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14,972 results

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Batch recall for FMC7 FITC (CE-IVD), Becton Dickinson France S.A.S. Belgian Branch PDF, 95KB, File does not meet accessibility standards Date: 03. February 2016 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - haematological, histological and cytological products
Reference 09713/15

Urgent corrective action for Dimension Integrated Chemistry Systems, Siemens Healthcare Diagnostics Inc. PDF, 112KB, File does not meet accessibility standards Date: 03. February 2016 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 09269/15

Corrective action for Schaftansatz, rund, Hartschaum 125 kg, medi GmbH & Co. KG PDF, 476KB, File does not meet accessibility standards Date: 03. February 2016 Topics: Medical devices Type: Customer information

Product group Orthopaedic / Rehabilitation technology - prostheses (exoprostheses)
Reference 07710/15

Urgent field safety notice for API ZYM Bx2 (Ref. 70493), bioMérieux SA PDF, 346KB, File does not meet accessibility standards Date: 03. February 2016 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - microbiological products
Reference 09757/15

Urgent corrective action for Source Administration Sets (SAS) used with Medrad Intego PET Infusion System, Bayer Medical Care / Bayer HealthCare PDF, 581KB, File does not meet accessibility standards Date: 03. February 2016 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - infusion technology
Reference 09477/15

Urgent Field Safety Notice for Zilver 518RX Vascular Stent, Cook Ireland Ltd. / Cook Medical Europe / Cook Medical EUDC PDF, 45KB, File does not meet accessibility standards Date: 03. February 2016 Topics: Medical devices Type: Customer information

Product group Non-active implants - special implants
Reference 09724/15

Field Safety Notice for Astral 100 and Astral 150 as well as Astral 100 and Astral 150 devices with SR1.1 software (SX544-0301), ResMed Ltd. / ResMed Paris PDF, 308KB, File does not meet accessibility standards Date: 03. February 2016 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply
Reference 09785/15

Urgent Field Safety Notice for IntelliVue Info Center iX A.0, PIIC Classic Upgrade and IntelliVue Info Center iX B.0, Philips Healthcare PDF, 263KB, File does not meet accessibility standards Date: 03. February 2016 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrodiagnostics
Reference 09769/15

Corrective action for Unicel DxH 800 Coulter Cellular Analysis System, Unicel DxH SMS Coulter Cellular Analysis System and Unicel DxH 600 Coulter Cellular Analysis System, Beckman Coulter PDF, 146KB, File does not meet accessibility standards Date: 03. February 2016 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - haematological, histological and cytological products
Reference 09613/15

Recall of Guiding Rod 60900-66-2, Peter Brehm GmbH PDF, 100KB, File does not meet accessibility standards Date: 03. February 2016 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - bone surgery
Reference 09790/15

Urgent Field Safety Notice for 3.0T 6 Channel Flex Coil in 3T MR750W Surgical Suite Scanners, GE Healthcare PDF, 189KB, File does not meet accessibility standards Date: 03. February 2016 Topics: Medical devices Type: Customer information

Product group Electromedical fields - equipment for MR tomography
Reference 09754/15

Batch recall of PFNA, PFNA-II, DFN & PFN Nails, PFNA & PFNA-II Blades and
PFNA & PFNA-II End Cap Extensions, DePuy Synthes / Synthes GmbH
PDF, 472KB, File does not meet accessibility standards
Date: 02. February 2016 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 09730/15

Corrective action für CVC sets SAFE, Vygon GmbH & Co. KG PDF, 209KB, File does not meet accessibility standards Date: 02. February 2016 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - catheters
Reference 09728/15

Field safety notice for VERO / MHI-TM2000 Linear Accelerator System, Mitsubishi Heavy Industries, Ltd. (MHI) / Brainlab AG PDF, 165KB, File does not meet accessibility standards Date: 02. February 2016 Topics: Medical devices Type: Customer information

Product group Radiotherapy / Radiation protection - radiation facilites with accelerators for teletherapy
Reference 09597/15

Field safety notice for SMR Glenosphere Impactor / Extractor, Limacorporate S.p.A. PDF, 173KB, File does not meet accessibility standards Date: 02. February 2016 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - bone surgery
Reference 09526/15

Batch recall of neXtra Cutter Shaver Blades (3.5 mm Aggressive Blade and 3.5 mm Ultra-Aggressive Blade), DePuy Mitek, Inc. / Mitek Sports Medicine PDF, 56KB, File does not meet accessibility standards Date: 02. February 2016 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 09142/15

Batch recall of Sterimax Wipes, Aseptix Professional Products BV PDF, 113KB, File does not meet accessibility standards Date: 02. February 2016 Topics: Medical devices Type: Customer information

Product group General equipment for medical treatment - cleaning / disinfection / sterilisation
Reference 09683/15

Recall of Reach System Handle Instrument, DePuy Synthes PDF, 164KB, File does not meet accessibility standards Date: 02. February 2016 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - bone surgery
Reference 08510/15

Corrective action for Extension Device 1180.19X0, MAQUET GmbH PDF, 563KB, File does not meet accessibility standards Date: 02. February 2016 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 09639/15

Urgent Field Safety Notice for Single Use Laryngeal Mask Sterile, Ambu PDF, 183KB, File does not meet accessibility standards Date: 02. February 2016 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply
Reference 09413/15

Urgent Field Safety Notice for NidOil, NidaCon International AB PDF, 123KB, File does not meet accessibility standards Date: 02. February 2016 Topics: Medical devices Type: Customer information

Product group Physical therapy - others
Reference 09685/15

Important safety information for Oxylog 3000, Oxylog 3000 plus and Oxylog 2000 plus, Drägerwerk AG & Co. KGaA PDF, 164KB, File does not meet accessibility standards Date: 02. February 2016 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply
Reference 09680/15

Urgent field safety notice for Oncentra External Beam, Nucletron B. V., subsidiary of Elekta AB PDF, 144KB, File does not meet accessibility standards Date: 02. February 2016 Topics: Medical devices Type: Customer information

Product group Radiotherapy / Radiation protection - radiotherapy treatment planning systems
Reference 09671/15

Urgent field safety corrective action for Heater and Heater / Cooler Systems HU35, HCU20, HCU30 and HCU40, Maquet Cardiopulmonary AG PDF, 452KB, File does not meet accessibility standards Date: 02. February 2016 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 09132/15

Urgent field safety notice for Original M. E. Müller Low Profile cup, Zimmer GmbH PDF, 521KB, File does not meet accessibility standards Date: 02. February 2016 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 09678/15

Recall of Stent system sinus-Carotid-RX and sinus-Carotid-Conical-RX, optimed GmbH PDF, 183KB, File does not meet accessibility standards Date: 01. February 2016 Topics: Medical devices Type: Customer information

Product group Non-active implants - special implants
Reference 08385/15

Urgent field safety notice for EFK-Femur Right, OHST Medizintechnik AG PDF, 201KB, File does not meet accessibility standards Date: 01. February 2016 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 09339/15

Urgent field safety notice for MEDUMAT Standard² with CO2 module, WEINMANN Emergency Medical Technology GmbH + Co. KG PDF, 74KB, File does not meet accessibility standards Date: 01. February 2016 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply
Reference 09442/15

Urgent field safety notice for AK 200 S and AK 200 ULTRA S dialysis machines, Baxter / Gambro PDF, 73KB, File does not meet accessibility standards Date: 01. February 2016 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - dialysis technology
Reference 09621/15

Field Safety Notice for 02-090 Wundnahtstreifen, Wundmed GmbH & Co. KG PDF, 19KB, File does not meet accessibility standards Date: 01. February 2016 Topics: Medical devices Type: Customer information

Product group Dressings / Pads - dressings
Reference 09628/15