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Urgent field safety notice for TruLab controls and TruCal U calibrator, DiaSys Diagnostic Systems GmbH PDF, 127KB, File does not meet accessibility standards Date: 21. March 2016 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 01903/16

Urgent field safety notice for EB010 - Voyant 5mm Fusion / 37mm 6NE, Applied Medical PDF, 65KB, File does not meet accessibility standards Date: 21. March 2016 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrotherapy
Reference 02233/16

Lot recall for QuantiFERON-TB (QFT) Gold TB-Antigen blood collection tubes, QIAGEN GmbH PDF, 62KB, File does not meet accessibility standards Date: 21. March 2016 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - microbiological products
Reference 01503/16

Urgent field safety notice for Glucose 201 RT Microcuvettes, HemoCue AB PDF, 330KB, File does not meet accessibility standards Date: 21. March 2016 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 01620/16

Urgent field safety notice for Elecsys Estradiol II, Roche Diagnostics PDF, 119KB, File does not meet accessibility standards Date: 21. March 2016 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - immunological products
Reference 01835/16

Lot recall for RESTORIS MCK Baseplate, Stryker Orthopaedics PDF, 128KB, File does not meet accessibility standards Date: 21. March 2016 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 01567/16

Batch recall for BIOLOX DELTA REVISION HEAD 12/14 32MM S, Aesculap AG PDF, 213KB, File does not meet accessibility standards Date: 21. March 2016 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 01927/16

Urgent field safety notice for Symbia E and e.cam, Siemens Medical Solutions USA Inc. PDF, 173KB, File does not meet accessibility standards Date: 21. March 2016 Topics: Medical devices Type: Customer information

Product group Radiological technology - equipment for nuclear medical functional and localisation diagnostics
Reference 01914/16

Lot recall of ADVIA Chemie Triglyceride-Reagent (TRIG_c), Siemens Healthcare Diagnostics GmbH PDF, 22KB, File does not meet accessibility standards Date: 21. March 2016 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 02099/16

Urgent Field Safety Notice for ZX1 / ZX3 Wheelchairs, MEYRA GmbH PDF, 89KB, File does not meet accessibility standards Date: 21. March 2016 Topics: Medical devices Type: Customer information

Product group Orthopaedic / Rehabilitation technology - mobility aids
Reference 09617/15

Urgent field safety notice for VERO / MHI-TM2000 Linear Accelerator System with software version 3.5.8, 3.5.2 and lower, MITSUBISHI HEAVY INDUSTRIES LTD. PDF, 155KB, File does not meet accessibility standards Date: 21. March 2016 Topics: Medical devices Type: Customer information

Product group Radiotherapy / Radiation protection - radiation facilites with accelerators for teletherapy
Reference 01893/16

Urgent Field Safety Notice for NeoCoi1 3.0T GEMflex Coil with GE Healthcare 3.0T Scanners / GE Healtcare PDF, 522KB, File does not meet accessibility standards Date: 21. March 2016 Topics: Medical devices Type: Customer information

Product group Active implantable medical devices - cardiac pacemakers
Reference 01182/16

Urgent field safety notice for Universal SlingBar 350 / 450 / 600 (may be bundled with Golvo, Uno, LikoLight, Likorall, Multirall and Viking XS/S/M/L mobile patient lifts, Hill-Rom PDF, 488KB, File does not meet accessibility standards Date: 17. March 2016 Topics: Medical devices Type: Customer information

Product group General equipment for medical treatment - ward equipment and equipment for emergency medical services
Reference 01277/16

Urgent field safety notice for QUIK-COMBO pacing / defibrillation / ECG electrodes with EDGE System technology and REDI-PAK preconnect system, Physio-Control Inc. PDF, 148KB, File does not meet accessibility standards Date: 17. March 2016 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrotherapy
Reference 01092/16

Urgent Field Safety Notice for Splash Pool Lift, S. R. Smith PDF, 254KB, File does not meet accessibility standards Date: 17. March 2016 Topics: Medical devices Type: Customer information

Product group General equipment for medical treatment - ward equipment and equipment for emergency medical services
Reference 01461/16

Lot recall of Guardian II Hemostasis Valve, model numbers FH101, FH101-T, FH101-25 und FH101-50, Vascular Solutions Inc. PDF, 188KB, File does not meet accessibility standards Date: 16. March 2016 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - catheters
Reference 02212/16

Batch recall of TC-PLUS Primary Fixed Tibial Components VKS (cemented and non-cemented), Smith & Nephew Orthopaedics AG PDF, 86KB, File does not meet accessibility standards Date: 16. March 2016 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 02220/16

Urgent field safety notice for RHK Knee 16 mm Bearing for 71 mm, 75 mm & 79 mm RHK Tibial Tray, Biomet UK Ltd. / Zimmer Biomet PDF, 303KB, File does not meet accessibility standards Date: 16. March 2016 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 02040/16

Lot recall of Medivance ARCTICGEL Pads, Bard Limited PDF, 60KB, File does not meet accessibility standards Date: 16. March 2016 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 02201/16

Batch recall for BDyn implants, BIOSPINE Implants / S14 Implants PDF, 42KB, File does not meet accessibility standards Date: 16. March 2016 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 01989/16

Urgent field safety notice for POLYMAILLE EXTRA THIN vascular prostheses, PEROUSE MEDICAL PDF, 358KB, File does not meet accessibility standards Date: 16. March 2016 Topics: Medical devices Type: Customer information

Product group Non-active implants - special implants
Reference 03559/15

Urgent field safety notice for Aisys CS2 and upgraded Aisys devices, GE Healthcare PDF, 112KB, File does not meet accessibility standards Date: 16. March 2016 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply
Reference 02166/16

Batch recall of Revitan proximal spout stems (Size 55-105) and Revitan
proximal cylindrical stems (Size 55-105), Zimmer GmbH
PDF, 499KB, File does not meet accessibility standards
Date: 16. March 2016 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 02195/16

Urgent field safety notice for Lightspeed CT, Discovery ST PET CT and Discovery LS PET CT scanner, GE Healthcare PDF, 245KB, File does not meet accessibility standards Date: 16. March 2016 Topics: Medical devices Type: Customer information

Product group Radiological technology - CT scanners
Reference 01995/16

Urgent field safety notice for iChemVELOCITY automated urine chemistry system using iChemVELOCITY urine chemistry strips, IRIS International Inc. / Beckman Coulter PDF, 109KB, File does not meet accessibility standards Date: 16. March 2016 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 01974/16

Urgent Field Safety Notice for Free ßhCG KRYPTOR, B-R-A-H-M-S GmbH / ThermoFisher Scientific PDF, 242KB, File does not meet accessibility standards Date: 16. March 2016 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - immunological products
Reference 01742/16

Corrective action for the MicroScan LabPro Information Manager System, Beckman Coulter PDF, 306KB, File does not meet accessibility standards Date: 15. March 2016 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - microbiological products
Reference 05029/15

Lot recall of HbA1c 501 Test Cartridges, HemoCue AB / Infopia Co. Ltd. PDF, 138KB, File does not meet accessibility standards Date: 15. March 2016 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 08718/15