Monthly Summary of Medical Device Safety Alerts - January 2009

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

Description of ProductSource of

Information*Reference No. by Source

Alert Type by

Source

Date of Issue

(YYYY/MM/DD)Local Agent

Terumo Advanced Perfusion System 1 (Model 801763 and 801764) FDA Z-0445-2009 to Z-0446-2009 Class II 2-Jan-09 TERUMO CHINA (H.K.) LTD.

CTS (Guidant Cardiac Surgery) VASOVIEW 4 Endoscopic Vessel Harvesting System

with VASOVIEW Flexible Endoscopic ToolsFDA Z-0476-2009 Class II 2-Jan-09 Boston Scientific Hong Kong Ltd

FHC microTargeting Platform DBS Measuring Fixture (Cataog # 66-FA-SF) FDA Z-0486-2009 Class II 2-Jan-09 N.A.

Smiths Medical Wallace Oocyte Recovery Needles, Oocyte Recovery sets (Product

no. ONS1633LL-750 and ONS1733LL-750)FDA Z-0593-2009 Class II 2-Jan-09 Gold Pacific Enterprises

SiemensIMMULITE/IMMULITE 1000 Progesterone (LKPG 1,5) FDA Z-0524-2009 Class II 2-Jan-09 Siemens Healthcare Diagnostic Limited

Enterix Insure Quik Fit Developer Kit (Product no 30025 and 50025) FDA Z-0480-2009 Class II 2-Jan-09 N.A.

Qualigen FastPack Total PSA Immunoassay (Catalog# 25000001) FDA Z-0500-2009 Class II 2-Jan-09 N.A.

Stryker Stair Chairs Stair-PRO 6251, Stair-PRO 6252, Evacuation Chair Model 6253 MHRA 2008/011/028/061/020 FSN 7-Jan-09 Stryker China Ltd

Johnson and Johnson ENDOPATH® Electrosurgery Probe Plus II MHRA 2008/012/009/061/007 FSN 7-Jan-09 Johnson & Johnson Medical (HK)

ArthroCare Saber 30 with Integrated Cable Wand MHRA 2008/012/009/061/003 FSN 8-Jan-09 N.A.

EV3 Marathon Flow Directed Micro Catheter Catalog Number 105-5055 MHRA 2008/012/009/061/015 FSN 8-Jan-09 N.A.

GE Centricity Ultra Laboratory System Software FDA Z-0472-2009 Class II 8-Jan-09 GE Medical Systems Hong Kong Ltd.

Siemens KinetDx 4.2 Workplace and syngo Dynamics Workplace FDA Z-0543-2009 to Z-0545-2009 Class II 8-Jan-09 Siemens Healthcare Diagnostic Limited

Alphatec Spine Novel PEEK VBR XS FDA Z-0507-2009 to Z-0508-2009 Class II 8-Jan-09 N.A.

Cordis MassTRANSIT Infusion Catheter Kit, 605-731K & 605-780K FDA Z-0604-2009 Class II 8-Jan-09 N.A.

Stryker Leibinger New Generation/Universal Mandibular System FDA Z-0610-2009 Class II 8-Jan-09 Stryker China Ltd

Sunrise Medical DeVilbiss Model 515A Oxygen Concentrator FDA Z-0617-2009 Class II 8-Jan-09 N.A.

CovaTec Flexi-Seal Fecal Management System Advanced Odor Control Kit. Rx only FDA Z-0618-2008 Class II 8-Jan-09 N.A.

Edwards Lifesciences EndoClamp aortic catheter FDA Z-0644-2009 to Z-0645-2009 Class II 8-Jan-09 N.A.

Hyphen BioMed Biophen Heparin 6 (various lots) MHRA 2008/012/003/061/001 FSN 9-Jan-09 N.A.

Siemens ADVIA Centaur HIV 1/O/2 Enhanced (EHIV) Assay MHRA 2008/012/023/051/001 FSN 9-Jan-09 Siemens Healthcare Diagnostic Limited

Arcomedical Infusion Syramed SP6000 Syringe Pumps MHRA 2008/011/005/601/004 FSN 9-Jan-09 N.A.

Boston Scientific Safety and Standard Push PEG Kits

Boston

Scientific

Hong Kong

Ltd

N.A.Firm Initiated

Field Action13-Jan-09 Boston Scientific Hong Kong Ltd

Zimmer NexGen® Complete Knee Solution Provisional Articular Surface MHRA 2008/012/016/061/007 FSN 14-Jan-09 Zimmer PTE Ltd. (Hong Kong branch)

ThermoFisher BO0366G Brain heart infusion, lot number 1070312 MHRA 2008/012/015/601/005 FSN 14-Jan-09 N.A.

GE OEC 9900 Elite ESP Fluoroscopic x-Ray System and GSP Fluoroscopic x-Ray

SystemFDA Z-0341-2009 to Z-0342-2009 Class II 14-Jan-09 GE Medical Systems Hong Kong Ltd.

Rockwell Medical SteriLyte Liquid Bicarbinate, Formula CL-02 and RL-01 FDA Z-0439-2009 to Z-0440-2009 Class II 14-Jan-09 N.A.

Innovative Implant Sinu-Lift System (Model SLS-1) FDA Z-0505-2009 Class II 14-Jan-09 N.A.

Biomet Compress Instrument Anchor Plug Holders FDA Z-0517-2009 to Z-0521-2009 Class II 14-Jan-09 N.A.

Hill-Rom Synergy Pulse, Synergy Dynamic, Synergy Air Squared and Pro 2000 FDA Z-0600-2009 to Z-0603-2009 Class II 14-Jan-09 N.A.

Roche Diagnostics ISE Internal Standard Gen 2 (Catalog no 04522320190) FDA Z-0542-2009 Class II 14-Jan-09 Roche Diagnostics (Hong Kong) Ltd

GE Solar 8000M System FDA Z-0285-2009 Class II 14-Jan-09 GE Medical Systems Hong Kong Ltd.

Medical Device Control Office

Department of Health

The Government of HKSAR1

http://www.fda.gov/bbs/topics/ENFORCE/2008/ENF01088.html







http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/FieldSafetyNoticesformedicaldevices/CON035979
























Siemens CT syngo Dual Energy Viewer (Model 10094833) FDA Z-0647-2009 Class II 14-Jan-09 Siemens Healthcare Diagnostic Limited

Hitachi CXR4 Computed Tomography Scanner FDA Z-0608-2009 Class II 14-Jan-09 N.A.

ACIST CVi Angiographic Injection System (Model: CVi Toshiba interface Cable) FDA Z-0643-2009 Class II 14-Jan-09 N.A.

Diamedix Measles IgG Enzyme Immunoassay Test Kit (DIAMEDIX) FDA Z-0607-2009 Class II 14-Jan-09 N.A.

Zimmer Natural-Knee II System Modular Cemented Tibial Baseplate (Ref 6420-01-

230)FDA Z-0871-2009 Class II 14-Jan-09 Zimmer PTE Ltd. (Hong Kong branch)

Frontier Medical Repose Mattress and Cushion MHRA 2008/009/015/301/001 FSN 15-Jan-09 N.A.

Boston Scientific Stonetome Single-Use Stone Removal Device

Boston

Scientific

Hong Kong

Ltd

N.A.Firm Initiated

Field Action15-Jan-09 Boston Scientific Hong Kong Ltd

Stryker Intouch Bed Model 2130 with positionpro (model: 2130-000-000), Intouch Bed

Model 2140 with Positionpro (model: 2140-000-000)Health Canada 45354 Type II 15-Jan-09 Stryker China Ltd

Biomet Microfixation A) Lactosorb Endobrow Lift Complete, B) Office Fixation Kit, C)

1.5/IMF Small Office SetHealth Canada 43740 Type II 15-Jan-09 N.A.

Toshiba Aquilion One (TSX-310A/2) Health Canada 44879 Type II 15-Jan-09 Sanko Medical Systems (HK) LTD

Invacare Careguard Mattress Health Canada 45093 Type II 15-Jan-09 Direct Health LTD

Medtronic DLP Pericardial / Intracardiac Sump Health Canada 45468 Type II 15-Jan-09 Medtronic International, Ltd.

Philips Easydiagnost Eleva Health Canada 45433 Type II 15-Jan-09 Philips Health Care (Great China)

Convatec Flexi-Seal FMS Advanced Odor Control Health Canada 45051 Type II 15-Jan-09 Bristol-Myers Squibb (HK) LTD.

KCI Kinair IV Health Canada 45500 Type II 15-Jan-09 N.A.

Maquet Maquet Foot Paddle Health Canada 44983 Type II 15-Jan-09 Maquet Hong Kong LTD.

Philips Multi Diagnostic Eleva-Flat Detector-IM Health Canada 44908 Type II 15-Jan-09 Philips Health Care (Great China)

Stryker Patient Registration Mask (Box of 5) Health Canada 45115 Type II 15-Jan-09 Stryker China Ltd

Coloplast Philips Bougle Health Canada 45314 Type II 15-Jan-09 Coloplast (HK) LTD

Roche Diagnostics Process System Manager Health Canada 44820 Type II 15-Jan-09 Roche Diagnostics (Hong Kong) Ltd

Smith & Nephew Reflection Hip PE Inlay (7174-0250) Health Canada 45263 Type II 15-Jan-09 Smith & Nephew LTD

Synthes (Canada) Synfix LR, Low Profile U-Joint Driver Health Canada 45120 Type II 15-Jan-09 Synthes International Ltd.

KCI Therapulse ATP Health Canada 44999 Type II 15-Jan-09 N.A.

Biomerieux Vitek 2 GN Card Health Canada 44650 Type II 15-Jan-09 Biomerieux China Ltd. (HK office)

Abbott Voyager RX Coronary Dilation Catheter (1011759-08, 1011759-12) Health Canada 44757 Type II 15-Jan-09 Abbott Laboratories LTD.

Philips A) Allura XER FD10/10, B) Allura XPER FD20/10 System, C) Integris H5000C

Cardiology Imaging System (722016), D) Integris Allura (722043*), E) Allura XPER

FD10, F) Allura XPER FD20 System

Health Canada 44817 Type II 15-Jan-09 Philips Health Care (Great China)

Philips A) Allura XPER FD20/10 System, B) Integris H5000C Cardiology Imaging

System (722016), C) Integris Allura (722043*), D) Allura XPER FD10, E) Allura XPER

FD20 System

Health Canada 45310 Type II 15-Jan-09 Philips Health Care (Great China)

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

Care Bed Model 2140 (2140-000-000)Health Canada 45351 Type II 15-Jan-09 Stryker China Ltd

St Jude Medical Epicor LP Connecting Cable MHRA 2008/012/010/061/001 FSN 20-Jan-09 N.A.

BioMerieux Vironostika HIV Uni-Form II Ag/Ab MHRA 2008/011/019/061/001 FSN 20-Jan-09 Biomerieux China Ltd. (HK office)

Owen MumfordAutopen Classic 3ml, 1 unit (1-21 units) MHRA 2008/010/002/401/007 FSN 20-Jan-09 N.A.










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
























Siemens ADVlA Centaur, Centaur CP and Centaur XP, iPTH assay MHRA 2008/012/001/061/004 FSN 20-Jan-09 Siemens Healthcare Diagnostic Limited

Biomet Sterile 1/3 Tubular Plates (85 mm x 7 Holes) MHRA 2008/012/002/291/002 FSN 20-Jan-09 Goodman Medical Supplies Ltd

ThermoFisher BO0351E, Tryptone soya broth, lot number 1045903 MHRA 2008/012/015/601/004 FSN 20-Jan-09 N.A.

Ortho Solutions FPS Locking Screws (14mm/18ms) MHRA 2008/010/017/401/001 FSN 20-Jan-09 N.A.

ThermoFisher TPHA Test Kit MHRA 2008/012/022/051/001 FSN 20-Jan-09 N.A.

BioMerieux Chocolate PolyViteX VCAT3 agar MHRA 2008/012/001/601/001 FSN 21-Jan-09 Biomerieux China Ltd. (HK office)

Diagnostica Stago STA - Cuvettes MHRA 2008/012/030/291/017 FSN 21-Jan-09 Healthpro Technology Co. Ltd

Abbott CELL-DYN Sapphire Haemoglobin Reagent Syringe 08H49-02 MHRA 2008/012/022/601/003 FSN 21-Jan-09 Abbott Laboratories LTD.

Smiths Medical BCI 9200 Advisor Vital Signs Monitor MHRA 2008/012/030/061/006 FSN 21-Jan-09 Goodman Medical Supplies Ltd

CMS Software 4.3.1 through 4.40.00 MHRA 2008/012/012/601/004 FSN 21-Jan-09 N.A.

Sorin Mini Bypass Bag MHRA 2008/012/031/061/002 FSN 21-Jan-09 N.A.

Days Healthcare Walking frame MHRA 2008/010/007/401/016 FSN 21-Jan-09 N.A.

Olympus PK7300 blood grouping system MHRA 2008/012/023/051/002 FSN 21-Jan-09 Olympus Hong Kong and China Limited

Siemens Sentinel Apolipoprotein B MHRA 2009/001/005/061/005 FSN 21-Jan-09 Siemens Healthcare Diagnostic Limited

Otto Bock Blizzard Active Wheelchair MHRA 2008/012/029/301/002 FSN 21-Jan-09 N.A.

Bausch & Lomb Akreos Advanced Optics Aspheric Lens MHRA 2008/012/019/291/002 FSN 21-Jan-09 Bausch & Lomb (Hong Kong ) Ltd

Maquet SERVO 300A Automode MHRA 2008/012/016/061/001 FSN 21-Jan-09 Maquet Hong Kong LTD.

Philips Pulmonary Toolkit MHRA 2008/012/029/291/001 FSN 22-Jan-09 Philips Health Care (Great China)

Medtronic MicroTargetingTM Drive System and Accessories MHRA 2008/012/030/291/011 FSN 22-Jan-09 Medtronic International, Ltd.

Baxter System 1000 Series of Hemodialysis Instruments with 4.D.0.3 or 4.D.0.4

SoftwareMHRA 2009/001/013/291/003 FSN 22-Jan-09 Baxter Healthcare Ltd

Kivi Uniloc wheelchair docking system AKE 04 MHRA 2009/001/012/301/001 FSN 22-Jan-09 N.A.

Varian Medical Systems Eclipse 8.5 (build 8.2.2X) systems with distributed Calculation

Framework (DCF) 8.2.22 (Model no H48)FDA N.A. Class II 22-Jan-09 Varian Medical Systems Pacific Inc.

GE Centricity Enterprise Web 3.0 software FDA Z-0870-2009 Class II 22-Jan-09 GE Medical Systems Hong Kong Ltd.

Stryker Triathlon PKR Insert X3#1 LM/RL-8mm (Catalog no.: 5630-G-108) and

Triathlon PKR Insert X3#1 RM/LL -12mm (Catalog no: 5630-G-122)FDA Z-0869-2009 Class II 22-Jan-09 Stryker China Ltd

Siemens Ariste MV Digital Linear Accelerator FDA Z-0857-2009 Class II 22-Jan-09 Siemens Healthcare Diagnostic Limited

Dade Behring (a Siemens Company) Dimension EXL Clinical Chemistry System FDA Z-0581-2009 Class II 22-Jan-09 Siemens Healthcare Diagnostic Limited

Abbott Clinical Chemistry Bilirubin Calibrator FDA Z-0580-2009 Class II 22-Jan-09 Abbott Laboratories LTD.

Depuy (Johnson and Johnson) DELTA Xtend, Standard Humeral PE Cup FDA Z-0532-2009 to Z-0539-2009 Class II 22-Jan-09 Johnson & Johnson Medical (HK)

Beckman Coulter Cytomics FC 500 Flow Cytometry System with CXP Software

Version 2.2 (Part no 626553)FDA Z-0129-2009 Class II 22-Jan-09 Beckman Coulter Hong Kong Ltd

Biomet Microplasty Elite Instruments Vanguard Slidex Femoral Block FDA Z-0873-2009 to Z-0882-2009 Class II 22-Jan-09 N.A.

Accuray RoboCouch Patient Support System (Model No 025007) FDA Z-0856-2009 Class II 22-Jan-09 Accuray Asia Ltd

VIBE Quantum Pulse machine FDA Z-0582-2009 Class II 22-Jan-09 N.A.

Sterilmed various products FDA Z-0546-2009 to Z-0577-2009 Class II 22-Jan-09 N.A.

Nutricia Enteral feeding pump MHRA MDA/2009/004 MDA 23-Jan-09 N.A.

Schulke & Mayr Mikrozid sensitive wipes MHRA 2008/011/019/061/022 FSN 23-Jan-09 N.A.

Cardinal Health Alaris GP LVP (Model 80063UN01), Alaris GP Guardrails Volumetric

Pump (Model 80263UN01-G)MHRA 2009/001/005/061/007 FSN 23-Jan-09 N.A.

Proact Medical Green System Duo Laryngoscope Handle MHRA 2008/010/024/401/007 FSN 23-Jan-09 N.A.





































http://www.mhra.gov.uk/Publications/Safetywarnings/MedicalDeviceAlerts/CON036273




GE OEC 7600 and OEC 7700 MHRA 2009/001/009/061/002 FSN 29-Jan-09 GE Medical Systems Hong Kong Ltd.

Elekta Leksell GainmaPlan / Leksell SurgiPlan MHRA 2008/012/017/061/006 FSN 29-Jan-09 N.A.

Stryker HA Hip Stems: ABG II, Omnifit C-Taper, Accolade MHRA 2009/001/007/061/008 FSN 29-Jan-09 Stryker China Ltd

Roche Hitachi 917 Modular Analytics MHRA 2008/011/026/291/009 FSN 29-Jan-09 Roche Diagnostics (Hong Kong) Ltd

ThermoFisher Lactose peptone water with Durham's tube - BO0435B MHRA 2009/001/012/601/001 FSN 29-Jan-09 N.A.

Joint Replacement Instrumentation BiPolar Head MHRA 2009/001/008/061/005 FSN 29-Jan-09 N.A.

A2U Nano supportive seating system MHRA 2008/012/023/401/006 FSN 29-Jan-09 N.A.

Advanced Healthcare Technology Babypod II, Evo2 and Evo3 MHRA 2008/012/012/401/010 FSN 29-Jan-09 N.A.

Siemens Somatom Definition AS MHRA 2008/012/012/291/003 FSN 29-Jan-09 Siemens Healthcare Diagnostic Limited

Siemens syngo Workflow MLR MHRA 2008/012/022/051/003 FSN 29-Jan-09 Siemens Healthcare Diagnostic Limited

Stryker Pneumo Sure XL High Flow Insufflator MHRA 2009/001/016/291/004 FSN 29-Jan-09 Stryker China Ltd

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

Complex, ACCUPROBE M. avium ComplexMHRA 2009/001/014/601/004 FSN 29-Jan-09 N.A.

Croma-Pharma Quatrix Acrylic Intraocular lenses with a preloaded injector MHRA 2009/001/012/291/017 FSN 29-Jan-09 N.A.

ThermoFisher Oxoid Staphytect Plus Dry Spot Kit MHRA 2008/010/017/061/003 FSN 29-Jan-09 N.A.

Invacare Action® 2000 Manual Wheelchair MHRA 2008/010/020/401/012 FSN 29-Jan-09 N.A.

Philips PCR Eleva MHRA 2009/001/021/291/004 FSN 29-Jan-09 Philips Health Care (Great China)

Coloplast Philips Catheter, 1Eye, Female Metric Thread (Catalogue no. AG55)Coloplast

(HK) LtdN.A.

Firm Initiated

Field Action30-Jan-09 Coloplast (HK) LTD

Bausch & Lomb High Speed Vitrectomy cutter product (CX4804)Bausch &

LombN.A.

Firm Initiated

Field Action30-Jan-09 Bausch & Lomb (Hong Kong ) Ltd

Stryker Endoscopy FloControl Arthroscopy Pump Integrated Tubing (Model no

0350600006)FDA Z-0652-2009 Class II 30-Jan-09 Stryker China Ltd

Stryker Vision 3 Flat Panel Shroud (Part#0682-000-414, 0682-000-415 and 0682-000-

416)FDA Z-0625-2009 Class II 30-Jan-09 Stryker China Ltd

Stryker Dri-Lok Disposable Cannula FDA Z-0868-2009 Class II 30-Jan-09 Stryker China Ltd

Philips Vertical drive brake on patient supports FDA Z-0597-2009 Class II 30-Jan-09 Philips Health Care (Great China)

Philips NeuViz Dual Multi-Slice Computed Tomography (CT) Scanner System

(software)FDA Z-0001-2009 Class II 30-Jan-09 Philips Health Care (Great China)

Accuray CyberKnife Robotic Radiosurgery System FDA Z-0629-2009 Class II 30-Jan-09 Accuray Asia Ltd

GE Innova 2100IQ, 3100/3100IQ, 4100/4100IQ FDA Z-0473-2009 to Z-0475-2009 Class II 30-Jan-09 GE Medical Systems Hong Kong Ltd.

Cardinal Health Esmark Elastic Bandage FDA Z-0615-2009 to Z-0616-2009 Class II 30-Jan-09 N.A.

INGfertility Pre Isotonic Personal Lubricant labeled PRE' Patient Lubricant FDA Z-0626-2009 Class II 30-Jan-09 N.A.

Alimed Gait Belt (Transfer Aid) (Model 72108, 72109) FDA Z-0598-2009 Class II 30-Jan-09 N.A.

Quantimetrix QuanTscopics Urine Microscopics Contro FDA Z-0513-2009 to Z-0516-2009 Class II 30-Jan-09 N.A.

Hill- Rom 70 Semi-Electric Bed (Model HS-968) FDA Z-0506-2009 Class II 30-Jan-09 N.A.

Ansell Healthcare Products Conform XT - Gloves (Model: 69318) Health Canada 45563 Type II 30-Jan-09 N.A.

Ossur HF ReSolve Open Back Halo Ring Health Canada 45100 Type II 30-Jan-09 N.A.

Maquet Reservoirs (BEQ-VHK 2001) Health Canada 45565 Type II 30-Jan-09 Maquet Hong Kong LTD.

Styker Dri-Lok Disposable Cannulas Health Canada 45616 Type II 30-Jan-09 Stryker China Ltd

BHM Medical Ergolift, Ergolift-2 Health Canada 45626 Type I 30-Jan-09 Arjo Huntleigh (Hong Kong) Ltd.

Roche Diagnostics Process System Manager (Model: 3009696001) Health Canada 45358 Type I 30-Jan-09 Roche Diagnostics (Hong Kong) Ltd
































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






Baxter Colleague Volumetric Infusion Pump (Model: 2M8151K) Health Canada 41402 Type II 30-Jan-09 Baxter Healthcare Ltd

Harvest Technologies Autologous Platelet Concentrate System (Model: APC-201) Health Canada 45706 Type II 30-Jan-09 N.A.

Philips A) Multidiagnost Eleva - Image Intensifier (70832), B) Multidiagnost Eleva - Flat

Detector (70834), C) Omnidiagnost Eleva (Model: 708027)Health Canada 45311 Type II 30-Jan-09 Philips Health Care (Great China)

White Peaks Dental Systems Origin YZ Zirconia Blocks, Origin YZ Zirconia Disc Health Canada 44705 Type II 30-Jan-09 N.A.

MC Healthcare Products QP2508 Hand Pendant (Model: HB43-U010-00/01 Health Canada 45786 Type II 30-Jan-09 N.A.

Smiths Medical Medfusion Syringe Pump (Model: 3500-306, 3500-415) Health Canada 45802 Type II 30-Jan-09 N.A.










Documents

Monthly Summary of Medical Device Safety Alerts - January 2009