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Urgent field safety notice for ALT OSR6X07 / Glucose-Stat OSR6X40, Beckman Coulter PDF, 256KB, File does not meet accessibility standards Date: 03. June 2016 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - immunological products
Reference 04663/16

Urgent field safety notice for StreamLAB Automation Solutions / Aptio Automation/ FlexLab / Hettich Centrifuge Bucket Model 4464-R, Siemens Healthcare Diagnostics Inc. PDF, 25KB, File does not meet accessibility standards Date: 03. June 2016 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 04614/16

Urgent field safety notice for Quo-Test HbA1c Analyser, EKF diagnostic GmbH PDF, 336KB, File does not meet accessibility standards Date: 03. June 2016 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 04639/16

Urgent field safety notice for RayStation 5, RaySearch Laboratories AB PDF, 482KB, File does not meet accessibility standards Date: 03. June 2016 Topics: Medical devices Type: Customer information

Product group Radiotherapy / Radiation protection - radiotherapy treatment planning systems
Reference 04622/16

Batch recall of Affinis Fracture, Inverse, and Short implants with Ti/CaP coating, Mathys Ltd. Bettlach PDF, 53KB, File does not meet accessibility standards Date: 02. June 2016 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 04619/16

Urgent field safety notice for CENTURION FMS (Fluidics Management System) Pack for CENTURION Vision System, Alcon Pharma GmbH PDF, 425KB, File does not meet accessibility standards Date: 02. June 2016 Topics: Medical devices Type: Customer information

Product group ophthalmological technology - equipment for ophthalmological therapeutics
Reference 03829/16

Urgent field safety notice for Brio rechargeable IPG (Code 65-6788), St. Jude Medical PDF, 118KB, File does not meet accessibility standards Date: 02. June 2016 Topics: Medical devices Type: Customer information

Product group Active implantable medical devices - biostimulators
Reference 00523/16

Recall of PSS Midas Rex Sagittal Saws Models ES300 / ES300-R / ES310 / ES310-R, Medtronic PDF, 248KB, File does not meet accessibility standards Date: 02. June 2016 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 04553/16

Urgent Field Safety Notice for 2m Disposable Patient Hose Systems for MEDUMAT Transport / Standard², WEINMANN Emergency Medical Technology GmbH + Co. KG PDF, 215KB, File does not meet accessibility standards Date: 31. May 2016 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply
Reference 03985/16

Urgent field safety notice for da Vinci Xi 5-8 mm Universal Seal (PN 470361) and da Vinci Xi 12 mm & Stapler Universal Seal (PN 470380), Intuitive Surgical Inc. PDF, 87KB, File does not meet accessibility standards Date: 31. May 2016 Topics: Medical devices Type: Customer information

Product group Optics / Precision engineering - endoscopes
Reference 03970/16

Urgent field safety notice for Dimension Vista Flex Homocysteine (HCYS) reagent cartridge, Siemens Healthcare Products GmbH PDF, 27KB, File does not meet accessibility standards Date: 30. May 2016 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 04194/16

Lot recall of CinchLock SS Knotless Anchor with Inserter and CinchLock Flex Anchor with Inserter, Stryker PDF, 344KB, File does not meet accessibility standards Date: 30. May 2016 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 04432/16

Urgent field safety notice for disposable paediatric ventilation circuit VentStar Oxylog3000F (P) 190 for Oxylog 3000 and Oxylog 3000 plus, Drägerwerk AG & Co. KGaA PDF, 200KB, File does not meet accessibility standards Date: 30. May 2016 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply
Reference 04430/16

Lot recall of Ammonia reagent, Randox Laboratories Ltd. PDF, 102KB, File does not meet accessibility standards Date: 30. May 2016 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - immunological products
Reference 03957/16

Urgent field safety notice for Vancomycin (ONLINE TDM Vancomycin / HITACHI VANCOMYCIN), Roche PDF, 108KB, File does not meet accessibility standards Date: 30. May 2016 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 04342/16

Urgent field safety notice for Statlock IAB Stabilization Device (Mega / Sensation Plus catheter), Maquet / Getinge Group PDF, 104KB, File does not meet accessibility standards Date: 30. May 2016 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - catheters
Reference 04136/16

Lot recall of PRECISE PRO RX Nitinol Stent System, Cordis PDF, 259KB, File does not meet accessibility standards Date: 30. May 2016 Topics: Medical devices Type: Customer information

Product group Non-active implants - special implants
Reference 03895/16

Urgent field safety notice for Lifepak 15, Physio-Control Inc. PDF, 248KB, File does not meet accessibility standards Date: 27. May 2016 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrotherapy
Reference 04398/16

Urgent Field Corrective Action for N Latex HCY / N Latex HCY (BCS XP) reagent, Siemens Healthcare Diagnostics Products GmbH PDF, 28KB, File does not meet accessibility standards Date: 27. May 2016 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 04203/16

Urgent Field Safety Notice for deep brain stimulation devices Activa PC, Activa SC and Activa RC Devices, Medtronic PDF, 50KB, File does not meet accessibility standards Date: 25. May 2016 Topics: Medical devices Type: Customer information

Product group Active implantable medical devices - biostimulators
Reference 04162/16

Lot recall of Resolute Integrity Zotarolimus-Eluting Coronary Stent System, Medtronic PDF, 49KB, File does not meet accessibility standards Date: 25. May 2016 Topics: Medical devices Type: Customer information

Product group Non-active implants - special implants
Reference 04390/16

Urgent Field Safety Notice for Stratus CS 200 Acute Care Diagnostics System, Siemens Healthcare Diagnostics Inc. PDF, 27KB, File does not meet accessibility standards Date: 25. May 2016 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 04392/16

Urgent field safety notice for DX-D600, Agfa HealthCare NV PDF, 156KB, File does not meet accessibility standards Date: 25. May 2016 Topics: Medical devices Type: Customer information

Product group Radiological technology - stationary radiological equipment
Reference 03682/16

Lot recall of Fetal Scalp Blood Sampler, LiNA Medical ApS PDF, 197KB, File does not meet accessibility standards Date: 25. May 2016 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - syringes and cannulas
Reference 02269/16

Urgent field safety notice for MSK 1.5T Extreme and Optima MR430s Cryogen Vent, GE Healthcare PDF, 101KB, File does not meet accessibility standards Date: 25. May 2016 Topics: Medical devices Type: Customer information

Product group Electromedical fields - equipment for MR tomography
Reference 04339/16

Urgent field safety notice for Columbia CNA Aesculin Selective Agar /
McConkey Agar No. 3 (Mod), Oxoid Deutschland GmbH / Thermo Fisher Scientific
PDF, 122KB, File does not meet accessibility standards
Date: 25. May 2016 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - microbiological products
Reference 04140/16

Urgent field safety notice for various IVD, Erba Lachema s.r.o. PDF, 271KB, File does not meet accessibility standards Date: 25. May 2016 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 04202/16

Lot recall of SpeediCath ® Compact Eve CH 12, Coloplast A/S PDF, 299KB, File does not meet accessibility standards Date: 24. May 2016 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - catheters
Reference 03821/16

Lot recall of various sterile-packaged hip and trauma implant screws, Zimmer Biomet PDF, 309KB, File does not meet accessibility standards Date: 24. May 2016 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 04312/16

Urgent Field Safety Notice for Algovita Spinal Cord Stimulation System / Clinician Programmer (CP), NUVECTRA PDF, 129KB, File does not meet accessibility standards Date: 24. May 2016 Topics: Medical devices Type: Customer information

Product group Active implantable medical devices - biostimulators
Reference 03593/16