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Field Safety Notification for Reamer / Irrigator / Aspirator-System (RIA), DePuy Synthes PDF, 355KB, File does not meet accessibility standards Date: 18. February 2016 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - bone surgery
Reference 04233/15

Recall of PO830SU / PO831SU / PO833SU, Aesculap AG PDF, 373KB, File does not meet accessibility standards Date: 18. February 2016 Topics: Medical devices Type: Customer information

Product group Optics / Precision engineering - endoscopes
Reference 01308/16

Urgent field safety notice for deltastream MDC, i-cor and iLA activve consoles, Medos Medizintechnik AG PDF, 271KB, File does not meet accessibility standards Date: 18. February 2016 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 01305/16

Field Safety Corrective Action for PROTIME lnRhythm System / PT Test Cuvettes, Accriva Diagnostic PDF, 291KB, File does not meet accessibility standards Date: 18. February 2016 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - haematological, histological and cytological products
Reference 00893/16

Lot recall for Silverline Lumbar Drainage Catheter, Spiegelberg GmbH & Co. KG PDF, 167KB, File does not meet accessibility standards Date: 18. February 2016 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - injection kits
Reference 01333/16

Urgent field safety notice for Pima Analyser, Alere Technologies GmbH PDF, 48KB, File does not meet accessibility standards Date: 18. February 2016 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - haematological, histological and cytological products
Reference 08851/15

Urgent field safety notice for Drive Gas Check Valve on certain Anesthesia products, GE Healthcare PDF, 110KB, File does not meet accessibility standards Date: 18. February 2016 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply
Reference 01013/16

Batch recall for ENT single-use suction tubes, Spiggle & Theis Medizintechnik GmbH PDF, 295KB, File does not meet accessibility standards Date: 18. February 2016 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 01239/16

Urgent field safety notice for HemosIL Plasminogen, Instrumentation Laboratory / Werfen PDF, 129KB, File does not meet accessibility standards Date: 18. February 2016 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - haematological, histological and cytological products
Reference 01189/16

Urgent Field Safety Notice for cobas p 512 pre-analytical system, Roche PDF, 77KB, File does not meet accessibility standards Date: 18. February 2016 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 01081/16

Recall of DVR ePAKs, Zimmer Biomet PDF, 197KB, File does not meet accessibility standards Date: 18. February 2016 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 01176/16

Urgent field safety notice for care beds VSA 644 and VS stand-up accessory, Mauser Einrichtungssysteme GmbH & Co. KG PDF, 149KB, File does not meet accessibility standards Date: 18. February 2016 Topics: Medical devices Type: Customer information

Product group General equipment for medical treatment - furnishings
Reference 01209/16

Recall of IBS II spreaders PT 6 mm / 8 mm / 10 mm and IBS II spreaders O 6 mm / 8 mm, Peter Brehm GmbH PDF, 176KB, File does not meet accessibility standards Date: 18. February 2016 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - general instruments
Reference 00844/16

Urgent field safety notice for BTV (Bag to Ventilation) Switch Issue on Carestation 600 Series Anesthesia Systems, GE Healthcare PDF, 116KB, File does not meet accessibility standards Date: 18. February 2016 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply
Reference 01114/16

Field Safety Corrective Action for Coban 2 and Coban 2 Lite (compression layers only), 3M Deutschland GmbH PDF, 144KB, File does not meet accessibility standards Date: 18. February 2016 Topics: Medical devices Type: Customer information

Product group Orthopaedic / Rehabilitation technology - orthoses
Reference 01347/16

Urgent field safety notice for Acetaminophen L3K Assay, Sekisui Diagnostics PDF, 238KB, File does not meet accessibility standards Date: 17. February 2016 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 00585/16

Urgent field safety notice for Cholinesterase 981370, Thermo Fisher Scientific Oy PDF, 239KB, File does not meet accessibility standards Date: 17. February 2016 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 00842/16

Urgent field safety notice for Flexion Port 300 / 350 / 400, Richard Wolf GmbH PDF, 942KB, File does not meet accessibility standards Date: 17. February 2016 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 00976/16

Batch recall for enteral syringe Freka Connect ENLock 5 ml, Fresenius Kabi Deutschland GmbH PDF, 27KB, File does not meet accessibility standards Date: 17. February 2016 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - probes
Reference 00055/16

Field Safety Corrective Action for HU35 / HCU20 / HCU30 / HCU40 systems, Maquet Cardiopulmonary GmbH PDF, 239KB, File does not meet accessibility standards Date: 17. February 2016 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 09555/15

Urgent Field Safety Notice for Accu-Chek Inform II Base Units (BU) and Handheld Base Units (HBU) used for CoaguChek Professional meters and cobas h232 meters, Roche PDF, 225KB, File does not meet accessibility standards Date: 17. February 2016 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 00797/16

Urgent Field Safety Notice for ADVIA Centaur / Centaur XP / Centaur XPT / Centaur Systems Calibrator E Lot to Lot Bias with Testosterone Assay, Siemens Healthcare Diagnostics Inc. PDF, 60KB, File does not meet accessibility standards Date: 17. February 2016 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 01120/16

Lot recall for CA500 Epix Universal Clip Applier, Applied Medical Europe BV PDF, 318KB, File does not meet accessibility standards Date: 17. February 2016 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - general instruments
Reference 01036/16

Lot recall for defibrillation electrode, Leonhard Lang GmbH PDF, 159KB, File does not meet accessibility standards Date: 17. February 2016 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrotherapy
Reference 01049/16

Urgent field safety notice for monitor mounts and support arms with rotatable 75 / 100 adaptation, Gimmi GmbH PDF, 250KB, File does not meet accessibility standards Date: 17. February 2016 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 00890/16

Urgent Field Safety Notice for syngo RT Therapist 4.3.1_MR2 with Digital Linear Accelerator of type ONCOR or ARTISTE, Siemens Healthcare GmbH PDF, 25KB, File does not meet accessibility standards Date: 17. February 2016 Topics: Medical devices Type: Customer information

Product group Radiotherapy / Radiation protection - radiotherapy treatment planning systems
Reference 00957/16

Lot recall for PVC Trocar catheter CH 24, Redax SpA PDF, 46KB, File does not meet accessibility standards Date: 17. February 2016 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - catheters
Reference 00956/16

Lot recall for Trinity Acetabular Shell, Corin Limited PDF, 352KB, File does not meet accessibility standards Date: 17. February 2016 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 00954/16