc. A) CX-XR Imaging System, B) CX-XR Imaging System (Model/Part no.: A) 900-700-10, B) 900-700-00) Health Canada

Cardinal Health A) Custom Sterile Knee Pack, B) Custom Sterile Vascular/Thoracotomy Pack, C) Custom Sterile Neurology Pack, D) Custom Sterile Abdominal Hysterectomy Pack, E) Custom Sterile Pacemaker, F) Orthopaedic Pack, G) General Sterile Pack, H) Custom Sterile Extremity Pack, I ) Knee Packs, J) Urology Packs, K) Thoracotomy Pack, L) Custom Sterile Craniotomy Pack, M) Custom Sterile Head and Neck Pack, N) Custom Sterile Dental Pack, O) Custom Sterile Ear Pack, P) Custom Sterile Oral Pack, Q) Custom Sterile Throat / Tonsil Pack, R) Custom Sterile General ENT Packs, S) Custom Sterile Shoulder Pack, T) Custom Sterile General Gyne Pack, U) Custom Sterile Laparotomy / Laparoscopy Packs, V) Custom Sterile Labour and Delivery Pack, W) Laparotomy / Laparoscopy Packs, X) Facial Surgery Packs, Y) General Plastic Surgery Packs, Z) Minor Surgery Packs, AA) Major Surgery Packs, BB) Custom Sterile Abdominal Lithotomy Pack, CC) Sterile Shoulder Arthroscopy Pack, DD) Sterile Total Hip Pack, EE) Sterile ACL Pack, FF) EP Pack, GG) AV Fistula Graft, HH) Ortho Extremity Pack, II ) Craniofacial Pack,

Health Canada

Steris Corporation A) System 1 Express – Tray, B) System 1 Plus Tray (Model/Part no.: A) C1XXXINT, B) C1XXXINT) Health Canada

Osteotech Inc. A) Grafton Gel, Putty and Flex; B) Grafton DBM Putty, Gel, Flex, A-Flex, Crunch, Matrix PLF, Matrix Strips, Orthoblend, Grafton Plus DBM Paste Health Canada

Health Canada

Steris Mexico A) Evolution Transfer Carriage - AMSCO EVOLUTION PREVACUUM STEAM STERILIZER; B) Evolution Transfer Carriage - AMSCO EVOLUTION SFPP STEAM STERILIZER Health Canada

Health Canada

















2012/06/01 Wright Medical Technology Inc. Valor Targeting Guide (4150KIT1) 73728

2012/06/01 Immucor Inc. Galileo Echo Blood Bank Analyzer Cat No.: 87000 73948

2012/06/01 Abbott Laboratories Ltd N.A.

2012/06/07 Sewoon Medical Co., Ltd. Fluido Junior Disposable Sets & Fluido Junior 2012/002/010/081/010

2012/06/07 Smith & Nephew Orthopaedics Ltd Metal Liner Components of the R3 Acetabular system 2012/006/006/291/023

2012/06/07 Thermofisher Scientific MULTIGENT Hemoglobin A1c Reagent 2012/005/025/081/019

2012/06/07 BD Preset™ Arterial Blood Collection Syringe BD N.A.2012/06/07 Perouse Medical Flamingo inflation device 2012/005/025/081/0012012/06/07 Anaesthetic machines and associated devices MDA/2012/0312012/06/07 Anetic Aid Ltd 6 Use Tourniquet Cuffs (Batch no.: 15435) 2012/005/004/401/0052012/06/07 Aspen Medical Europe Ltd Procedure Kit [1672, 1674, 1650] 2012/005/029/601/003

2012/06/07 Hitachi Medical Systems Echelon OASIS AIRIS Vento AIRIS Vento LT APERTO Eterna APERTO Lucent 2012/005/029/081/004

2012/06/08 Z-1659-2012 to Z-1672-2012

2012/06/08 Z-1686-2012 & Z-1687-2012

2012/06/08 Invacare Corporation Knee walker Z-1704-2012

2012/06/08 Kerr Corporation Extrude Wash (Model no: 28418 – 2pk, 28419 – 32pk, 29036 – Value Pack) Synbron NA

2012/06/11 Trinity Biotech CaptiaTM Varicella-Zoster Virus (VZV) IgG Kit NA

2012/06/12 Waters Corporation Waters Masstrak Immunosuppressants Kit (Part Number: 186002891, Lot.: 0709) 2012/005/029/081/001

2012/06/12 2012/005/029/081/036

2012/06/12 2012/006/006/291/027

2012/06/12 Philips Healthcare DigitalDiagnost with Software Update 2.1.3 for 2.0.2 systems including mirror icon 2012/006/006/291/072

2012/06/12 2012/006/001/601/004

2012/06/12 2012/006/007/291/072

Health Canada

Health CanadaAbbott Laboratories

Ltd.MHRA

MHRA

MHRA

MHRAMHRAMHRAMHRA

MHRA

MOOG Non-DEHP Microbore or Admin Sets, Epidural Admin Sets (Model no: 340-4114, 340-4115, 340-4126, 340-4128, 340-4128-V, 340-4130, 340-4130-V, 340-4137, 340-4144, 340-4165, 340-4166, 340-4173, 340-4133, 340-4176)

FDA

Siemens Medical Solutions USA, Inc Symbia E Series SPECT System [Material number 10275879]; e.cam Emission Computed Tomography Systems [Material number 10151532]; FDA

FDA

Tin Hang Technology Limited

MHRA

Waters Corporation MassTrakTM Immunosuppressants Kit (Part Number: 186002891, 186004534 and 1860045331VD, all lots) MHRA

NEWDEAL SAS Drilling guide for diameter 3.5 mm screwInstruments included in the following Newdeal instrumentation sets: TIBIAXYS® Ankle Arthrodesis Plating System TIBIAXYS® Distal Tibia and Fibula Osteotomy Plating Systems ADVANSYS® Dorsal Lisfranc Plate / ADVANSYS® Medial Lisfranc Plate

MHRA

MHRA

Siemens Healthcare Diagnostics IMMULlTE/IMMULITE 1000 Total T3Model/Part no.: LKT31, LKT35 MHRA

ArjoHuntleigh All models Minstrel, Minerva, Excelsior, Gemini patient lifts. Manufactured by Medibo Medical Products NV MHRA











http://www.fda.gov/Safety/Recalls/EnforcementReports/ucm307229.htm









2012/06/12 Ethicon Endo-Surgery Ligaclip Extra ligating clip cartridges (Product Code: LT300) NA

2012/06/12 Covidien Monoject TM Insulin Safety Syringe 2012/005/031/081/001

2012/06/12 Cordis Coporation CordisTM Fire Star Rx PTCA Dilation Catheter_8012020D_15437344 NA

2012/06/15 Roche Diagnostics GmbH Various tests with Cobas C701 Analyzer, Hitachi Cobas C Analyzers 74429

2012/06/15 Vital Diagnostics ESR Altitude Vacuum Tubes 69956

2012/06/15 74461

2012/06/15 74465

2012/06/15 Varian Medical Systems Inc. Aria Software Vision (version 6.5) 74474

2012/06/15 74290

2012/06/15 Medinol Ltd Digital Diagnost 74401

2012/06/15 Kerr Corporation Permlastic 73960

2012/06/15 Radiometer Medical APS Calibration 1 Gas for ABL7xx / 8xx Analyzers (Model: 962-174, lot no.: C15B21) 73729

2012/06/15 74348

2012/06/15 74350

2012/06/15 66864

2012/06/15 74493

2012/06/18 Fake Thermometers N.A.2012/06/19 Waters Corporation Waters Masstrak Immunosuppressants XE RUO Kit 2012/005/029/081/002

2012/06/19 2012/006/007/291/069

2012/06/19 2012/006/007/601/004

2012/06/19 Sysmex Europe GmbH CS-2x00i Software Version 60 (V00-60) 2012/005/018/081/009

2012/06/19 Arcadia Medical Corporation Arcadia Medical Silicone Tracheostomy Tubes (all models, all types) 2012/006/007/601/003

2012/06/19 Alba Bioscience ALBAclone Anti-P1 blood grouping reagent, Product code: Z202, Lot: V112715 2012/006/006/601/005


MHRA


Health Canada

Health Canada

Varian Medical Systems Inc. A) Aria Practice Management - 4D Integrated Treatment Console (4DITC) Version 8.8 ; B) Barcode Conical Collimator Verification (BCCV) Health Canada

Varian Medical Systems Inc. Multileaf Collimator (Model: Millenium 80, MLC 52; Lot: H542182, H520320, H542533) Health Canada

Health Canada

Terumo Cardiovascular Systems Corp. A) Sarns Flexible Arterial Cannula, B) Sarns High Flow Aortic Arch Cannula Health Canada

Health Canada

Health Canada

Health Canada

Beckman Coulter Inc. Blood Bag Cup used in Model J6 Series Centrifuges (J6-HC, J6-MC, and J6-MI), Model: 363651 Health Canada

Beckman Coulter Inc. Immage Immunochemistry Systems Alpha1-Antitrypsin (AAT) Reagent, (Model: 447740, lot no.: M008203, M010527, M105003) Health Canada

One Lambda Inc. Micro SSP Allele Specific HLA Class II DNA Typing Tray - DRB1*12 (Model.: SSPR2-112, Lot no.: 005) Health Canada

Excelsior Medical Corporation A) Heparin Lock Flush (Model: 50031-1000, 50051-1000, 513604, 60031-1000, 60051-1000, E0400-35)B) Heparein Lock Flush in Syringe (Model: 0300 31-240)

Health Canada

MHRAMHRA

Stryker Orthopaedics Alumina Femoral Ceramic Head- V40 Taper +0.0mm (Model.: 6565-0-128 and lot no.: 35205901, 35205902, 35226701, 35226801, 35226801, 35544901) MHRA

Synergy Health (UK) Ltd Detex X-Ray Detectable Tied 5 Gauze Swab BP(Model: a)28925(30x30 12Ply Taped), b)28925 (30x30 12 Ply no Tape) and lot no.: a)289381312, b)289251312) MHRA

MHRA

MHRA

MHRA















http://www.mhra.gov.uk/NewsCentre/Pressreleases/CON155710







2012/06/19 2012/006/012/081/004

2012/06/19 CareFusion Airlife® Infant breathing circuits [Model no.: 6800-503 and RT 4851-12] 2012/006/011/081/024

2012/06/19 2012/006/006/291/003

2012/06/19 2012/006/008/291/023

2012/06/19 Mindray V Series Monitor (Model: V12 & V21) 2012/006/008/291/030

2012/06/19 2012/006/007/291/045

2012/06/19 2012/006/014/081/021

2012/06/19 Philips Healthcare IntelliSpace Portal (ISP)_Software versions: v4.0 or v4.0.1 2012/006/011/291/006

2012/06/19 2012/006/008/601/005

2012/06/21 Z-1788-2012 to Z-1790-2012

2012/06/21 Z-1795-2012 & Z-1796-2012

2012/06/21 Stryker Instruments A) T5 Hytrel Zipper Toga; B) T4 Hytrel Zipper Toga [Various lots] Z-1809-2012 & Z-1810-2012

2012/06/22

2012/06/22 Brainlab Brainlab iPlan RT Dose version 4.1 (v.4.1.0, 4.1.1 and 4.1.2) Brainlab Ltd 12-04-17.FRM.22012/06/26 Sekisui Diagnostics Multigent Acetaminophen Assay 750882012/06/26 Conmed Altrus Thermal Tissue Fusion Energy Source 739802012/06/26 Winco Winco Carecliners 741742012/06/26 Abbott Diagnostics Ltd Multigent - Aeroset/C8000 Hemoglobin A1C Kit 74545

2012/06/26 Sybron Dental Specialities AlgiNot Cartridge, AlgiNot Cartridge FS, AlgiNot Volume, AlgiNot Volume FS N.A.

2012/06/26 Biomerieux BV Bact/Alert MB Blood Culture Bottle 74178

2012/06/26 75025

2012/06/26 Boston Scientific Zoom Latitude Programmer/Recorder/Monitor-3120 713082012/06/26 Invacare Corporation Power Wheelchair 75032

2012/06/26 75028

2012/06/26 74938

2012/06/26 Asahi Kasei Medical Blood Purification Equipment PlasautoΣ 2012/006/018/081/005

Biomet Merck Alumina Femoral Heads (Ref no.: P0209C28, P0209C32, P0209L28, P0209L32, P0209M28, P0209M32; Affected lot no.: 2521085, 2522540, 2521086, 2557191, 2521087, 2532348) MHRA

MHRA

Mercado Medic AB Real 9000, Real 9300, Real 9700, Real 9000 Plus Manuel Vuxen, Real 9300 Plus Manuell Barn, Real 9700 Plus Coxit MHRA

Microbiologics Inc KWIK-QC Gram Stain Slides, SL03-10 SL03-10 [lot no.: 0353,0354,0355,0357,0358,0359,0360,0361,0362,0363] MHRA

MHRA

Newdeal (Integra) HINTEGRA® tibial alignment rod ref. 309615 [ lot no.: EC13 - EDD0/1 - EDD0/2 - EDD0/3 - EG6L – ELKG - ENZ0 - ELNS] MHRA

Terumo Cardiovascular Systems Corp. A) Sarns Flexible Arterial Cannula, B) Sarns High Flow Aortic Arch Cannula MHRA

MHRA

Siemens Healthcare Diagnostics Stratus CS Acute Care™ D-Dimer CalPak Calibrator (CDDMR-C)_Affected lot no.: 502058002 and 501318002 MHRA

GE Medical Systems Revolution XR/d Model numbers: 2259988-2 & 2351505, Definium 8000 Model Number: 5131070, Proteus XR/a Model Number: 2259988 FDA

Integra Lifesciences Corporation A) Integra Mozaik Strip 10 cc [Part Number 7701513001]; B) Integra Mozaik Putty 2.5cc, 5 cc, 10 cc [Part Number 7700713001] FDA

FDA

Terumo CVS A) Terumo Advanced Perfusion System 1 B) Sarns™ Modular Perfusion System 8000, C) Sarns™ Modular Perfusion System 9000


A) AA-2012-003-C-Sys1 B) AA-2012-003-C-8000 C) AA-2012-003-C-9000

Health CanadaHealth CanadaHealth CanadaHealth CanadaSybron Dental

SpecialitiesHealth Canada

GEOhmeda Medical, a Division of Datex Ohmeda Inc A) Giraffe Warmer T-Piece Resuscitation Circuits, B) Panda Warmer T-Piece Resuscitation Circuits

Health Canada


Philips Medical Systems A) Multidoagnost Eleva-Image Intensifier-TV Image Detector, B) Multidiagnost Eleva-Flat Detector-Image Detector Model/Part no.: A) 0708MD02, B) 0708MD02

Health Canada

Stryker Medical A) Go Bed Plus FL25E, B) Go Bed II, C) Go Bed Plus FL20E Model/Part no.: A) FL25E, B) FL14E3, FL28C, FL28EEX, C) FL20E Health Canada

MHRA
























2012/06/26 Carestream Health CARESTREAM DRX-1 System Batteries manufactured before June 2012 2012/006/021/081/009

2012/06/26 DiaMed/ BioRad Techno TwinStation, Product ref.: 009895 2012/006/021/081/014

2012/06/26 2012/002/008/081/025

2012/06/26 2012/006/015/081/022

2012/06/26 Teleflex Medical ConchaTherm Neptune Heated Humidifiers (Product codes: 425-00, 425-10, 425-30) 2012/006/019/291/001

2012/06/26 Transysteme AES Ankle prosthesis 2011/012/021/291/018

2012/06/26 Kerr Corporation Alginot FS Volume Refill Kit (Model/Part no.: 34683, 34682; Affected lot number: 1‐1017) 72943

2012/06/26 St. Jude Medical Merlin@Home Transmitter 74553

2012/06/27 Sunquest Information Systems Sunquest Laboratory 75100

2012/06/27 75048

2012/06/27 GE Medical Systems LLC Discovery CT750 HD (Model no.: 5212920-X) 74848

2012/06/27 73890

2012/06/27 Gen-Probe GTI Diagnostics Lifecodes Pak Plus 022811PPB 73292

2012/06/27 International Technidyne Corporation ProTime Microcoagulation System- Protimepro V-71458 74886

2012/06/27 Ormco Corporation, also trading as Sybronendo K-Flex Files 74286

2012/06/27 74549

2012/06/27 GE Medical Systems LLC Discovery CT 750 HD (Model: 5212920-X) 74849

2012/06/27 Covidien A) Kangaroo 324 Enternal Feeding Pump, B) Kangaroo 224 Enteral Feeding Pump Refurbished 74862

2012/06/27 74551

2012/06/27 74552

2012/06/27 74838

2012/06/28 Z-1826-2012

2012/06/28 GE Healthcare GE Healthcare, Aestiva/5 7900 SmartVent" Z-1787-2012

2012/06/28 Z-1822-2012

2012/06/28

MHRA

MHRAFresenius Medical Care DALI 500 (REF 9798201), DALI 750 (REF 9798211), DALI 1000 (REF 9798221), DALI 1250 (REF 9798241) Kit MHRA

Liko AB Liko® FreeSpan™ Traverse and FreeSpan Ultra Twin™ Traverse, 3EN110750-01 thru – 04, shipped prior to November 2007 MHRA

MHRA

MHRA

Health Canada

Health Canada

Health CanadaHowmedica Osteonics Corporation A) Austin Moore Hip EndoprosthesisB) Trident PSL HA Solid Back Acetabular Shell Health Canada

Health Canada

Smiths Medical ASD Inc A) CADD-PCA Ambulatory Infusion PumpB) CADD-Plus Ambulatory Infusion Pump Health Canada

Health Canada

Health Canada

Health Canada

Beckman Coulter Inc. Whole Blood Lysing Reagents (Model/Part no.: 6602764, 6603152 & Affected serial no.: 7125011K, 7087007K, 7125012K, 7087008K) Health Canada

Health Canada

Health Canada

Beckman Coulter Inc. Synchron Systems Modular Phosphorus (PHOSM) Reagent (Model no.: 467868; lot no.: M108021, M110381, M109034, M112164, M112274) Health Canada

Beckman Coulter Inc. Synchron Systems Total Protein (TP) Cartridge Reagent for use on DXC Systems (Model no.: 442740; lot no.: all) Health Canada

GE Medical Systems A) Optima XR220AMX X-Ray System; B) Optima XR220AMX X-Ray System - Main Unit Health Canada

Fresenius Medical Care Naturalyte Liquid Acid Concentrate and Naturalyte GranuFlo (powder) Acid Concentrate FDA

FDA

Ultradent Products, Inc Peak SE Primer Kits (4 syringes per kit) ( Product code : 5135 and Affected lot no.: B6Z4K) FDA

Tripath Imaging, Inc. A) PrepStain Syringing Pipettes 240; B) PrepStain GYN 480 Disposable Test Kit with PreCoat Slides; C) PrepStain Installation Kit (PreCoat); D) Manual Method 1: 480 Test Kit (PreCoat); E) PrepStain GN 480 Disposable Kit (Model/Catalog no.: A) 490517; B) 490523; C) 490528; D) 490529; E) 490542)

FDA Event ID: 61737; Recall number: Z-1811-2012 to Z-1815-2012


























2012/06/29 MDA/2012/037

2012/06/29 Invacare All Birdie and Flamingo mobile patient hoist carabiners MDA/2012/038

Reusable transoesophageal echocardiography, transvaginal and transrectal ultrasound probes (transducers) MHRA

MHRA



Major Safety Alerts in June 2012




Type III

Class I

Type III

Type II N.A.Type III Uninet Technology LTD



Type II

Type II

Type I Stryker China Ltd





A) Medicare; B) Promed (Tel : 2865 2938/ 9656 7063)





Type II N.A.

Type II

Type II

Type II

Type III

Type II N.A.

Type II N.A.


Type III

Type II Cardinal Health

Type III Swedish Trading Co. Ltd.


Type III

Type III N.A.

Type III N.A.




St. Jude Medical (Hong Kong) Ltd.


Long Hin Medical Limited/ Olympus Hong Kong and China

Limited

Type II


NA Abbott Laboratories Ltd.

FSN N.A.



NA BDFSN N.A.MDA N.A.FSN N.A.FSN N.A.

FSN

Class I Moog Controls Hong Kong Ltd.

Class II

Class II Direct Health Ltd.

NA Citicon (Hong Kong) Limited

NA Tin Hang Technology Limited

FSN N.A.

FSN N.A.

FSN N.A.

FSN

FSN



The Industrial Promoting Co. Ltd.


Philips Electronics Hong Kong Ltd.


NA

FSN Covidien Hong Kong Limited

NA

Type III

Type II N.A.

Type II

Type II

Type II


Type II N.A.


Type III Radiometer China (RCHN)



Type III MDSS GmbH (Germany)

Type III N.A.

Press Release N.A.FSN N.A.


FSN N.A.

FSN Sysmex Hong Kong Ltd.

FSN N.A.

FSN N.A.







FSN N.A.

FSN CareFusion Hong Kong Ltd.

FSN N.A.

FSN N.A.

FSN MR Holdings (HK) Limited

FSN N.A.

FSN TERUMO CHINA (H.K.) LTD.

FSN

FSN

Class II

Class II N.A.

Class II Stryker China Ltd


NA BrainLAB LtdType I N.A.Type II N.A.Type II N.A.Type II Abbott Laboratories Ltd.

FSN Citicon (Hong Kong) Ltd

Type II bioMerieux China Ltd.

Type II

Type II Boston ScientificType II Direct Health Ltd.

Type II


FSN N.A.






FSN N.A.

FSN N.A.

FSN N.A.

FSN N.A.

FSN N.A.

FSN N.A.

type II N.A.

type III

Type III N.A.

Type III Stryker China Ltd

Type III

Type III Goodman Medical Supplies Ltd

Type III bioMerieux China Ltd.

Type III N.A.

Type III Sybron Dental Specialties


Type III

Type III Covidien Hong Kong Limited



Type III

Class I

Class I

Class II N.A.

class III





Fresenius Medical Care Hong Kong Ltd.


Becton Dickinson Asia Limited (BD)

MDA N.A.

MDA Direct Health Ltd.

Major Safety Alerts in May 2012


2012/05/02 2012/003/027/081/027

2012/05/02 73289

2012/05/02 Terumo Spectra Optia® Apheresis System, all Serial Numbers with Software Version 5 or higher 2011/005/025/401/004

2012/05/02 2012/004/024/081/016

2012/05/02 72651

2012/05/02 Maquet Magnus Carbon Fibre Table Top, model no.: 1180.16F5 72980

2012/05/02 Philips Medical Systems Brilliance 64 Slice CT System - Main Unit, Model no.: 4550 110 00921 72982

2012/05/02 73249

2012/05/02 73246

2012/05/02 73302

2012/05/02 Wright Medical Technology Inc. Dynasty Biofoam Shell 72874

2012/05/02 72976

2012/05/02 71318

2012/05/02 72851

2012/05/02 Cordis (a Johnson & Johnson company) Cordis S.M.A.R.T. Transhepatic Biliary Stent 73373

2012/05/02 Kerr Corporation Freedom Cordless LED Headlight 72749

2012/05/02 Ormco Corporation Arch Hooks 72992

2012/05/02 Innovatek Medical Inc BioStrip LH Ovulation Test 72936

2012/05/02 2012/004/023/291/009




St. Jude Medical Brio™ (Deep Brain Stimulator), Product Code: 65-6788, Affected lot number: up to 13854243 MHRA

HSIN Ten Enterprise Electro Reflex Energizer, Product Code: SR001A2, Affected lot number: from 828015484 to 828015813 Health Canada

MHRA

Topcon Medical Laser Systems Topcon PASCAL and PASCAL Streamline, 2RG Sofrware v2.01 Endpoint Management Enable MHRA

Nobel Biocare AB 30 Degree Multi-Unit Abutment Nobelactive Int RP 3.5mm, Model no.: 34369, Lot no.: 464886 Health Canada

Health Canada

Health Canada

Vapotherm A) Insolare Nasal Cannula (Infant), Imi1300B) Insolare Nasal Cannula (Intermediate Infant), Imi1300BC) Insolare Nasal Cannula (Premature), Imn1100AD) Insolare Nasal Cannula (Neonatal), Imn1100BE) Single Prong Nasal Cannula (Infant), Isolo1300

Health Canada

Beckman Coulter Access Total T4 Reagent (Access System, Dxi 600 System and Dxi 800 System) Model no: 33800 Health Canada

Beckman Coulter Beckman Coulter AU2700, AU5400 and Immunochemistry System - Urinary/CSF Protein Assay, Model no.: OSR6170, OSR6270 Health Canada

Health Canada

Invacare Corporation TDX SP Power Wheelchair [Model No.: TDXSP-CG, TDXSP-CG-GT, TDXSP-MCG, TDXSP--MCG-GT] Health Canada

Carefusion 209, Inc. DBA Carefusion A) Nicolet EDX System Software [Model No.: 828-050000, 828-062900] version 2.9.2; B) Nicolet EEG Software [Model No.: 828-063500, 828-063600] version 2.9.2 Health Canada

Zimmer Inc. A) Nexgen Complete Knee Solution - CR (Cruciate Retaining) Articular Surface; B) Nexgen Complete Knee Solution - Articular Surface Anterior Constrained; C) Crosslinked Polyethylene Articular Surfaces - A-B/3-4 Striped Yellow; D) Crosslinked Polyethylene Articular Surfaces - A-B/1-2 Purple

Health Canada

Health Canada

Health Canada

Health Canada

Health CanadaBioRad/ DiaMed GmbH IH-Com Full kit version (Data Management and Result Interpretation Software) (Product Ref: 009000) MHRA




















2012/05/02 Doctors Research Group Kryptonite Bone Cement® 2012/004/024/081/008

2012/05/02 2012/004/023/291/001

2012/05/02 Ethicon Products PDS®Cord, and PDS®Cord II 2012/004/024/601/002

2012/05/02 Fannin NI Ltd LIP W11183 Legionella Medium + BCYE Growth Supplement (Affected lot no.: 1463779807) 2012/004/013/081/024

2012/05/02 Life Technologies Corporation SeCore GSSP Set 2012/004/023/291/005

2012/05/02 Orascoptic Laser Loupes (shipped since 2008) 2012/004/020/291/015

2012/05/02 12/004/017/081/023

2012/05/02 2012/004/024/081/014

2012/05/02 Siemens Healthcare Diagnostics ADVIA Centaur® HCV kit (Ref no. 03438099) 12/004/025/601/002

2012/05/03 Elekta XVI (X-Ray Volume Imaging system) R4.5 Elekta Ltd 200 01 507 047

2012/05/04 Hill-Rom Affinity Four Birthing Bed Solar-Med Limited Mod 471

2012/05/08 Advanced Sterilization Products N.A.

2012/05/09 2012/004/003/401/013

2012/05/09 Jenx Headrest brackets 2012/003/027/601/0072012/05/09 Mast Group Cephalexin 30ug Cartridges Discs [CFX30C; Lot no: 298700] 2012/005/001/601/012

2012/05/09 2012/004/013/081/006

2012/05/09 Water Pik Inc SinuSense™ Water Pulsator nasal irrigation devices N.A.

2012/05/09 2012/005/003/081/001

2012/05/09 Ceraver CERAPLUG, all batches sizes 1 to 6, references 4501-4502-4503-4504-4505-4507 2012/004/020/291/024

2012/05/09 Computerized Medical Systems (CMS) XiO Release 4.30, Reference no.: 33941 2012/005/003/081/007

2012/05/09 Ortho-Clinical Diagnostics Inc. Vitros® 5600 integrated system software version 1.6 and below

2012/05/09 Plasma Surgical Ltd Single Use Handpieces for the PlasmaJet® Neutral Plasma Surgery System 2012/004/027/601/009

2012/05/10 Endoscope accessory holder- all manufacturers MDA/2012/0242012/05/11 Liberation treatment for multiple sclerosis N.A.

2012/05/14 Terumo CVS Sarns™ Antegrade Cardioplegia Cannula Firm initiated AA-2012-007-R

2012/05/15 2012/003/021/401/014

MHRADr Arabin GmbH & Co.KG Cerclage Pessaries Type ASQ (perforated), Model/Part no.: ASQ 70/21/35, Affected lot no.: W 33/11/2 MHRA

MHRA

MHRA

MHRA

MHRAPhilips Healthcare Easy Diagnost Eleva DRF, System code.: 706037 (all EasyDiagnost 4.0 with either one or two detectors) MHRA

Philips Healthcare HeartStart MRx monitor/defibrillators, Model/ Part no.: M3536A with software versions, R.01.00, R.02.00 and R.03.01 MHRA

MHRA


Hager & Werken GmbH & Co. KG Brilliant—Mouth mirror No.4 [Model no.: 605400 Lot no: MD-4/31] MHRA

MHRAMHRA

McKesson Medical Imaging Company Horizon Medical Imaging (HMI) [versions 11.5, 11.5.1, 11.5.2, 11.6, 11.7 and 11.8] MHRA

FDA

Zimmer NexGen PRI Femoral and Provisional Impactor/Extractor (00-5901-026-00) and the replacement jaw assembly (00-5901-026-40) MHRA

MHRA

MHRA

MHRA 2012/004/030/601/002

MHRA

MHRAFDA

Wassenburg Medical Devices Wassenburg Automatic Endoscope Reprocessor (Model no. WD440 & WD440PT) MHRA





















http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm303538.htm


2012/05/15 73493

2012/05/15 BioHorizon Implant Systems BioHorizons 0.050 One-Piece Hex Driver 735172012/05/15 BioMet 3i Incise Coping CBZR0102 72143

2012/05/15 73453

2012/05/15 73305

2012/05/15 Kensey Nash Corp Collagen Dental Membrane [Model No.: 20650-01, 20650-02, 20650-03] 72842

2012/05/15 Terumo CVS Cardiovascular Procedure Kit (X-Coated Perfusion Pack) [Model No.: 73673, 73679] 73480

2012/05/15 GE Healthcare (Japan Corporation) Discovery Magnetic Resonance Imaging [Discovery MR750W 3.0T] 73368

2012/05/15 71582

2012/05/15 73105

2012/05/15 73709

2012/05/15 73276

2012/05/15 73277

2012/05/15 2012/005/009/291/018

2012/05/15 Becton Dickinson BD Gram Crystal Violet 250ml and BD Gram Stain Kit 2012/005/009/291/015

2012/05/15 DePuy (a Johnson & Johnson company) DePuy DeltaMotion Acetabular Cup 2012/005/009/081/021

2012/05/15 Mini Crosser A/S Mini Crosser M1 scooters produced before 14/12-2010 2011/012/012/081/003

2012/05/15 PaloDEx Group Oy/ Instrumentarium Dental Instrumentarium OP-300 (Model: 1.14 and 1.15) 2012/005/002/081/014

2012/05/15 2012/005/008/601/004

2012/05/16 DePuy (a Johnson & Johnson company) Side Fire Needle, part of Confidence Spinal Cement System Firm initiated N.A.

2012/05/17 Ormco Corporation Enlight Unidose NA

2012/05/17 Endeavour Industries Pty Ltd Quad (4 X Point) Walking Stick N.A.

Sigma International General Medical Apparatus Spectrum Infusion Pump with Master Drug Library - Sigma Spectrum MDL Editor Software, 'MDL Editor Software v6.2.4 Health Canada


Steris A) Steris 5085 Surgical TableB) Steris 5085SRT Surgical Table Health Canada

Roche Diagnostics A) Reduced On-Board Stability Sample Cleaner 1B) Reduced On-Board Stability Sample Cleaner 2 Health Canada

Health Canada

Health Canada

Health Canada

Shimadzu Corporation A) Mobile X-Ray System Mobile DaRt Evolution and RAD SpeedB) Digital Radiography CXDI Wireless Health Canada

Bomimed Inc A) RespondPRO Adult and Child Resusitator - Feather Flex Disposable Manual Resusiators; B) RespondPRO Adult and Child Resusitator - Disposable Resuscitator Health Canada

Berchtold Medizin-Elektronik GMBH Operon Surgical Table Model D850 (Affected lot no.: 3501110-S10032, 3501110-S10040, 3501110-S10074, 3501110-S10075, 3501110-S10077, 3501110-S10145, 3501110-S10270)

Health Canada

Roche Diagnostics GmbH A) Salicylate for Roche Cobas Integra, c311, c501, and c502; B) Salicylate for Roche Cobas Integra, c311, c501, and c502 Health Canada

Roche Diagnostics GmbH A) Cobas Integra C-Reactive Protein (Latex)(CRPL2) Appl. for C.F.A.S. B) Cobas Integra C-Reactive Protein (Latex) High Sensitive (CRPHS) C) 24K Irrigation System - Remote Control D) Cobas C-111 C-Reactive Protein (High Sensitive Assay) E) C-Reactive Protein Gen.3 (CRPL3) F) Hitachi Tina-Quant C-Reative Protein(Latex) High Sensitive Assay (CRP) G) CRPL3 (C-Reactive Protein Gen. 3) for Cobas C701 Analyzer H) CRPHS (Cardiac C-Reactive Protein (Latex) High Sensitive)

Health Canada

Baxter Healthcare SA Baxter pump compatible blood set (Product code: VMC-9609, Affected Lot no: 11K21V628) MHRA

MHRA

MHRA

MHRA

MHRA

Siemens Healthcare Diagnostics LabPro V4.11 (Compact Disc part no.: 9800-3900, 9800-3906 or 9800-3918) MHRA


TGA

http://www.hc-sc.gc.ca/dhp-mps/alt_formats/xls/compli-conform/recall-retrait/list/md-im_recalls-retrait_apr-june_2012-eng.xls



















http://www.tga.gov.au/safety/alerts-device-quad-walking-stick-120517.htm

2012/05/17 Varian Medical Systems TrueBeam and TrueBeam STx Versions 1.0 through 1.5 CP-07227

2012/05/18 Clever Chek blood glucose monitoring system. MDA/2012/027

2012/05/18 Biomet Troch Nail, Long 11MM, Right 34 CM Peritrochanteric Nail System (Model no.: 28234) Z-1478-2012

2012/05/18 Z-1486-2012

2012/05/18 Alere 1) Alere Triage CardioProfiler Panel PN 97100CP; 2) Alere Triage Profiler SOB Panel, PN 97300 Z-1466-2012 to Z-1467-2012

2012/05/18 Z-1493-2012

2012/05/18 GF Health Products LUMEX A Graham-Field Brand, Bed End Sert. Low/Full-electric, Plastic Panels Z-1536-2012

2012/05/18 Covidien Roticulator Single Use Stapler N.A.

2012/05/21 Abbott Molecular Inc N.A.

2012/05/21 Boston Scientific Boston Scientific Profile™ Single-Use Pediatric Snares Boston Scientific 90765080-FA (AB)

2012/05/22 Airox SA (Covidien) Legendair™ Single Branch, Legendair™ Double Branch and Supportair™ 2012/003/030/081/015

2012/05/22 Synthes Minimally Invasive Reduction Screw (MIRS) 2012/005/009/081/0152012/05/22 Medica- Europe MERCI and MERCI-L (Articles 2618050 and 2618040) 2012/005/011/081/001

2012/05/22 Philips Medical Systems (CLE) Inc. Brilliance iCT and iCT SP (Cooling Unit Welding Joint Detaches) 2012/005/011/081/008

2012/05/22 2012/005/014/291/024

2012/05/22 2012/005/014/291/019

2012/05/22 ArjoHuntleigh Encore, Chorus and Sara Plus Standing Aids 2012/004/012/401/008

2012/05/22 Arrow International ARROWg+ard Blue®, ARROWg+ard Blue® Plus 2012/005/016/081/004

2012/05/22 Fujifilm Europe QuickGene DNA whole blood kit S CE IVD 2012/005/014/291/014

2012/05/22 Schiller Medical FRED easy defibrillators & FRED easy Life defibrillators 2012/005/011/081/009

2012/05/23 Firm initiated FSCA 11-05-2012

2012/05/24 MOOG Curlin Intravenous Administration Sets N.A.

2012/05/25 Varian True Beam versions 1.0, 1.5.12.0 and below, 1.6.9.5 and below Z-1495-2012

2012/05/25 Caridian BCT COBE Spectra System Blood Warmer (Part no.: 950000000) Z-1504-2012

Varian Medical Systems

MHRA

FDA

Siemens Medical System Siemens-branded linear accelerator with a 550 TxT Treatment Table with a. Siemens brand ARTISTE, ONCOR and PRIMUS Linear Accelerator systems include the 550 TxT" Treatment Table.

FDA

FDA

Siemens Medical System ARTISTE or ONCOR Linear Accelerators in combination with 160MLC (Multi Leaf Collimator) FDA

FDA


Abbott Molecular Inc. Vysis FISH Pretreatment Reagent Kit, [List # 02J03-032]; Vysis Paraffin Pretreatment Reagent Kit, [List# 02J02-032];Paraffin Pretreatment Reagent Kit II, [List# 07J02-002]; Protease I, 250mg x2, [List# 02J08-032];

MHRA

MHRAMHRA

MHRA

Siemens ACUSON S1000 ultrasound systems - 10441701, and the Advanced SieClear spatial compounding feature MHRA

Siemens ACUSON S2000 ultrasound systems - 10041461, 10440017, and the Advanced SieClear spatial compounding feature MHRA

MHRA

MHRA

MHRA

MHRA

Biocompatibles UK Ltd Bead Block [Model no.: EB2S305, EB2S709, EB2S912; Affected lot no.: S10348, S10355, S01345, S10347]

FDA

FDA

FDA




















2012/05/25 Z-1421-2012 to Z-1423-2012

2012/05/25 Leica Biosystems Nussloch Gmbh Vacuum Tissue Processor, Model ASP6025 Z-1473-20122012/05/25 Sandhill Scientific Inc. Insight rev H software Z-1487-20122012/05/25 SenDx Medical Inc ABL80FLEX Blood Gas, pH, Electrolyte, and Metabolite System Z-1384-20122012/05/25 Capatex Medical Neonatal endotracheal tube SCP clamp/holder MDA/2012/0292012/05/28 Baxa Corporation Abacus Total Parenteral Nutrition (TPN) Calculation Software N.A.

2012/05/29 Spacelabs Healthcare Spacelabs Healthcare Pathfinder SL Holter Analyzer, version 1.6.0 2012/005/023/081/003

2012/05/29 SmitCare SmitCare DreamMaster Light Mattress Elevator, Model no. DM300 2012/005/022/601/001

2012/05/29 Siemens AG Siemens syngo RT Therapist Version 4.2 2012/005/022/081/020

2012/05/29 2012/005/021/601/006

2012/05/29 Atom Medical International Inc Dual Incu I, model number 100 2012/005/021/007

2012/05/29 2012/005/021/081/005

2012/05/29 Expanding Orthopedics Inc. XPED Expanding Pedicle Screw System 2012/005/015/081/002

2012/05/29 2012/005/022/081/014

2012/05/29 Natus Medical Incorporated Olympic Cool-Cap System - 60010 2012/005/022/291/018

2012/05/29 2012/005/017/081/004

2012/05/29 2012/005/022/081/013

2012/05/29 Proact Medical LTD Metal Max 90 Laryngoscope Blade 2012/005/021/601/007

2012/05/30 Edwards Lifesciences Edwards Lifesciences N.A.

2012/05/31 Terumo CVS Sarns Modular Perfusion System 8000 Z-1450-2012 to Z-1453-2012

2012/05/31 Zimmer Zimmer Dental Trabecular Metal Implant Z-1510-2012 to Z-1515-2012

2012/05/31 Philips Medical Systems Practix Convenio Mobile X-ray System, Serial no.: PC1-0504 through PC1-0588 FSN MA-FCO 70400049

2012/05/31 Siemens Healthcare Diagnostics Siemens ADVIA Centaur Vitamin D Diluent 2-pack, Reference 10494100 Z-1268-2012

2012/05/31 Codman & Shurtleff Codman ICP Skull Bolt Kit, Product Code: 82-6638 Z-1279-2012

DeRoyal DeRoyal Sterile wound closure strips, sterile surgical kits containing Episeal products and Non-sterile wound closure strips FDA

FDAFDAFDA

MHRAFDA

MHRA

MHRA

MHRA

Siemens Healthcare Diagnostics ADVIA® 1200, ADVIA 1650, ADVIA 1800, and ADVIA 2400 Chemistry Systems, Alkaline Phosphatase (ALPAMP and ALPDEA): Reagent Kit Lots MHRA

MHRA

Edwards Life Sciences Inc Carpentier-Edwards PERIMOUNT Models 2900, 6900P, and 6900PTFX, Carpentier-Edwards PERIMOUNT Magna Models 3000 and 3000TFX, Carpentier-Edwards PERIMOUNT Magna Ease Model 3300TFX, Carpentier-Edwards PERIMOUNT Magna Mitral Model 7000TFX, Carpentier-Edwards PERIMOUNT Magna Mitral Ease Model 7300TFX

MHRA

MHRAHeine Optotechnik GMBH HEINE Standard F.O. Laryngoscope Handle with LED illumination [REF F-008.22.890 & S/N: 1230000000 and 1230999999] MHRA

MHRAM.I. Tech Stent introducer for biliary endoscopic application, diameter 7 Fr, For SHS stent range diameter 10 mm length 4 cm, 6 cm, 8 cm, 10 cm MHRA

Philips Healthcare Computed tomography. Brilliance iCT and iCT SP software version numbers 3.2.0, 3.2.1 or 3.2.3 MHRA

MHRA

FDA

FDA

Philips Electronics HK Ltd

FDA

FDA






http://www.fda.gov/MedicalDevices/Safety/RecallsCorrectionsRemovals/ListofRecalls/ucm305744.htm

















Major Safety Alerts in May 2012


FSN

Type III N.A.

FSN Terumo China (Hong Kong) Ltd.

FSN N.A.

Type III Nobel Biocare Asia Ltd.

Type III MAQUET Hong Kong Limited

Type III

Type III N.A.



Type II

Type II Direct Health Ltd.

Type II CareFusion Hong Kong Ltd.

Type II

Type II

Type II N.A.

Type II Sybron Dental Specialties

Type II N.A.

FSN Bio-Rad Pacific Ltd.




Zimmer PTE Ltd. (Hong Kong branch)

Johnson & Johnson (Hong Kong) Ltd

FSN N.A.

FSN N.A.

FSN

FSN N.A.

FSN Invitrogen Hong Kong Limited

FSN N.A.

FSN

FSN

FSN

FSN Elekta Ltd

FSN Solar-Med Limited

FSN

FSN N.A.

FSN N.A.FSN N.A.

FSN N.A.


FSN

FSN N.A.

FSN Elekta Ltd

FSN Ortho Clinical Diagnostics

FSN N.A.

MDA N.A.Press Release N.A.


FSN N.A.







Type III

Type III N.A.Type III N.A.

Type III N.A.

Type III

Type I N.A.

Type I TERUMO CHINA (H.K.) LTD.

Type II

Type II N.A.

Type II Bomimed Inc

Type II N.A.

Type III

Type III

FSN Baxter Healthcare Ltd

FSN BD

FSN

FSN N.A.

FSN N.A.

FSN

NA

NA Sybron Dental Specialties

Alerts N.A.

Baxter Healthcare Ltd. (Hong Kong)








NA N.A.

MDA

Class II N.A.

Class II

Class II N.A.

Class II

Class II N.A.



NA Boston Scientific

FSN Covidien Hong Kong Limited

FSN Synthes (Hong Kong) LtdFSN Medica- Europe

FSN

FSN

FSN


FSN Cemma Enterprise Co., Ltd

FSN N.A.

FSN

NA

Firm Press Release Moog Controls Hong Kong Ltd.

Class II

Class II Terumo BCT (Hong Kong) Ltd.

TaiDoc Technology Corporation (distributed by BBI Healthcare)






a) Ultronics Enterprises Ltd; b)Lynx Tech

Pacific Medical (Hong Kong) Co. Ltd.


Class II N.A.

Class II Leica Microsystems Ltd.Class II Sandhill Scientific Inc.Class II SenDx Medical Inc

FSN N.A.Class I JASPO Limited


FSN N.A.

FSN

FSN

FSN Long Hin Medical Ltd

FSN Goodman Medical Supplies Ltd.

FSN N.A.

FSN

FSN N.A.

FSN N.A.

FSN

FSN N.A.

NA Goodman Medical Supplies Ltd.


Class II

FSN

Class II

Class II



The Vita Company Ltd. & Efficiency Medical Products Co.

Ltd.

Philips Electronics Hong Kong Ltd.





Major Safety Alerts in April 2012


2012/04/03 Philips Healthcare Brilliance 64 or Ingenuity CT with Software Version 3.5.1 2012/003/027/081/018

2012/04/03 Welch Allyn VSM 200 & 300 series, SPOT Vital Signs, SPOT Lxi Power Cords & Transformers 2012/001/011/401/014

2012/04/03 Wescott Medical Limited Weflow3 Hi-Flo Irrigation Set 2012/003/023/601/004

2012/04/03 2012/003/022/081/001

2012/04/03 GBUK Healthcare TenderTip 24 & 72 Hour Closed Suction 2012/003/021/601/001

2012/04/03 2012/002/007/601/004

2012/04/03 Merck Serono Merck Serono auto-injector Easypod™ 2012/003/001/291/003

2012/04/03 MDA/2012/016

2012/04/03 2012/003/013/081/007

2012/04/03 Codman & Shurtleff MEDSTREAM pump 2012/002/006/081/002

2012/04/05 Animas Corporation One Touch Ping Insulin Pump 72558

2012/04/05 Oxoid Company Brilliance Clarity UTI Plates (MP0324) 71096

2012/04/05 71627

2012/04/05 71838

2012/04/05 Beckman Coulter Coulter ACT 5 Diff Autoloader Hematology Analyzer (175356) 72299




MHRA

MHRA

MHRAConcateno FirstStep hCG Pregnancy Test (FHC-300) [Model/Part no.: FHC-300; Affected lot no.: All lot numbers] MHRA

MHRAMeditech Systems Ltd 22X150S X-tendable catheter mount + elbow [Affected lot no: S21121101 & L09111108] MHRA

MHRA

Finsbury Orthopaedics, Stryker Orthopaedics MITCH TRH acetabular cups/MITCH TRH modular heads (Finsbury Orthopaedics) when implanted with uncemented Accolade femoral stems (Stryker Orthopaedics) MHRA

Agfa Healthcare DX-D 10G, DX-D 10C, DX-D 20G & DX-D 20C - Digital detectors (connected via cable) for Direct Digital imaging size 35*43cm MHRA

MHRA

Health Canada

Health Canada

Beckman Coulter, Inc. A) Unicel DXI 600 Access Immunoassay System - Instrument Class 2B) Unicel DXI 600 Access Immunoassay System - Instrument Class 3C) Unicel DXC 880I Synchron Access Clinical AnalyzerD) Unicell DXI 800 Access Immunoassay - Analyzer-Class 3E) Unicel DXI 800 Access Immunoassay System - Analyzer - Class IIF) Unicel DXC 660I Synchron Access Clincal AnalyzerG) Unicel DXC 660I Synchron Access Clincal AnalyzerH) Unicel DXC 680I Synchron Access Clincal AnalyzerI ) Unicel DXC 860I Synchron Access Clincal AnalyzerJ) Unicel DXI 800 Access Immunoassay Sys-Instrument W/ Spot B Gantry Class 2K) Unicel DXI 800 Access Immunoassay Sys-Instrument W/ Spot B Gantry Class 3L) Unicel DXI 600 Access Immunoassay Sys-Instrument W/ Spot B Gantry Class 3

Health Canada

Baxter Healthcare SA A) Homechoice APD SystemsB) Homechoice Pro APD Systems Health Canada

Health Canada








http://www.mhra.gov.uk/Publications/Safetywarnings/MedicalDeviceAlerts/CON149600http://www.mhra.gov.uk/NewsCentre/Pressreleases/CON149601








2012/04/05 Carl Zeiss OPMI Lumera 700 Opthalmic Surgical Microscope (305953-9900-000 and305953-9920-000) 72041

2012/04/05 Stryker Orthopeadics Trident Offset Cup Impactor T6318 [All Lots Numbers] 72438

2012/04/05 72043

2012/04/05 Elekta Business Area Software Sys. ATA Computerized Medical Sys. Inc. Monaco [Version 3.10.00] 72466

2012/04/05 71571

2012/04/05 Oxoid Limited Oxoid XLS Agar 71097

2012/04/05 Codman and Shurtleff Inc. Codman I.C.P. Express Monitoring System - Microsensor Kit 72434

2012/04/05 BrainLAB A) Microscope Integration Kit Zeiss; B) Microscope Integration Leica 664432012/04/10 Healthtronics CRYO-206V and CRYO-206F Procedure Kit Z-1275-2012

2012/04/10 Z-1280-2012 to Z-1281-2102

2012/04/11 Edwards Lifesciences Edwards Lifesciences Ascendra2 Transapical Delivery System 2012/003/015/081/024

2012/04/11 DePuy Orthopeadics DePuy Attune Impaction Handle (Model/Part no.: 254401010) 2012/004/002/081/025

2012/04/11 DePuy Orthopeadics DePuy Fenestrated Open Alignment Guide (Model/Part no.: 279726401) 2012/003/013/081/009

2012/04/11 Beckman Coulter Access Immunoassay Systems, Vitamin B12 Reagent Kit 2012/003/028/601/004

2012/04/11 2012/004/004/081/004

2012/04/11 2012/003/030/291/010

2012/04/11 Siemens Healthcare Diagnostics Ltd lratus® CS Acute Care'" NT• proBNP TestPak reagent (CPBNPM) 2012/003/030/601/003

2012/04/11 2012/004/003/601/006

2012/04/11 Teleflex Hudson RCI BiteGard® oral bite block 2012/004/003/081/0252012/04/11 Rocket Medical Rocket® Pleuraseal IV(4) Chest Drainage Bottle 2012/003/028/601/0022012/04/11 Woodway Gmbh Medical PPS series treadmills 2012/003/027/081/016

2012/04/11 2012/004/002/081/006

Health Canada

Health CanadaBecton Dickinson and Company BD BBL Fildes Enrichment [Model No.: 211866; Lot No.: 1186346, 1229762] Health Canada

Health Canada

Supersonic Imagine A) SuperSonic Aixplorer Ultrasound System - Main Unit [SSIP90019]B) SuperSonic Aixplorer Ultrasound System - Linear Probe [SSIP09002]C) SuperSonic Aixplorer Ultrasound System - Curved Array Probe [SSIP90030]D) SuperSonic Aixplorer Ultrasound System - Probe SE12-3 [SSIP90068]

Health Canada

Health Canada

Health Canada

Health CanadaFDA

Christie Medical Holding 1) VeinViewer (R) by Luminetx, Model Number VV1.0, Part No: P00399-L; 2) VeinViewer (R) by Luminetx, Model Number VV1.1 GS, Part No. P00800-L FDA

MHRA

MHRA

MHRA

MHRA

Baxter Healthcare SA Homechoice Disposable Sets (Model no.: R5C4455, R5C4478, R5C4479, R5C4479E) and Manifold Sets (Model no.: R5C4427) MHRA

Stryker Medical Epic Critical Care beds, Epic Zoom Critical Care beds and Secure II beds. Catagloue no.: 2030, 2040, 2031, 3002, 3221Affected lot no: Devices manufactured between 1st September 2004 and 30th November 2007

MHRA

MHRA

Siemens Healthcare Diagnostics Ltd Dimension Vista® Total Prostate Specific Antigen (TPSA) Flex® reagent cartridge (K6451) MHRA

MHRAMHRAMHRA

Greiner Bio-One A) Item No. 450235 VACUETTE® QUICKSHIELD Complete PLUS - Safety Tube Holder with 21G x 1" VISIO PLUS Needle;B) Item No. 450239 VACUETTE® QUICKSHIELD Complete PLUS - Safety Tube Holder with 21G x 1.5" VISIO PLUS Needle;

MHRA























2012/04/11 2012/004/003/081/012

2012/04/11 Instrumentation Laboratory HemosIL von Willebrand Factor Activity (Part No. 0020004700) 2012/004/003/081/021

2012/04/11 Ipsogen BCR-ABL Mbcr IS-MMR DX Kit , ref FQPP-10-MMR-DX-CE 2012/003/028/081/020

2012/04/11 2012/004/002/081/020

2012/04/12 MDA/2012/019

2012/04/14 Oral swabs with a foam head MDA/2012/020

2012/04/17 2012/004/011/081/029

2012/04/17 Philips Healthcare Allura systems. Actuator Monitor Ceiling Suspension (MCS) 2012/004/011/081/014

2012/04/17 Stryker Orthopaedics Restoration Modular Cone Body Trials 2012/004/010/081/0092012/04/17 Gambro Industries Prismaflex/Prisma ST 100/150 Sets [Ref.: MEY-2012-01] 2012/004/010/081/020

2012/04/17 GE Medical Systems READY View application software (GE Ref: 80139) 2012/004/016/291/002

2012/04/17 Ormco Corporation Damon 3MX Bicuspid Brackets NA

2012/04/17 Abbott Diagnostics Ltd ARCHITECT STAT Troponin-I, List Number 2K41-28, Lot 74264UN11 12/004/012/601/005

2012/04/17 2012/003/030/291/006

2012/04/18 CP-03063

2012/04/18 Varian Medical Systems 4D Integrated Treatment Console (4DITC) versions 8.1.3 to 8.8 CP-03556

2012/04/19 Z-1420-2012

2012/04/19 N.A.

2012/04/19 Z-1390-2012

2012/04/19 Ergolet ApS Ergolet N.A.

2012/04/20 72876

2012/04/20 Biomerieux, Inc. Vitek 2 AST-GN27 card [Model No.: 22245; Lot No.: 267215010] 723862012/04/20 Elekta Limited MLCi and MLCi2 radiation heads Elekta Ltd 200 01 403 002

IDEV Technologies SUPERA VERITAS® Interwoven Self-Expanding Nitinol Stent Peripheral Vascular System (6F and 7F) Model/Part no.: All Affected lot no.: All

MHRA

MHRA

MHRAEthicon Endo-Surgery Harmonic® hand piece Harmonic® Blue hand piece and Blue test tip_HPBLUE, HP054 MHRA

Air- or gas-pressurised spray devices for application of sprayable fibrin sealants used for intra-operative haemostasis. MHRA

MHRAPhilips Healthcare Brilliance 6, Brilliance 16, Brilliance 40, Brilliance 64, Brilliance CT Big Bore, iCT, iCT SP and Ingenuity CT MHRA

MHRA

MHRAMHRA

MHRA


MHRA

Abbott Point of Care i-STAT® PT/INR cartridge with List Numbers 04J50-01, 04J50-02, 03P89-24 (All lots beginning with R11 and R12) MHRA

Varian Medical Systems 4D Integrated Treatment Console (4DITC) v8.6 or 8.8 in combination with treatment planning systems



Baxa Baxa EVA TPN bags for administering parenteral nutrition solutions. Sold under three brand names: Exacta Mix EVA Bags, Exacta Mix Dual-Chamber EVA Halobag, and Baxa Calibration Bags FDA

Pharmaceutical Innovations Other-Sonic Generic Ultrasound Transmission Gel manufactured June through December 2011 FDA

Siemens Siemens ADVIA Centaur Cortisol Assay, Model/Part no.: 04610138 (1 0321 026)- 250 Test kit 04610049(10309078)- 50 Test kit 04611509 (1 0335503)- 250 REF FDA

Siemens AG A) Mevatron Linear Accelerators [Model No.: 4504200]B) Oncor Expression Digital Linear Accelerator [Model No.: 7360717]C) Artiste MV-Linear Accelerator - Main Unit [Model No.: 8139789]D) Oncor Impression 3D Plus [Model No.: 5857912]

Health Canada

Health Canada


















2012/04/20 72450

2012/04/20 72657

2012/04/20 71593

2012/04/20 Vascutek Ltd Vascutek Gelweave Vascular Prothesis (Model/Part no.: 732030) 72862

2012/04/20 Medtronic N'Vision Application Card 72742

2012/04/20 Gemoscan Canada Hemocode Blood Collection Kit 72297

2012/04/20 Roche Diagnostics Online DAT Benzodiazepines II for Cobas Integra Analyzers 72332

2012/04/20 72650

2012/04/20 72655

2012/04/20 72451

2012/04/20 72547

2012/04/20 Siemens AG Syngo Mammocad 72852

2012/04/20 2-Channel Vacuum Unit 72754

2012/04/20 Stryker Medical Impression 1.5 Non-Powered Support Surface_2981-000-997, 2981-000-999 72850

2012/04/23 Smith & Nephew Trauma Pins and Drills (various models) R1207

2012/04/23 Q-MED Macrolane NA2012/04/24 Cameron Health Cameron Health SQ‐RX® Pulse Generator, Model Number 1010 2012/004/002/081/002

2012/04/24 2012/004/012/601/006

2012/04/24 GE Healthcare Rear Pedestal Air Supply Hose on Optima MR450w with GEM 2012/003/027/081/005

2012/04/24 Gen-Probe GTI Diagnostics Inc LIFECODES® Pak12G® [Various Lot Numbers] 2012/004/017/081/016

2012/04/24 Siemens AXIOM Artis or Artis Zee operated in conjunction with a wireless foot switch 2011/011/021/081/014

2012/04/24 Gen-Probe GTI Diagnostics Lifecodes Quikscreen QS12G 2012/004/017/081/0142012/04/24 Likvor AB Celda tools_CT001-SV-02, CT001-EN-02, CT001-DA-02, CT001-FI-02 2012/004/017/081/001

Siemens AG A) Mevatron Linear Accelerators; B) Oncor Expression Digital Linear Accelerator; C) Artiste MV - unité principale d'accélérateur linéaire; D) Oncor Impression 3D Plus Health Canada

Smiths Medical ASD Inc CADD High Volume Administration Sets (Model/Part no.: 21-7081v-01 and 21-7381-01) Health Canada

SuperSonic Imagine A) SuperSonic Aixplorer Ultrasound System - Main Unit; B) SuperSonic Aixplorer Ultrasound System - Linear Probe; C) SuperSonic Aixplorer Ultrasound System - Curved Array Probe; D) SuperSonic Aixplorer Ultrasound System - Probe SE12-3

Health Canada

Health Canada

Health Canada

Health Canada

Health Canada

GE Medical Systems A) Brivo XR285AMX X-Ray System; B) Optima XR220AMX X-Ray System; C) Optima XR200AMX X-Ray System Health Canada

Ortho-Clinical Diagnostics Inc. A) VITROS 5600 Integrated System (6802413) - InstrumentB) VITROS 5600 Integrated System (6802413) C) VITROS 4600 Chemistry System (6802445) - Hardware

Health Canada

Beckman Coulter Inc. A) Unicel DXC 600i Synchron Access Clinical System Incubator BeltB) Access 2 Immunoassay System Incubator BeltC) Access 2 Immunoassay System Incubator BeltD) Synchron LXI 725 Clinical System Incubator Belt

Health Canada

Beckman Coulter Inc. A) Unicel DXC 800 ProB) Unicel DXC 880i Health Canada

Health Canada

Health Canada

Health Canada

Smith & Nephew HK

MHRAMHRA

Galil Medical 17G Cryoablation Needle Holder FPRPR4014 (FSCA identifier: PAF12-02); [Model no.: FPRPR4014; Affected lot no.: N7729-XXX; N7890-XXX; N7975-XXX; N8185-XXX; and N9438-XXX] MHRA

MHRA

MHRA

MHRA

MHRAMHRA
















http://www.mhra.gov.uk/NewsCentre/CON149797








2012/04/24 M.A. Arain & Brothers (Pvt) Ltd Laryngoscope battery handles_670160-000030 and 670160-000040_041511 2012/004/016/081/021

2012/04/24 2012/003/013/081/005

2012/04/24 Philips Healthcare DigitalDiagnost with software version 2.x and the image stitching option 2012/004/018/081/017

2012/04/24 Beckman Coulter UniCel® DxH™ 800 Coulter® Cellular Analysis System, PN 629029 2012/004/013/601/002

2012/04/24 Biomet 3i Dental Full Osseotite® Tapered Certain® Implant, item no IFNT611; lot no 2011110798 2012/004/013/081/012

2012/04/25 Bayer HealthCare MEDRAD® CONTINUUM PUMP AND TUBING SET NA

2012/04/27 Z-1337-2012

2012/04/27 Z-1401-2012 to Z-1419-2012

2012/04/27 BD Diagnostics BD PrepMate Syringing Pipette BD NA

2012/04/30 BD NA

MHRA

Pennine Healthcare Procedure packs containing Sarns™ Soft-Flow™ aortic cannula with angled tip manufactured by Terumo MHRA

MHRA

MHRA

MHRA

Prism Technologies Limited

Philips Medical Systems Brilliance Workspace IntelliSpace Portal, M/N 728269 (System Code: 881001, Software release 4.0.0) FDA

MOOG Non-DEHP Microbore Administration Sets, Epidural Administration Sets (Model no: 340-4114, 340-4115, 340-4126, 340-4127, 340-4128, 340-4128v, 340-4130, 340-4130v, 340-413, 340-4137, 340-4144, 340-4162, 340-4164, 340-4165, 340-4166, 340-4168, 340-4169 and 340-4123) FDA

BD Diagnostics BD Phoenix System Software, Cat. No. 448035/448046, and BD Phoenix Update Disks (PUD), Cat. No. 441107/448047








Major Safety Alerts in April 2012


FSN

FSN N.A.

FSN N.A.

FSN Concateno

FSN GBUK Healthcare

FSN Meditech Systems Ltd

FSN Merck Pharmaceutical (HK) Ltd.

MDA Stryker China Ltd


FSN

Type III

Type II


Type III Baxter Healthcare Ltd







Type I Stryker China Ltd

Type II BD

Type II Elekta Ltd

Type II Prism Technologies Limited

Type II

Type II

Type II BrainLAB LtdClass II N.A.

Class II N.A.

FSN Goodman Medical Supplies Ltd.

FSN

FSN




FSN

FSN

FSN N.A.FSN N.A.FSN N.A.

FSN Mekim Ltd








FSN N.A.

FSN N.A.

FSN Johnson & Johnson (HK) Ltd.

MDA N.A.

MDA N.A.

FSN

FSN

FSN Stryker China LtdFSN Gambro Hong Kong Ltd.

FSN

NA Sybron Dental Specialties

FSN

FSN

NA

NA

Class II JASPO Limited

NA N.A.

Class II

NA N.A.

Type I

Type II bioMerieux China Ltd. NA Elekta Ltd










Type II

Type II N.A.


Type II Keymax Technology (HK) Ltd.


Type III N.A.

Type III

Type III

Type III Ortho Clinical Diagnostics



Type III

Type III ITO Company Limited

Type III Stryker China Ltd

NA Smith & Nephew Ltd.

NA Q-MED International LtdFSN N.A.

FSN Galil Medical

FSN


FSN

FSN N.A.FSN N.A.







FSN N.A.

FSN N.A.

FSN


FSN Ositek (HK), Inc. Ltd

NA Prism Technologies Limited

Class II

Class II Moog Controls Hong Kong Ltd.

NA BD

NA BD



Major Safety Alerts in March 2012


2012/03/02 Z-1060-2012

2012/03/02 Z-1074-2012 to Z-1075-2012

2012/03/02 Z-1090-2012

2012/03/02 Z-1098-2012

2012/03/06 Philips Medical Systems HeartStart FR3 Carry Case

2012/03/06

2012/03/06 2012/002/027/601/004

2012/03/06 Aesculap AG Columbus Rev F Tibia Offset Cemented 2012/002/029/081/018

2012/03/06 Beckman Coulter UK Ltd Coulter TruColor Giemsa Stain, Coulter TruColor May-Grunwald Stain 2012/002/024/601/003

2012/03/06 Bio-Rad Medical Diagnostics GnbH Biotestcell- I11, I11E 2012/002/027/291/013

2012/03/06 GE Healthcare GEHC Infinia Nuclear Medicine systems 2012/003/002/291/007

2012/03/06 Fujifilm Medical Systems Fujifilm FDR-1000AWS, FDR-2000AWS 2012/002/016/291/012

2012/03/06 Interlerad Medical Systems INTELEPACS Versions 3.2.1 and up [reference: EW241135] 2012/002/028/291/013

2012/03/06 Roche Diagnostics Ltd Cobas c-pack MULTI [cobas c311 cobas c 501 cobas c 502]

2012/03/06 Sybron Dental Specialities AlgiNot FS Volume (Model/Part no.: 34683, 34682; Affected lot number: 1‐1017) 2012/002/027/081/019

2012/03/06 Siemens Healthcare Diagnostics Enzygnost® HBsAg 6.0 2012/002/022/601/006

2012/03/06 Thermo Fisher Scientific Oxoid Ready Poured Plate, CLED Agar 2012/002/028/601/003

2012/03/06 Medtronic N.A.

2012/03/07 Standard Diagnostics, Inc SD Bioline HIV 1/2 v3.0 N.A.




Ascension Orthopedics, Inc Ascension Orthopedics First Choice Partial Ulnar Head System ("DRUJ System") (Model/Part no.: DRUJ-610-1445-WW, DRUJ-610-1455-WW, DRUJ-610-1465-WW, DRUJ-610-1645-WW, DRUJ-610-1655-WW, DRUJ-610-1665-WW, DRUJ-610-1745-WW, DRUJ-610-1755-WW, DRUJ-610-1765-WW, DRUJ-610-1945-WW, DRUJ-610-1955-WW, and DRUJ-610-1965-WW)

FDA

Alere San Diego Strep A Rapid Test Cassette (K031784), IST-502 Cassettes; Strep A Twist Rapid Test Cassette (K023766), IST-502T Twist Cassettes FDA

Varian Medical Systems Varian 52-leaf Standard MLC multileaf collimator; 52-leaf Millennium MLC multileaf collimator (Model/Part no.: H52, H54, H56, HHM) FDA

Accuray CyberKnife Robotic Radiosurgery System with 4D Planning procedure option of MultiPlan Treatment Planning System (Model/Part no.: versions 3.0, 3.1, 3.5.1, 3.5.2 and 3.5.3) FDA

MHRA 2012/002/029/291/010

Philips Medical Systems HeartStart FR3 Automated External DefibrillatorsMandatory Software Update MHRA 2012/002/028/291/006

Thermo Fisher Scientific Oxoid Antimicrobial Susceptibility Testing Disc, SXT25 (Sulphamethoxazole\Trimethoprim), CT0052B, Lot 1114277 MHRA

MHRA

MHRA

MHRA

MHRA

MHRA

MHRA

MHRA 2011/011/018/401/009

MHRA

MHRA

MHRA

Medtronic, Inc EnTrust(r) D153DRG, D153VRC, D153ATG, D154VRC, D154DRG and D154ATG and Escudo D144DRG, D144VRC

WHO


















http://www.who.int/diagnostics_laboratory/procurement/120106_final_update_info_sd_bioline_hiv_rtd.pdf

2012/03/07 Varian Medical Systems 4D Integrated Treatment Console and TrueBeam CP-05708

2012/03/07 CP-07007

2012/03/08 71624

2012/03/08 Siemens Healthcare Diagnostics, Inc Dimension Vista System-Magnesium Assay 71628

2012/03/08 Medtronic, Inc ENT Spear Tip Blades, ENT Upcutting Blades 71623

2012/03/08 Supersonic Imagine Aixplorer Ultrasound System (SSIP90019 and SSIP09002 (SL15-4), version 4.X) 71652

2012/03/08 Cinncinnati Sub-Zero Products Steri-Probe Rectal / Esophageal Temperature Probe (Model no..: 491B) 68314

2012/03/08 Siemens Healthcare Diagnostics Factor VIII Chromogenic Assay 71092

2012/03/08 GE Healthcare Innova 4100IQ 71317

2012/03/08 3M Health care Optreoz Sterilizer (Model no.: 125-Z) 71321

2012/03/08 Roche Diagnostics Ltd. Cobas Ampliprep Sample Tubes 71298

2012/03/08 Thermor Ltd. Bios Rollator [Model: 56001; Lot No.: 1110-13870] 71445

2012/03/08 71414

2012/03/08 70975

2012/03/08 70976

2012/03/08 Cinncinnati Sub-Zero Products 115 Volt Warmair 135 Convective Warming Unit 06186, 86186 71305

2012/03/08 71514

2012/03/08 71558


Varian Medical Systems Eclipse Treatment Planning System Eclipse Treatment Planning System, 7.3, 8.0, 8.1, 8.2, 8.6, 8.9, 10.0


Canon Inc. A) CXDI-55C Digital Radiography ImagerB) CDXI-55G Digital Radiography X-Ray ImagerC) Digital Radiography CXDI Wireless

Health Canada

Health Canada

Health Canada

Health Canada

Health Canada

Health Canada

Health Canada

Health Canada

Health Canada

Health Canada

Bomimed Inc A) Air-Flex Anesthesia Mask - Neonatal (OL-081105-00); B) Air-Flex Anesthesia Mask - Infant (OL-081110-00); C) Air-Flex Anesthesia Mask - Child (OL-081120-00); D) Air-Flex Anesthesia Mask - Adult (OL-081130-00, OL-081140-00, OL-081150-00); [Lot No: 072111] Health Canada

Varian Medical Systems EMC issue : A) Eclipse Ocular Proton Planning V1.1 (TPA001075000) ; B) Eclipse Smart Segmentation (TPA001094000); C) Rapidarc, Also known as Dose Dynamic Arc / Volumet (UP9001); D) Eclipse TPS V8.8 (100042024);

Health Canada

Varian Medical Systems MLC issue : A) Eclipse Ocular Proton Planning V1.1 (TPA001075000) ; B) Eclipse Smart Segmentation (TPA001094000); C) Rapidarc, Also known as Dose Dynamic Arc / Volumet (UP9001); D) Eclipse TPS V8.8 (100042024);

Health Canada

Health Canada

Varian Medical Systems A) Varisource IX AfterloaderB) Varisource IX(T) (Transportable) AfterloaderC) Varisource Series 200 HDR Afterloader Model/Part no.: AL13005000, AL13005001 Affected lot number: H600462

Health Canada

Radiometer Medical APS BL80 Flex (with Flex or Basic software)Model/Part no.: 393-839, 903-227Affected lot number: 304157, 304160, 304162 through to 305409, Signal Data Board >May 2011

Health Canada

http://hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/_list/rec-ret_md-im_date_jan-mar_2012-eng.php
















2012/03/08 71681

2012/03/08 71681

2012/03/08 Coloplast A/S Self-Cath Catheter 71495

2012/03/08 ARES Trading S.A. (An affiliate of Merck KGAA Darmstadt, Germany) RebiSmart Auto-Injector 71481

2012/03/08 Smith & Nephew Inc., Endoscopy Division Biosure HA Interference Screw 713232012/03/08 Nobel Biocare AB Nobelactive RP 5x15mm 713682012/03/08 Smith & Nephew Inc Universal Femoral Head, 32mm+12 714442012/03/08 Boston Scientific SoloistTM Single Needle Electrode Boston Scientific 90748268-FA

2012/03/09 B. Braun Medical B. Braun Infusomat Space Pump - US Version Infusion pump (Model no.: 8713050U) Z-1015-2012

2012/03/09 Z-1125-2012

2012/03/09 Zeiss, Carl Inc. Carl Zeiss Microimaging Laser-TIRF and DirectFRAP Z-1129-2012

2012/03/09 Terumo Soft-Flow Aortic Cannula with angled tip Terumo AA-2011-027-R

2012/03/09 Terumo CDI™ Blood Parameter Monitoring System: System Battery Maintenance Terumo AA-2011-019-C

2012/03/09 Z-0713-2012

2012/03/09 Z-0718-2012 to Z-0733-2012

2012/03/13 Medtronic, Inc ATLANTIS™ / PREMIER® / VERTEX ® 876-460, 6860460 and 6905712 2012/003/002/081/021

2012/03/13 P3 Medical Laryngeal airway masks (silicone, reinforced), lot number 11C01 2011/009/028/401/004

2012/03/13 Siemens AG Siemens syngo.plaza, version VA20C_HF01 2012/003/005/081/005

2012/03/13 Siemens AG Siemens syngo.plaza with USB dongle and archive license, version VA20B_HF04 2012/003/005/081/004

2012/03/13 2012/003008/601/001

2012/03/13 ArjoHuntleigh Auto Logic Pump Units and PCBAs 2012/001/017/081/007

2012/03/13 BioLytical Laboratories INSTI HIV-1/HIV-2 Antibody Test Kits 2012/001/020/401/0112012/03/13 Biomet T.E.S.S. Glenoid Anatomic Polyethylene Inlay 2012/003/007/291/0042012/03/13 Critical Diagnostics Presage® ST2 Assay kits 2012/003/007/081/011

2012/03/13 2012/002/020/081/025

2012/03/13 2012/001/024/081/020

Diasorin Inc. ETI-VCA-IGGModel/Part no.: P001606AAffected lot number: 3010580B, 3010580B/1 Health Canada

Supersonic Imagine Aixplorer Ultrasound SystemModel/Part no.: SSIP90019, SSIP09002 (SL15-4), SSIP90055 (SLV16-5) SSIP90030 (SC6-1), SSIP90068 Health Canada

Health Canada

Health Canada

Health CanadaHealth CanadaHealth Canada

FDA

Philips Medical Systems Philips Intellispace Portal, Release 4.0.0.Mandatory Software Update FDA

FDA

Varian Medical Systems Varian brand ARIA Radiation Oncology, ARIA versions 10.0.39 and below, Reference/FSCA Identifier: CP-06070, FDA

AngioDynamics Inc Angiodynamics DuraMax Chronic Hemodialysis Catheter Set (with Cuff from Tip) various models FDA

MHRA

MHRA

MHRA

MHRA

Thermo Fisher Scientific Oxoid Ready Poured Plate BrillianceTM MRSA 2 AgarPO1210A, Lot Number 1203789. MHRA

MHRA

MHRAMHRAMHRA

DiaSorin Inc. ETI-VCA-GModel/Part no.: P001606Affected lot no: 3010580A, 3010580A/1, 3010580A/2 MHRA

Medex/ Guerbet Laboratories IV administration sets [KSB/I/S] & [KSB/PI/S]; Compatible with the SBI CT injector (SBI 5002-CT) in two-bad mode MHRA
























2012/03/14 Acclarent Inc. Acclarent Inspira AIR Balloon Dilation System, size 18x40mm NA

2012/03/16 Abbott Molecular Inc HCV Genotype II m2000 System ROW Combined Application CD-ROM Version 3.0 Abbott Molecular Inc N.A.

2012/03/16 Z-1092-2012

2012/03/16 GE Healthcare GE eXplore Locus Micro CT cabinet x-ray system Model: RS9-80; Part no.: 5134163 Z-0833-2012

2012/03/16 Z-1082-2012

2012/03/16 Z-1184-2012

2012/03/20 Varian Medical Systems All FastPlan versions (Possible error in CT) CP-07299

2012/03/20 Varian Medical Systems Eclipse™ treatment planning system, Versions 7.3, 8.0, 8.1, 8.2, 8.6, 8.9 and 10.0 CP-07504

2012/03/20 2012/003/008/081/001

2012/03/20 Philips Healthcare MultiDiagnost Eleva II, product code 708032, PBL 4.1.x 2012/003/012/291/006

2012/03/20 Smith & Nephew Inc TRIGEN META Semi-Extended Drill Guides, Product code 71654524 2012/003/009/081/004

2012/03/20 2012/003/009/601/009

2012/03/20 Abbott Diagnostics Ltd i-STAT cTnI cartridge (List no.: 06F15-03, 06F15-04, 03P90-25, 600-9009-25) 2012/003/013/081/004

2012/03/20 BrainLAB All Brainlab BrainSCAN and iPlan RT treatment planning software versions 2012/003/013/291/002

2012/03/20 Immucor Inc. Galileo Echo Blood Bank Analyzer Cat No.: 0087000 2012/003/012/291/001

2012/03/20 Medtronic, Inc SynchroMed® II Pump [Medtronic reference : FA535] 2012/003/012/081/006

2012/03/20 2012/003/009/081/027

2012/03/20 2012/003/012/291/002

2012/03/21 Beckman Coulter Inc. Prealbumin (Model no. OSR6175) 71442

2012/03/21 Siemens AG Axiom Luminos DRF System-Main Unit 71452

2012/03/21 71826

2012/03/21 71677

FDA

Siemens AG ARTISTE, ONCOR and PRIMUS Linear Accelerators with RT Therapist Workspace, version 4.1 FDA

FDA

Microsoft Corporation Health Solutions Group Microsoft Amalga - previously known as Microsoft Amalga Unified Intelligence System (UIS) 2009 FDA

Siemens AG Siemens mMLC (Moduleaf) safety bar and trolley labelModel/ Part no.: 110V/60Hz 7334043 & 220V/60Hz 7334050 FDA



Waldemar Link GmbH Trial Neck XXL, length 65mm – Instrument for the MP Reconstruction Prosthesis (Model/Part no.: 131-394/26; 131-394/35) MHRA

MHRA

MHRA

Thermo Fisher Scientific Oxid Antimicrobial Susceptiability Testing Disc CN30 GENTAMICN Model/Part no.: CT0072B Affected lot number: 106811

MHRA

MHRA

MHRA

MHRA

MHRA

One Lambda Inc. Micro SSP™ Allele Specific HLA Class I DNA Typing Tray – AB [Model no.: SSP1-AB; Lot Number: 003, batch 007] MHRA

One Lambda Inc. Micro SSP™ Allele Specific HLA Class I DNA Typing Tray - B*35 [Model no.: SSPR1-35; Lot Number: 002, batch 004] MHRA

Health Canada

Health Canada

GE Medical Systems Information Technologies, Inc. CIC Pro Clinical Information Center (Model/Part no.: CIC-XXXX-XXXXX-XXXXX*) Health Canada

Supersonic Imagine Aixplorer System - Linear Probe (SL-15-4) (Model/Part no.: SSIP09002 (SL15-4)) Health Canada
















http://www.hc-sc.gc.ca/dhp-mps/compli-conform/recall-retrait/_list/rec-ret_md-im_date_jan-mar_2012-eng.php




2012/03/21 71626

2012/03/21 71635

2012/03/21 Hologic SecurView DX Diagnostic Workstation, Software Version 7.3.0 71960

2012/03/21 Lifescan Onetouch Verio IQ Blood Glucose Meters 011-838 71989

2012/03/21 Ortho-Clinical Diagnostics Inc. VITROS Chemistry Products ALT Slides (1655281) 71454

2012/03/21 Kerr Corporation Tytin FC Fast Set Capsules 71184

2012/03/21 71630

2012/03/21 71832

2012/03/21 DMX-Works Inc Digital Motion X-Ray System D100S, D100M 718522012/03/21 Smithys Medical ASD, Inc. Medfusion 4000 Syringe Pump 71618

2012/03/21 Roche Diagnostics Ltd. PSM Software version 2.02.02C [Model #:4944607001; Lot: version 2.02.02C] 72199

2012/03/21 71614

2012/03/21 Metrex Research Pinnacle Cure Sleeves [Model: 4511; Lot: 20008270110] 68638

2012/03/21 Capintec Inc. Radioisotope Dose Calibrator CRC 25R [Model: CRC 25R; Lot: 270333] 71594

2012/03/21 Philips Medical Systems Intellispace Portal DX 71839

2012/03/21 72009

2012/03/21 71179

2012/03/21 72044

2012/03/21 72045

CardianBCT Inc. A) Cobe Trima Blood Collection SystemB) Trima Accel LRS Platelet, Plasma, RBC SetC) Trima Accel Enhanced Platelet, Plasma, RBC SetD) Trima Accel LRS Platelet, Plasma, RBC, and TLR Filter Set

Health Canada

Liebel-Flarsheim Company A) Y Tubing Optistar/Coiled Extension TubingB) Optistar Mr. Injection SystemC) Optistar Le Contrast Delivery System

Health Canada

Health Canada

Health Canada

Health Canada

Health Canada

Philips Medical Systems (Cleveland) Inc A) Brilliance 40-64 Slice CT System-Workspace Portal; B) Brilliance 6/1016 Slice CT Sytem - Extended Brilliance Workspace Portal; C) Brilliance 40-64 Slice CT System - Extended Brilliance Workspace Portal; D) Brilliance ICT System - Extended Brilliance Workspace Portal; E) Intellispace Portal DX

Health Canada

Waverley Glen Systems - Division of Prism Medical Ltd. A) Waverley Glen Griffin Lifts equipped with the "Griffin Reacher Arm Carabiner"; B) TP Lifts equipped with the "Griffin Reacher Arm Carabiner" Health Canada


Health Canada

Cardinal Health A) Cardiac Catheterization Pack [Model: SAN30LHTGB]; B) Custom Sterile Radical Prostate Pack [Model: SOT30RPVRF] Health Canada

Health Canada

Health Canada

Health Canada

Ormco Corporation Medium Absorbent Points Model/Part no.: 16218, Affected lot number: 7200905 Health Canada

Biomerieux BV NucliSENS Magnetic Silica ref 280133 Model: 280133, Affected lot number: Z013CC1MS Health Canada

Nobel Biocare AB Nobelreplace CC RP 5.0X8MMModel: 36710Affected lot number: 462574

Health Canada

Biosite A) Triage Drugs of Abuse Plus TCA 25 Test Kit, PN 92000 Model( 92000) lot no.255830, 262143, 262838, 259628, 259954B) Triage Drugs of Abuse Plus TCA 25 Test Kit, PN 92008 Model (92008 )lot no. 259403NA

Health Canada
















2012/03/21 Philips Healthcare CIL 86100108

2012/03/21 Terumo Terumo Advanced Perfusion System 1:6” Roller Pump Occlusion Terumo AA-2011-015-C

2012/03/21 Boston Scientific Imager II Catheter (Urology) Boston Scientific 90752558-FA2012/03/21 Boston Scientific Imager II Angiographic Catheter (Peripheral Intervention) Boston Scientific 90752558 Ver AA

2012/03/23 Philips Healthcare HeartStart XL+ (861290) Defibrillator/Monitor Philips Healthcare CIL 86100109

2012/03/26 Z-1099-2012

2012/03/27 2012/003/022/081/022

2012/03/27 2012/003/019/081/012

2012/03/27 2012/002/014/601/003

2012/03/27 2012/003/016/291/006

2012/03/27 Siemens Healthcare Diagnostics, Inc MAGNETOM ESSENZA 2012/003/015/291/002

2012/03/27 The Spectranetics Corporation 12 Fr SLS II Laser Sheath [Model/Part no.: 500-001] 2012/003/015/291/016

2012/03/27 2011/007/011/601/004

2012/03/27 2012/003/020/081/004

2012/03/27 2012/003/015/291/001

2012/03/27 Diagmed Healthcare Ltd Indigo Carmin Sterile 2011/009/019/081/013

2012/03/27 2012/003/019/081/014

Philips Healthcare Philips HeartStart MRx monitor/defibrillator, Model/Part no.: M3535A, M3536A, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6

Clarity Medical Systems Inc., Pleasanton, CA Retcam3 & Retcam Shuttle with version 6.0 software.A)Model number RC3, part number 21-100500B)Model number RCS, part number 20-000300

FDA

DePuy Mitek Anchor Bone Implanted Ligament [Affected lot number: 3549274, 3549296, 3549732, 3549621,3549273, 3547740] MHRA

OptiMed GmbH AltaFlow Measuring Catheter pigtail 5F(1.67mm) x 110cm [Model no.:1080-4100; Lot number: 6000073905] MHRA

QRS Diagnostic QRS Diagnostic Universal ECG 12 Lead IEC ECG Devices [Model/Part no.: Z-7000-0400] MHRA

Ranier Technology Limited Cadisc™ -L Distractor [Model/Part no.:RTI-010-0305 (P000946); Lot number: S1008003, S1102189] MHRA

MHRA

MHRA

Venner Medical Venner™ A.P. Advance ™ Video Laryngoscope Difficult Airway Blade (DAB) [Model/Part no.: 700170;Lot number: FM10080006, FM10110007, FM11010001] MHRA

Waters Corporation ACQUITY Sample Organizer [Model/Part no.: 186015020] MHRA

Biomerieux BV BacT/ALERT® Blood Collection Adapter CapA) 279012, B) 210361 MHRA

MHRA

Ethicon Endo-Surgery ECHELON™ 60 ENDOPATH® STAPLER Endoscopic Linear Cutter (Straight) Model/Part no.: A) EC60 B) SC60 C) LONG60 Affected lot no: A) ECHELON™ 60 ENDOPATH® STAPLER Endoscopic Linear Cutter (Straight, 340mm)B) ECHELON™ 60 ENDOPATH® STAPLER Compact Endoscopic Linear Cutter (Straight, 280mm)C) ECHELON™ 60 ENDOPATH® STAPLER Long EndoscopiC Linear Cutter (Straight, 440mm)

MHRA


http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/fieldsafetynotices/CON146746











2012/03/27 Abbott Aliquoter Module connected to FlexLab 3.6 2012/003/022/081/021

2012/03/27 2012/002/007/601/003

2012/03/30 Roche Diagnostics Ltd. Elecsys 2010 Analyzer Software version 06-07 Z-1218-2012

2012/03/30 Z-0875-2012

2012/03/30 Z-0989-2012, Z-0990-2012

2012/03/30 Z-1196-2012, Z-1197-2012

2012/03/30 Smith & Nephew N.A.

MHRA

Meditech Systems Ltd 22835XMMS Bacterial / viral HME filter with X-tendable catheter mount + elbow Model no.: L30111108 MHRA

FDA

Smith & Nephew RENASYS Port Foam Dressing Kit Port [Model/Part no.: 66800694] FDA

Kerr Corporation 1) Artiste Nano-Hybrid Affected Product; 2) Flow Tec Nano-Hybrid Flowable Affected Product FDA

Philips Healthcare 1) Philips MultiDiagnost Eleva II Software Version R4.1.x Model: 708032; 2) Philips MultiDiagnost Eleva FD, Software R5.1.x Model: 708034 FDA

Smith & Nephew 560P High Definition Camera Control Unit; [Product code:72201919; Batch No. BBS1203 &BBS1450]







Major Safety Alerts in March 2012


Class II N.A.

Class II N.A.

Class II

Class II Accuray Asia Ltd

FSN

FSN


FSN N.A.


FSN N.A.

FSN

FSN N.A.

FSN Interlerad Medical Systems

FSN

FSN N.A.

FSN


NA Medtronic International Ltd

Information Update Bio-Asia







NA N.A.

NA N.A.

Type III Cannon Hong Kong

Type III

Type III Medtronic International Ltd

Type III Prism Technologies Limited

Type II N.A.

Type III

Type III


Type III

Type I Thermor Ltd.

Type II Bomimed Inc

Type II

Type II

Type II Cinncinnati Sub-Zero Products

Type II

Type II Radiometer China (RCHN)








Type II N.A.


Type II Coloplast (Hong Kong) Ltd

Type II Merck Pharmaceutical (HK) Ltd.

Type II Smith & Nephew Ltd.Type II Nobel Biocare Asia Ltd.Type II Smith & Nephew Ltd.

NA Boston Scientific

Class I B. Braun Medical Hong Kong

Class II

Class II Carl Zeiss Far East Co., Ltd

NA Terumo China (Hong Kong) Ltd.


Class II

Class II AngioDynamics Inc


FSN N.A.

FSN

FSN



FSN N.A.FSN N.A.FSN Critical Diagnostics

FSN DiaSorin Inc.

FSN Hind Wing Co. Ltd





Class I N.A.


Class II

Class II

Class II N.A.

Class II

NA

NA

FSN N.A.

FSN



FSN

FSN BrainLAB Ltd

FSN Uninet Technology LTD


FSN MDSS GmbH (Germany)

FSN MDSS GmbH (Germany)


Type III

Type III

Type III Prism Technologies Limited










Type II CaridianBCT (Hong Kong) Ltd

Type II


Type II


Type III N.A.


Type II N.A.

Type II N.A.Type II N.A.

Type I

Type II Cardinal Health

Type II Sybron Dental Specialties

Type II Capintec Inc.

Type III

Type III

Type III bioMerieux China Ltd.

Type III Nobel Biocare Asia Ltd.

Type III N.A.

Covidien Hong Kong Limited




Citicon (Hong Kong) Ltd., D & R Dental

N.A. Philips Electronic Hong Kong Ltd


NA Boston ScientificNA Boston Scientific

NA Philips Electronic Hong Kong Ltd

Class II N.A.

FSN

FSN OptiMed GmbH

FSN QRS Diagnostic

FSN Ranier Technology Limited

FSN

FSN The Spectranetics Corporation

FSN Venner Medical

FSN Waters Corporation


FSN N.A.

FSN




FSN Abbott Laboratories Ltd.

FSN N.A.

Class II

Class II Smith & Nephew Ltd.

Class II N.A.

Class II

NA Smith & Nephew Ltd.



Major Safety Alerts in February 2012


2012/02/01 Polyurethane-coated breast implants N.A.

2012/02/01 Philips Healthcare CLE11-003

2012/02/01 Abbott Molecular Inc Abbott Molecular Bar Code Scanner User's Guide Abbott Molecular Inc N.A.

2012/02/01 Cordis (a Johnson & Johnson company) Cordis S.M.A.R.T. ® CONTROL® Nitinol Stent System N.A.

2012/02/02 Maquet Critical Care AB Servo-I Ventilator System (64 87 800 E407E) 70581

2012/02/02 GE Healthcare Discovery NM/CT 670 (Mode no.: 5376204-XX / lot 21048 and 20158) 70427

2012/02/02 Toshiba Medical Systems Corporation Radrex Radiographic System - Main Unit 70422

2012/02/02 Oxoid Limited Amoxicillin + Clavulanic Acid 30ug disc 70182

2012/02/02 70421

2012/02/02 Kimberly-Clark MIC Gastro-Enteric Feeding Tube, 22F 70252

2012/02/02 66418

2012/02/02 70423

2012/02/02 Roche Diagnostics GMBH Hemoglobin A1C (HBA1C), module: 5336163190, lot: All lots 70703

2012/02/06 Novomedicus 1) The Artificial Bur Patch; 2) The Artificial Bur HypoPack Z-0919-2012 to Z-0920-2012

2012/02/06 Z-0831-2012

2012/02/06 GE Ultrasound Korea GE LOGIQ P6 Ultrasound System Z-0834-2012

2012/02/06 Chien Ti Enterprise Co., Ltd Leo 3-Wheel Scooter and Leo Scooter, Model # LEO-4B Z-0774-2012

2012/02/07 Hill-Rom NP150 viscoelastic mattress 2012/001/030/081/012

2012/02/07 2012/002/001/181/002




MHRA

Philips Healthcare TumorLOC in Brilliance CT Big Bore, Extended Brilliance Workspace (EBW), GEMINI GXL 16, GEMINI TF 16, GEMINI TF 64, GEMINI TF Big Bore


Health Canada

Health Canada

Health Canada

Health Canada

Siemens AG Axiom Aristos FX Plus ( X-Ray Tubes) [Model/Part no.: 10093864; Serial Number:1324] Health Canada

Health Canada

Greiner Bio-One Vacuette 4mL EDTA K2 Tubes [Model/Part no.: 454209; Lot number: B051111] Health Canada

Tripath Imaging, Inc. (1)BD FocalPoint Slide Profiler, module: 799-00256-XX, lot: 00178R, 00382, 00383, 00386, 0442-0445, 0451, 0453 & (2)BD FocalPoint Slide Profiler (refurbished), module: 799-00256-XX, lot: 0037R

Health Canada

Health Canada

FDA

Gulf Medical Fiberoptics, Inc. Surgical Headlight Model Numbers: GMF-H001, GMF-H100, GMF-H101, GMF-H102, GMF-H103, GMF-H104, GMF-H105, and GMF-H106 FDA

FDA

FDA

MHRA

Philips Healthcare MultiDiagnost Eleva FD, Product code: 708037, Software release: PBL 6.1.1 MHRA

http://www.mhra.gov.uk/NewsCentre/CON140879
















2012/02/07 2012/002/001/181/001

2012/02/07 Sorin Group Deutschland GmbH Sorin Group perfusion system – Pump Speed Control 2012/001/030/081/002

2012/02/07 2012/001/020/601/001

2012/02/07 Beckman Coulter UK Ltd IMMAGE® Immunochemistry Systems Rheumatoid Factor (RF) Reagent 2012/001/031/601/008

2012/02/07 Biomet Merck France SARL Vanguard ROCC-Reamer, Vanguard ROCC-Finned Punch Tower 2012/001/027/081/005

2012/02/07 Advanced Sterilization Products STERRAD®200 System 2012/001/031/081/002

2012/02/08 North American Rescue, LLC N.A.

2012/02/09 Sorin Group Deutschland GmbH Revolution Centrifugal Blood Pump with PC Coating 70430

2012/02/09 Roche Diagnostics GMBH Urisys 1800 and Process System Manager 70706

2012/02/09 Keymed Olympus Endoscopic Flushing Pump System - Irrigation Tube 70184

2012/02/09 Toshiba Medical Systems Corporation Ultimax-I X-Ray Systems 70195

2012/02/09 69144

2012/02/09 Beckman Coulter Inc. RF Latex Calibrator 70580

2012/02/09 NA

2012/02/09 Zoll Medical Corporation Pedi-Padz Reduced Energy Electrode 70567

2012/02/09 Greiner Bio-One 5ml Lithium Heparin Sep. Venous Blood Collection Tube 70122

2012/02/09 Patterson Medical Supply, Inc. Bur U-Sharp Carbide FG 70069

2012/02/10 Z-0869-2012

2012/02/10 Z-0928-2012 to Z-0929-2012

2012/02/10 Z-0964-2012

2012/02/10 Hitachi Cobas c501/ 502 laboratory analyser MDA/2012/004

Philips Healthcare MultiDiagnost Eleva II R6.1.1, product code 708036 MHRA

MHRA

Wescott Medical Limited Sae-Flo MD Extension Set with Y-Connector, Catalogue No.:WEPCA200AY, Lot: 2011-1510 MHRA

MHRA

MHRA

MHRA

FDA

Health Canada

Health Canada

Health Canada

Health Canada

Airway Surgical Appliances Ltd. A) 20-30 mm/hg below Knee ;B) 20-30 mm/hg above Knee;C) 20-30 mm/hg Pantyhose;D) 30-40 mm/hg Knee High;E) 30-40 mm/hg above Knee

Health Canada

Health Canada

Health Canada Non-Invasive Ventilation Devices (CPAP, VPAP/BiPAP) - Risk of Being Used as Life-supporting Ventilators Health Canada

Health Canada

Health Canada

Health Canada

Steris Corporation STERIS SYSTEM 1E Liquid Chemical Sterilant Processing System, Model/Part no.: Model P6500 FDA

Vision-Sciences, Inc. 1) Vision Sciences Battery Charger, Lithium Ion2) Vision Sciences Rechargeable Lithium Ion Batteries, Replacement (2) FDA

Alere San Diego Alere Cholestech LDX Analyzer, Model/Part no.: 10-004, 14-874, 14-875 FDA

MHRA







http://www.fda.gov/Safety/Recalls/ucm290639.htm#table







http://hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/prof/_2012/ventilation_nth-aah-eng.php








2012/02/13 Handheld dental X-ray units N.A.

2012/02/13 BD PrepStain Vacuum Pump BD N.A.

2012/02/13 Boston Scientific Wingspan Stent System and Gateway PTA Balloon Catheter Boston Scientific N.A.

2012/02/14 Salter Labs 7600 Bubble Humidifier, 350cc volume with 6PSI safety valve Z-0803-2012

2012/02/14 Varian VariSeed 2012/002/001/291/015

2012/02/14 Nikkiso Octo Nova® HEMOFIL TRATION DEVICE (GE-F076-00, GE-F076-10, GE-F090-00, GE-F091-00) 2012/002/007/081/002

2012/02/14 2012/002/009/081/006

2012/02/14 Ranier Technology Limited Cadisc-L total lumbar disc replacement 2012/002/006/291/013

2012/02/14 Smith & Nephew Orthopaedics Ltd SpatialFrame.com software, product code 71070401, version 4.1.1 2012/002/006/081/007

2012/02/14 Varian Medical Systems PaxScan 4336R power cable 2012/002/006/081/018

2012/02/14 CaridianBCT CaridianBCT Trima Accel® Disposable Tubing Sets 2012/002/008/081/004

2012/02/14 GE Healthcare mlBG-dilution set 2012/002/003/291/014

2012/02/14 Alcon Laboratories Ltd Alcon AcrySof® CACHET® Phakic Lens 2012/002/007/081/016

2012/02/14 Beckman Coulter UK Ltd Floor Cabinet for UniCel DxH Slidemaker Stainer Cellular Analysis System 2012/002/003/601/002

2012/02/14 Biomet UK Ltd AGC Patella Button 34mm 2012/002/002/291/0362012/02/16 NEMSCHOFF Bassinet Models: BSNT/01; BSNT/02, BSNT/03, BSNT/04 Z-0832-2012

2012/02/21 2012/002/016/081/010

2012/02/21 Varian Dual Varian Clinac® accelerators with Mark or Millennium MLC and BrainLAB m3 MLC 2012/002/015/081/005

2012/02/21 2012/002/016/291/005

2012/02/21 The Helping Hand Company Hoist Turntable Mk 6 Part number RA8330 2012/002/014/291/009

2012/02/21 Thermo Fisher Scientific Oxoid Ready Poured Plate, PO0120A, CLED Agar, Lot number 1200138. 2012/002/009/601/006

2012/02/21 2012/002/009/601/013

2012/02/21 Hospira Inc. Lifecare™ 5000 IV Pump Set [0F8259701, 0G8689701, 0P7419701] 2012/002/015/081/001

2012/02/21 2012/002/010/081/001

2012/02/21 Ropox A/S Hudson Shower bed [Article: 40-25023-XX, 40-25026-XX, 40-25029] 2012/002/001/291/0052012/02/21 Activate Ltd Corgi Class Chair 2010/003/023/401/0122012/02/21 Balt Extrusion BALTACCI Infusion Catheters 2012/002/001/291/019

FDA

FDA

MHRA

MHRA

Philips Healthcare Philips IntelliVue Patient Monitors: MP20 (M8001A), MP30 (M8002A), MP40 (M8003A), MP50 (M8004A), MP60 (M8005A), MP70 (M8007A), MP80 (M8008A), MP90 (M8010A), D80 (M8016A), MX600 (865242), MX700 (865241) MX800 (865240)

MHRA

MHRA

MHRA

MHRA

MHRA

MHRA

MHRA

MHRA

MHRAFDA

Covidien Disposable imaging device accessories, Syringe, MR w/laternal flow needle; Y Tubing, MR, with single check valve; Coiled Extension Tubing MHRA

MHRA

Vascutek Anaconda and Anaconda ONE-LOK Stent Graft Systems (Model no.: B19, B21, B23, B28, B30, B32, B34)

MHRA

MHRA

MHRA

Thermo Fisher Scientific Oxoid Ready Poured Plate, PO0152A, Mueller Hinton Agar (4mm depth), Lot number 1201920 MHRA

MHRA

Intuitive Surgical Inc Intuitive Surgical ® da Vinci S Surgical Systems [Model no.: da Vinci S® Surgical System IS 2000, da Vinci Si® Surgical System IS 3000, da Vinci Si-e® Surgical System] MHRA

MHRAMHRAMHRA

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm291373.htm;http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm291539.htm

























2012/02/21 Biosense Webster Inc Carto 3 Systems 2012/002/015/081/004

2012/02/23 Sybron Dental Specialities Buchanan Medium Pluggers N.A.

2012/02/23 Sybron Dental Specialities K3 Gutta Percha, Part No.: 825-0625 & Lot No.: 042511 N.A.

2012/02/24 Zimmer Natural-Knee II Durasul All-Poly Patella Z-0848-2012 to Z-0855-2012

2012/02/24 Beckman Coulter UK Ltd Clinical Chemistry Analyzers (AU400, AU600, AU2700 and AU5400) Z-0974-2012 to Z-0977-2012

2012/02/24 Z-0360-2012 to Z-0361-2012

2012/02/24 Allen Medical Systems, Inc. Allen C-Flex Head Positioning System [Catalog No.:A-70700 and A-70701-2] Z-0655-2012

2012/02/24 Z-0447-2012

2012/02/28 Sorin CRM SonRtip endocardial pacing lead with contractility sensor, Model/Part no.: PS55D 2012/002/023/291/005

2012/02/28 Roche Diagnostics GMBH Troponin I Elecsys cobas e, Troponin I STAT Elecsys cobas e 100 2012/002/021/291/009

2012/02/28 Roche Diagnostics GMBH cobas c-pack MULTI 2012/002/016/081/014

2012/02/28 Abbott Point of Care Inc i-STAT cTnI, BNP, and CK-MB cartridge 2012/002/021/081/006

2012/02/28 Aesculap AG/ B Braun S4 Cervical Occiput Screw Remover, S4 Cervical Occiput Screw Removal Shaft 2012/002/023/291/006

2012/02/28 Bard Limited MRI Implanted Port 2012/002/020/081/018

2012/02/28 B Braun Medical Inc. SUSI instruments (various models and lots) 2012/002/020/081/020

2012/02/28 2012/002/016/081/019

2012/02/28 2012/002/023/081/006

2012/02/28 Firm initiated N.A.

2012/02/29 Mizuho Orthopedic Systems Swivel Adapter Assembly, Headrest (Plastic) 71131

2012/02/29 71094

2012/02/29 Scottcare Corporation TeleSentry Model TS01 71132

2012/02/29 71324

2012/02/29 Immucor Inc. WBCORQC (Model/Part no.: 0066090, lot number: 236123) 70667

MHRA



FDA

FDA

Philips Medical Systems Software version 4.0 Beta 2 in1) Brilliance 64 Computed Tomography System, Model #728231 and 2) Ingenuity CT computed Tomography System, Model #728326 FDA

FDA

Biomet Microfixation, Inc. IQ SYSTEM IQ INTELLIGENT DRIVER 16.51CM (6.5")(L) RABALON, STAINLESS STEEL, GOLD PLATED FDA

MHRA

MHRA

MHRA

MHRA

MHRA

MHRA

MHRA

Biomet UK Ltd Vanguard Tibial Resection Tower & Vanguard Distal Cut Block [Model: 32-487557 & 32-487002Lot 2561334 and Lot 2561329] MHRA

GE Healthcare OEC®9800, OEC® FluoroTrak 9800 Plus & OEC® 9800MD Motorized C-arm System MHRA

Thoratec HeartMate II® Left Ventricular Assist System (HM II LVAS) Sealed Outflow Graft Short Bend Relief (Catalog No. 104692) and Thoratec HeartMate II Sealed Outflow Graft (Catalog No. 103393).

Health CanadaArrow International A) Epidural Catheterization KitB) Peripherally Inserted Central Catheter Seldinger Access Kit Health Canada

Health CanadaOrtho-Clinical Diagnostics Inc. VITROS Chemistry Products dHDL Slides (Model/Part no.: 680 1895, 680 2469) Health Canada

Health Canada





















2012/02/29 Beckman Coulter Inc. Access Hybritech Free PSA (Part no.: 37210) 67750

2012/02/29 Beckman Coulter Inc. Manual Immunoassay DHEA RIA Test Kit (Part no.: DSL-8900) 71083

2012/02/29 Beckman Coulter Inc. Flow-Set Fluorospheres (Part no.: 6607007; Lot number: 7524018F, 7524019F) 71084

2012/02/29 71089

2012/02/29 71115

2012/02/29 Alba Bioscience Limited FetalScreen II Fetal Maternal Hemorrhage Screening Test 71080

2012/02/29 Beckman Coulter, Inc. ACTIVE Aldosterone RIA 71088

2012/02/29 70426

2012/02/29 Contura International A/S Bulkamid Urethroscope 71253

2012/02/29 71169

2012/02/29 Becton Dickinson and Company BBL Lysine Iron Agar 71099

2012/02/29 71090

2012/02/29 71091

2012/02/29 70640

2012/02/29 Stryker Orthopeadics Accolade RASP Handle (Model No.: 1020-1400; Lot Number: P5E93) 70655

2012/02/29 GE Medical Systems, LLC A) VMX Mobile X-ray, B) VMX Plus Mobile X-ray Systems 70843

2012/02/29 Innovacon, Inc Innovacon Strep A Rapid Test Device (Throat Swab) 69394

2012/02/29 Agfa Healthcare N.V. Impax for Cardiology- Clinical Review Station 71095

2012/02/29 Enginivity LLC (a GE Healthcare company) Enflow IV Fluid/ Blood Warming System 71100

Health Canada

Health Canada

Health Canada

Siemens Healthcare Diagnostics A) Rapidpoint 400 System B) 850/855 Blood Gas System - Control Reagents C) 840-845 Blood Gas System - Control Reagents D) 348 System - Reagents E) 860-865 Blood Gas System - Control Reagents F) RapidQC Complete Level 1 G) RapidQC Complete Level 3

Health Canada

Life Technologies Corporation (Invitrogen) A) Invitrogen CW High Res Unitray SSP Kits B) Invitrogen Allset Gold SSP CW High Res Kits Health Canada

Health Canada

Health Canada

Beckman Coulter, Inc. A) Access Immunoassay System Access Accutni ReagentB) Unicel DXI 600 Access Accutni ReagentC) Unicel DXI 800 Access Acuutni Reagent

Health Canada

Health CanadaRoche Diagnostics GMBH A) Tina-Quant IGG Gen2B) Tina-Quant IGG Gen2 Health Canada

Health Canada

Siemens Healthcare Diagnostics Products Limited A) Immulite System CK-MB AssayB) Immulite 2500 System CK-MB AssayC) Immulite System Turbo CK-MB AssayD) Immulite 2000 System CK-MB Assay

Health Canada

Siemens Healthcare Diagnostics Inc. A) 850-855 Blood Gas System - Control ReagentsB) 840-845 Blood Gas System - Control ReagentsC) 348 System - ReagentsD) 860-865 Blood Gas System - Control ReagentsE) CVM Controls

Health Canada

HowMedica Osteonics Corporation Partnership Definition PM Hip Stem - Cemented (Model No.: 6265-3-101, 6265-3-102, 6265-3-103, 6265-3-104, 6265-3-105, 6265-3-106, 6265-3-107)

Health Canada

Health Canada

Health Canada

Health Canada

Health Canada

Health Canada




















2012/02/29 Haag-Streit, AG Octopus 900 Basic, Octopus 900 Pro 68860

2012/02/29 Beckman Coulter, Inc Coulter PrepPlus 71085

Health Canada

Health Canada



Major Safety Alerts in February 2012


News N.A.

NA

NA N.A.

NA

Type II MAQUET Hong Kong Limited

Type II

Type III

Type II

Type II

Type II

Type II Mekim Ltd

Type III

Type III

Class II N.A.

Class II N.A.

Class II

Class II Chien Ti Enterprise Co., Ltd

FSN N.A.

FSN




Sanko Medical Systems (HK) LTD



Kimberly-Clark (Hong Kong) Limited

Becton Dickinson Asia Limited (BD)




FSN


FSN Wescott Medical Ltd


FSN N.A.

FSN


Type III IntegMed Limited

Type III

Type III

Type III

Type III N.A.


N.A.

Type II

Type II Mekim Ltd

Type II Patterson Medical Supply, Inc.

Class II Swedish Trading Co. Ltd.

Class II N.A.

Class II N.A.

MDA




Olympus Hong Kong and China Ltd


Advisory to Health Professionals

Suburfarm Investment & Trading Co., Ltd.


N.A.

NA BD

NA Synapse Therapeutic Ltd.

Class I N.A.

FSN


FSN

FSN Ranier Technology Limited


FSN

FSN CaridianBCT (Hong Kong) Ltd

FSN

FSN Alcon Hong Kong, Ltd.


FSN N.A.Class I N.A.

FSN Tyco Healthcare (HKSAR) Ltd

FSN

FSN Keymax Technology (HK) Ltd.

FSN N.A.



FSN Hospira Limited

FSN Chindex

FSN Ropox A/SFSN N.A.FSN N.A.

Press Release/MedWatch






FSN

FSN N.A.

FSN Citicon (Hong Kong) Ltd

Class II

Class II Beckman Coulter Hong Kong Ltd

Class II

Class II Allen Medical Systems, Inc.

Class II N.A.

FSN Innotronik Hong Kong Limited

FSN

FSN

FSN

FSN N.A.

FSN Senrex International Ltd.

FSN B. Braun Medical Hong Kong

FSN N.A.

FSN

FSN Transmedic China Limited

Type II Keymax Technologies

Type II Cemma Enterprise Co., Ltd

Type II N.A.


Type III Uninet Technology Ltd.











Type III

Type III Invitrogen Hong Kong Limited

Type III Alba Bioscience Limited



Type III Contura International A/S

Type III

Type III BD

Type III

Type III



Type II

Type II N.A.

Type II AGFA Hong Kong Limited

Type II







Type II The VITA CO. Ltd.


Major Safety Alerts in January 2012


2012/01/03 2011/012/021/081/012

2012/01/03 Beckman Coulter SYNCHRON System(s) Multi Calibrator Diskette (Ref No: 442648; Lot No: M002642G) 2011/012/020/601/008

2012/01/03 GE Healthcare Definium 8000 and Discovery XR650 Patient Barrier (Ref: FMI 10856) 2011/012/021/081/014

2012/01/03 GE Healthcare GE OEC Fluorostar 7900 (Ref: FMI 15116) 2011/012/022/081/013

2012/01/03 HeartWare Inc HeartWare Ventricular Assist System 2011/012/007/081/021

2012/01/03 Karl Storz Endoscopy (UK) Ltd Single-Use Gas Filter 031122-25 2011/011/022/291/001

2012/01/03 Maquet Cardiovascular MAQUET HANAULUX G8 2011/012/021/081/018

2012/01/03 Spacelabs Healthcare Inc Ultraview SL Command Module 2011/012/019/081/002

2012/01/03 St. Jude Medical Eon™ (Model 65-3716), Eon Mini™ (Model 65-3788) and Brio™ (Model 65-6788) 2011/012/019/081/010

2012/01/03 Stryker Orthopaedics X-Change III Connector 0943-5-000 2011/011/008/291/0132012/01/03 Stryker Orthopaedics TRIDENT 10 Degree Poly Inserts 2011/011/008/291/0222012/01/03 SynCardia Systems, Inc. Freedom Driver System 595000-001 2011/012/019/291/002

2012/01/03 2011/012/020/081/023

2012/01/03 OptiMed GmbH Cemento Plus 2011/012/013/081/007

2012/01/03 Philips Healthcare GEMINI TF 16 and GEMINI TF 64 PET/CT Systems Software Versions 3.5.1 and 3.5.1.1 2011/008/031/401/008

2012/01/03 RMS UK RES-Q-VAC Suction Unit with FSP (Bacteria) Fileter and Soft Yankauer 2011/010/025/081/002

2012/01/03 2011/012/015/291/021

2012/01/03 Siemens Healthcare Diagnostics Ltd CLiNITEK Status System 2011/012/016/601/001

2012/01/03 Thermo Fisher Scientific Oxoid M.I.C Evaluator Strips, Teicoplanin (MA0118) 2011/012/021/601/002

2012/01/03 2011/001/025/081/023

2012/01/03 2011/012/019/601/001




Biomet Orthopedics Discovery Elbow System Humeral Condyle Kit- Hexalobular [Part No: 114700; Lot No: 797550] MHRA

MHRA

MHRA

MHRA

MHRA

MHRA

MHRA

MHRA

MHRA

MHRAMHRAMHRA

Microgenics Corporation (Thermo Fisher Scientific) CardioImmune XL Cardiac Marker Control, Level L, Level 1, Level 2, Level 3, Multi-pack, Sample Pack. MHRA

MHRA

MHRA

MHRARoche Diagnostics GmbH COBAS® TaqMan® HIV-1 Test, version 2.0 for use with the High Pure System, CE-IVD MHRA

MHRA

MHRA

Thomas Medical Products Thomas Medical Products: 1) 7F SafeSheath Tearaway Kit – 13cm; 2) 9F SafeSheath Tearaway Kit – 13cm; 3) Transvalvular Insertion Tool Kit; 4) SafeSheath® Sealing Adapter Kit; 5) SafeSheath® Sealing Adapter Kit with Wing Extension Kit MHRA

TRUMPF Medical Systems Sterilisable Handle ALC in Surgical lighting systems iLED and TruLight (Material number: 1583966) MHRA






















2012/01/03 Varian Varian Treatment versions 6.6.5034, 6.6.5042, 6.6.5046, 6.6.5048, 6.6.5051 and 6.6.5052 2011/012/013/081/004

2012/01/05 2011/012/022/291/004

2012/01/05 Siemens Healthcare Diagnostics Ltd Dimension Vista® Software Version 3.4 2011/012/021/601/003

2012/01/05 Ikaria Ikaria INOmax DS Drug Delivery System N.A.2012/01/06 Wallac PerkinElmer Genetic Screening Processor (GSP 2021-0010) Z-0603-20122012/01/10 Columbia Medical Ultimate Bath Chair H88489, H88519 and H88521 2010/005/021/401/008

2012/01/10 2011/009/016/401/011

2012/01/10 QIAGEN GmbH 8-Rod Covers (Lot No. CH_1104624 and CH_1105182) 2011/012/020/081/013

2012/01/10 2012/001/005/121/012

2012/01/10 SynCardia Systems, Inc. SynCardia Companion 2 Driver System 2011/012/022/081/009

2012/01/10 2011/006/027/601/001

2012/01/10 DiaMed GmBH IH-1000 [Product REF: 001000V; Software version: 01.03.04] 2011/012/030/081/002

2012/01/10 2012/001/005/181/004

2012/01/10 Haemonetics Corporation Haemonetics cardioPAT® 2011/009/009/081/011

2012/01/10 Johnson & Johnson Medical Ltd ACUVUE® OASYS® (senofilcon A) Brand Contact Lenses 2011/012/030/081/003

2012/01/10 Instrumentation Lab (UK) Ltd ACL TOP® Family 2011/011/030/401/006

2012/01/10 2011/010/021/081/014

2012/01/12 Professional Disposables International PDI Electrode Prep Pads in Spacelabs Hook-up kits Z-0262-2012

2012/01/12 PerMedics, Inc. Odyssey A radiation treatment planning system (Versions 4.4 through 4.7) Z-0345-2012

2012/01/12 Midmark Corp Midmark M11 Ultra Steam Sterilizer Z-0597-2012

2012/01/12 Z-0644-2012, Z-0645-2012, Z-0646-2012

2012/01/12 Spacelabs Healthcare Lifescreen ECG Screening System V3 Z-0520-2012

2012/01/12 Given Image Bravo® pH Monitoring System, part number FGS‐0312 (5‐Pak) or FGS‐0313 (Singles) Firm initiated N.A.

2012/01/13 Respironics Inc Respironics Trilogy 100 ventilators N.A.

2012/01/13 Firm initiated AA-2011-013-C

2012/01/13 Covidien PTE Ltd DUET TRS Universal Straight and Articulating Single Use Loading Units (SULU) Firm initiated N.A.

2012/01/17 Stryker Orthopaedics Acetabular Reamer 44mm (Catalogue no. 2102-0444) 2012/001/011/081/0102012/01/17 Stryker Orthopaedics XIA 3 ANTI TORQUE KEY (Catalogue no. 48237026) 2012/001/005/121/004

MHRA

Philips Healthcare All Brilliance CT Big Bore systems having the software versions 3.5.0.17401 and 3.5.1.17002 MHRA

MHRA

FDAFDA

MHRA

Oridion Medical Surestream CO2 Sampling Lines: SureLine Adult, SureLine Pediatric, SureVentLine, Sure VentLine H Set, SureLine O2 Adult (Part Numbers 010976, 010977, 010986, 010987, 010979) MHRA

MHRASybron Dental Specialities Vector TAS Modular Driver (601-0007) and Vector TAS Kit (includes 1 Vector TAS Modular Driver) (601-0010) MHRA

MHRAArjoHuntleigh Lifeguard® LG20 and LG50 patient trolleys (stretchers) ; [Serial Numbers: P064867 to P100186 inclusive] MHRA

MHRADePuy International Ltd DePuy Universal Femoral Sleeve Distal Porous 34 MM [Model No.: 129453225; Lot numbers: 115369 and 115369A] MHRA

MHRA

MHRA

MHRANewdeal Integra Life Pre-Amp Transducer Cable for the Camino® Advanced Monitor (CAM01) and the Multi-Parameter Monitor (MPM1) Part Number: PAC1 MHRA

FDA

FDA

FDA

Siemens Healthcare Diagnostics, Inc (1) Dimension(R) Vista(R) V-LYTE(R) Standard A (K820), (2) Dimension(R) Vista(R) V-LYTE(R) Standard B/Salt Bridge (K825), (3) Dimension(R) Vista(R) V-LYTE(R) Diluent (K835)

FDA

FDA

FDATerumo CVS Modified cable to connect the system to an occluder for the Sarns Modular Perfusion System 8000

MHRAMHRA























http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm287575.htm;%20http://www.fda.gov/MedicalDevices/Safety/RecallsCorrectionsRemovals/ListofRecalls/ucm287528.htm



2012/01/17 Leica Primary antibodies to CD4 (clone1F6), CD7 (clone LP15), Estrogen Receptor (clone 6F11) 2012/001/010/601/008

2012/01/17 Natus Medical Incorporated ABaer® Hearing Screener with software version 5.0.17 or lower 2012/001/010/081/016

2012/01/17 2012/001/010/081/008

2012/01/17 Cefndy Healthcare (Rhyl) Cefndy Healthcare X220 & X221 (including X312 & X313) Bariatric Commodes 2009/011/017/081/018

2012/01/17 2011/012/005/081/001

2012/01/17 2010/007/005/401/002

2012/01/17 Abbott ARCHITECT Active-B12 (Holotranscobalamin) 2012/001/006/601/0012012/01/17 Alere Triage® 8 Panel for Drugs of Abuse Test Kit 2012/001/012/081/0022012/01/17 Axis-Shield poC AS Afinion™ CRP (REF 1115013 and 1115014) 2012/001/010/081/010

2012/01/19 Agfa Corp. Agfa Computed Radiography Systems with DX-G Digitizer Z-0591-2012

2012/01/19 from Z-0629-2012 to Z-0635-2012

2012/01/19 Biomet Inc. Biomet Series A Thin Patella, Standard Patella, and Asymmetrical Patella from Z-0695-2012 to Z-0704-2012

2012/01/19 GE Healthcare Ge LOGIQ E9 Diagnostic Ultrasound Systems running software versions R3.1.0 and R3.1.1. Z-0705-2012

2012/01/19 Philips Medical Systems (Cleveland) Inc. SKYlight Imaging Systems, Model 882050 Z-0607-2012

2012/01/20 Siemens Healthcare Diagnostics Dade Actin FSL Activated PTT Reagent (Model no. B4219-1, B4219-2) 70183

2012/01/20 GE Healthcare Patient Data Module (Model no. PDM-XXX-XXX-XXXX) 69525

2012/01/20 Ethicon Endo-Surgery Endopath ETS45 Endoscopic Linear Cutter (Model no. ETS45) 69531

2012/01/20 Seradyn Inc. Tobramycin Calibrators (Model no. 7F93-01) 69168

2012/01/20 69529\

2012/01/20 Sorin Group Italia S.R.L. Cardiovascular Oxygenator Custom Packs 69942

2012/01/20 Siemens AG Mevatron Linear Accelerator 69949

2012/01/20 Philips Medical Systems (Cleveland) Inc. Skylight Gamma Camera System (2160-3000A) 69952

2012/01/20 Beckman Coulter Coulter ACT 5diff Fix Reagent (8547171) 70194

MHRA

MHRA

NIHON KOHDEN NIHON KOHDEN Amp Units (JB-116B and JB-132B and Extension Unit MS-110B) used for Neuromaster MEE-1000A MHRA

MHRA

Fisher and Paykel Healthcare Ltd Fisher & Paykel Healthcare PT100 (myAIRVO) & PT101 (AIRVO) units [Part no.: PT100UK & PT101UK; Affected lot number: 080101-110420] MHRA

Karomed Ltd Karomed’s static mattresses and overlays [Product Model: Transfoam, Transvisco, Transwave Supreme and Transvalue mattresses and the Transvisco and Transpad overlay] MHRA

MHRAMHRAMHRA

FDA

ConMed Corp. STAT2 I.V. Controller, Extension Set Gravity Flow Controller, Primary Administration Set Gravity Flow Controller, Secondary Set Gravity Flow Controller FDA

FDA

FDA

FDA

Health Canada

Health Canada

Health Canada

Health Canada

Baxter Healthcare SA A) Acute Renal Dialysis Machine Aquarius System (Model no. GEF09700);B) Acute Renal Dialysis Machine Aquarius System - Platinum Software (Model no. GEF08200) Health Canada

Health Canada

Health Canada

Health Canada

Health Canada
























2012/01/20 Coopersurgical Inc Tis-U-Trap with Cannula-Curette 70263

2012/01/20 67751

2012/01/20 70181

2012/01/20 Toshiba Medical Systems Corporation RADEX-1 70234

2012/01/20 70082

2012/01/20 69661

2012/01/20 Siemens AG Artis Zee Multi-Purpose [Model No.: 10094139; Serial Number 157633] 70411

2012/01/20 HowMedica Osteonics Corporation Triathlon Mobile Bearing Knee Surgical Protocol 69276

2012/01/20 69647

2012/01/20 69651

2012/01/21 N.A.

2012/01/26 2012/001/013/291/009

2012/01/26 Beckman Coulter UK Ltd Active Renin IRMA Test Kit DSL-25100 2012/001/017/601/002

2012/01/26 Biomet UK Ltd Oxford revision stem 2012/001/017/081/011

Health CanadaBeckman Coulter Inc. Access Total T3 Reagent Health Canada

Ortho-Clinical Diagnostics Inc. Vistros Chemistry Products IGM Reagent and Vistros Chemistry Products Vanc Reagent Health Canada

Health Canada

Roche Diagnostics GMBH Online TDM Theophylline (HIT. 911, 912, 917 and MOD.P.) and Cobas Integra Theophylline for Cobas C Systems Health Canada

Biomet Microfixation, Inc. Sternalock Blu Implant Tray [Model No.: 73-1300, 73-1301, 73-1302; Lot No.: 032211, 042911, 100611, 249640, 280130, 280131, 312560, 031411, 011411] Health Canada

Health Canada

Health Canada

Sorin Group Italia S.R.L. A) Ecc. O. Integrated Mini Bypass System with Preconnected TubingB) Primo2x Oxygenator w Intergrated Hardshell Venous ReservoirC) Synthesis Oxygenator w Heat Exchanger Arterial Filter and Venous ReservoirD) D903 Avant 2 Adult Hollow Fiber OxygenatorE) Synergy Adult Intergrated Mini Bypass SystemF) D905 EOS Pediatric Hollow Fiber OxygenatorG) D905 Module Pediatric Hollow Fiber OxygenatorH) Apex HP Phisio Smart Hollow Fiber Membrane Oxygenator I) D903 Oxygenator Perfusion Tubing Pack Phisio or Non Phisio Coated w OxygenatorJ) Primo2X Oxygenator Perfusion Tubing Pack Phisio or Non Phisio Coated w OxygenatorK) Synthesis Oxygenator Perfusion Tubing Pack Phisio or Non Phisio Coated w OxygenatorL) Synthesis Oxygenator Perfusion Tubing Pack Phisio Coated w OxygenatorM) D901 Oxygenator Perfusion Tubing Pack Phisio Coated w OxygenatorN) D902 Oxygenator Perfusion Tubing Pack Phisio Coated w OxygenatorO) D905 EOS Oxygenator Perfusion Tubing Pack Phisio Coated w Oxygenator

Health Canada

Integra Lifesciences Corporation DBA Integra Lifesciences Non-Sterile Step Down Connector [Model No.: NL8600401] Health Canada

Carefusion Nicolet® Cortical Stimulator Control Unit, Nicolet® C64 Stimulus Switching Unit (SSU) Amplifier and NicoletOne Software with Cortical Stimulator License FDA

Varian Eclipse Release 10 with ARIA™ Radiation Oncology (RT Chart module) Release 10 (Client Build 10.0.28 or Build 10.0.34) MHRA

MHRA

MHRA















2012/01/26 2012/001/017/081/002

2012/01/26 2012/001/018/291/004

2012/01/26 Stryker Osteosynthesis T2 Arthrodesis Nail (left and right version) 2012/001/016/081/0182012/01/26 Transonic Systems Inc COstatus AV Loop [Model/Part no.: HCS3011] 2012/001/017/081/020

2012/01/30 Z-0390-2012

2012/01/30 Z-0516-2012

2012/01/30 ICU Medical, Inc Orbit and Orbit Micro Subcutaneous infusion set and IV Start Kits Convenience kit Z-0592-2012, Z-0593-2012

2012/01/30 Carefusion NicVue Software version 2.9.2 and 3.0.1 Z-0737-2012

2012/01/31 Radiometer Medical APS ABL80 FLEX Analyzers configured with either FLEX or BASIC software 2012/001/025/291/001

2012/01/31 Siemens Healthcare Diagnostics Syringes for BEP® III 2012/001/020/601/009

2012/01/31 Leica Primary antibodies to CD2 (clone 11F11) and CD7 (clone LP15) 2012/001/026/601/002

2012/01/31 2011/010/010/081/013

2012/01/31 COMINOX s r l Strerilclave 6B Speedy 2011/007/025/291/0302012/01/31 Elekta XVI R4.5 and R4.6 without iGuide ® 2012/001/025/291/002

2012/01/31 2012/001/023/081/010

2012/01/31 2012/001/017/081/018

2012/01/31 Beckman Coulter UK Ltd AU2700/AU2700 Plus & AU5400 Clinical Chemistry Analyzers 2012/001/024/601/006

2012/01/31 2012/001/023/081/008

Coloplast A/S Connectable Radio-Opaque Pusher CH/FR 07/ 40cm REF YN2867 included in various kits-mainly ureteral stents MHRA

Smith & Nephew Orthopaedics Ltd Smith & Nephew Endoscopy Dyonics Power ll Control Unit (Product code:72200873) MHRA

MHRAMHRA

Henry Schein, Inc. a) Maxcem Elite(TM) self-etch/self-adhesive resin cement, Refill Kit, net wt. 10 g, REF/Part # 33872; b) CLEAR --- Refill Kit Contents: 2 Syringes (5 g ea), 10 Automix tips (regular) 4:1, 10 Automix tips (wide) 4:1, 10 Intra-oral tips Dental resin cement. FDA

Varian Portal Vision, R-Arm with 4D Integrated Treatment Console [Model/Part no.: H80, H81] FDA

FDA

FDA

MHRA

MHRA

MHRAColoplast A/S Speedicath Compact CH10 female catheters [Model/Part no.: 285800; Affected lot number: 2846651] MHRA

MHRAMHRA

Cardiac Science Powerheart 9300A, 9300E, 9300P, 9390A, and 9390E; CardioVive 92532 and 92533 (manufactured between July 1, 2011 and December 30, 2011) MHRA

Adin Dental Implant Systems Ltd Retaining Screw for TMATM WP/RP/NP Trans Mucosal Abutment System 3mm MHRA

MHRA

Biomet 3i Certain® Low Profile 17ﾟAngled Abutment MHRA



















Major Safety Alerts in January 2012


FSN N.A.


FSN

FSN

FSN HeartWare Inc

FSN

FSN MAQUET Hong Kong Limited


FSN

FSN Stryker China LtdFSN Stryker China LtdFSN N.A.


FSN N.A.


FSN N.A.

FSN

FSN


FSN

FSN N.A.



KARL STORZ Endoscopy China Hong Kong office





FSN


FSN

Class I N.A.Class II N.A.

FSN N.A.

FSN N.A.

FSN N.A.

FSN N.A.

FSN N.A.


FSN Bio-Rad Pacific Ltd.

FSN

FSN

FSN

FSN Vastec Medical Limited

FSN N.A.

Class II N.A.

Class II N.A.

Class II

Class II

Class II Schmidt Bio Med Tech (H.K.)

NA

Class I Celki Medical Company



FSN Stryker China LtdFSN Stryker China Ltd




Haemonetics (Hong Kong) Limited


Associated Medical Supplies Company, Ltd.


Given Imaging (Asia) Company Ltd.

FSN Leica Microsystems Ltd.

FSN N.A.

FSN N.A.

FSN Cefndy Healthcare (Rhyl)

FSN

FSN Karomed Ltd

FSN Abbott Laboratories Ltd.FSN N.A.FSN N.A.

Class II AGFA Hong Kong Limited

Class II Goodmark Medical Supplies Ltd

Class II N.A.

Class II


Type II

Type III

Type III

Type III Thermo Fisher Scientific (HK)

Type III Baxter Healthcare Ltd

Type II Innotronik Hong Kong Limited

Type II



Fisher & Paykel Healthcare Limited






Type II Anchor Medical Services



Type III

Type III

Type I N.A.

Type I


Type II Innotronik Hong Kong Limited

Type II Milverton Limited

Type I CareFusion Hong Kong Ltd.

FSN


FSN N.A.





FSN Coloplast (Hong Kong) Ltd


FSN Stryker China LtdFSN Transonic Systems Inc

Class II Henry Schein, Inc.

Class II

Class II N.A.

Class II CareFusion Hong Kong Ltd.

FSN Radiometer China (RCHN)

FSN

FSN Leica Microsystems Ltd.

FSN Coloplast (Hong Kong) Ltd

FSN COMINOX s r lFSN Elekta Ltd

FSN Pacific Medical Systems Ltd

FSN N.A.


FSN Ositek (HK), Inc. Ltd



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