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Urgent field safety notice for Ellipse Nordlys / Sirius, Ellipse A/S PDF, 26KB, File does not meet accessibility standards Date: 04. February 2016 Topics: Medical devices Type: Customer information

Product group Optics / Precision engineering - laser technology
Reference 08926/15

Recall of guiding wires item no. 1311130, ANGIOKARD Medizintechnik GmbH PDF, 467KB, File does not meet accessibility standards Date: 04. February 2016 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - catheters
Reference 00034/16

Urgent field safety notice for Brain Metastases version 1.0.0 and Adaptive Hybrid Surgery Analysis version (AHSA) 1.0.0, Brainlag AG PDF, 190KB, File does not meet accessibility standards Date: 04. February 2016 Topics: Medical devices Type: Customer information

Product group Radiotherapy / Radiation protection - radiotherapy treatment planning systems
Reference 00028/15

Batch recall for BacT/ALERT Culture bottles, bioMérieux Inc. PDF, 260KB, File does not meet accessibility standards Date: 04. February 2016 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - microbiological products
Reference 00031/16

Urgent field safety notice for Endo GIA Ultra Universal Stapler Handles, Medtronic PDF, 173KB, File does not meet accessibility standards Date: 04. February 2016 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - general instruments
Reference 09169/15

Urgent field safety notice for Model 106 AspireSR VNS Therapy generator, Cyberonics PDF, 100KB, File does not meet accessibility standards Date: 04. February 2016 Topics: Medical devices Type: Customer information

Product group Active implantable medical devices - biostimulators
Reference 09718/15

Urgent Field Safety Notice for all VITRO systems, Ortho Clinical Diagnostics Inc. (Ortho) PDF, 869KB, File does not meet accessibility standards Date: 04. February 2016 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 09766/15

Corrective action for the Reflotron Uric Acid test, Roche Diagnostics GmbH PDF, 78KB, File does not meet accessibility standards Date: 04. February 2016 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 04200/15

Urgent field safety notice for Concerto & Basic Shower Trolleys, ArjoHuntleigh PDF, 172KB, File does not meet accessibility standards Date: 03. February 2016 Topics: Medical devices Type: Customer information

Product group Orthopaedic / Rehabilitation technology - daily living aids
Reference 09431/15

Field Safety Corrective Action for EdgeLab versions 6.4.0.x, 6.4.1.x, 6.5.0.x (previously called LABO server), Inlog S.A.S. PDF, 59KB, 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 09797/15

Urgent Field Safety Notice for FLOW-i C20, C30 and C40, Maquet Critical Care AB PDF, 82KB, 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 09465/15

Component replacement for monitor mounts and support arms with rotatable VESA 75 / 100 adaptation, ITD GmbH PDF, 187KB, File does not meet accessibility standards Date: 03. February 2016 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 09710/15

Recall of various RF Syringe Strips, Baxter International Inc. PDF, 62KB, File does not meet accessibility standards Date: 03. February 2016 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - syringes and cannulas
Reference 09759/15

Modification and replacement of instruction for use of Vortek Single loop Ureteral Stents, Coloplast A/S PDF, 298KB, File does not meet accessibility standards Date: 03. February 2016 Topics: Medical devices Type: Customer information

Product group Non-active implants - special implants
Reference 02951/15

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