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Corrective action for Lynoamp® BC, Lynoamp® BC HTS and Lynoamp® CC, Sysmex PDF, 465KB, File does not meet accessibility standards Date: 23. January 2014 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - haematological, histological and cytological products
Reference 00036/14

Safety Notice for the product Desktop Pro™, Elekta PDF, 300KB, File does not meet accessibility standards Date: 23. January 2014 Topics: Medical devices Type: Customer information

Product group Radiotherapy / Radiation protection - radiation facilites with accelerators for teletherapy
Reference 07710/13

Safety Notice for the product Integrity™, Elekta PDF, 452KB, File does not meet accessibility standards Date: 23. January 2014 Topics: Medical devices Type: Customer information

Product group Radiotherapy / Radiation protection - radiation facilites with accelerators for teletherapy
Reference 07712/13

Corrective action for Vitek MS, bioMérieux PDF, 80KB, File does not meet accessibility standards Date: 22. January 2014 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - microbiological products
Reference 06358/13

Corrective action for Thermo Scientific Indiko and Indiko Plus analyzers, Thermo Fisher PDF, 131KB, File does not meet accessibility standards Date: 22. January 2014 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 07925/13

Corrective action for Citrate Activated Partial Thromboplastin Time (APTT) Cuvettes, ITC PDF, 35KB, File does not meet accessibility standards Date: 22. January 2014 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - haematological, histological and cytological products
Reference 07905/13

Safety Notice for the cardiovascular X-ray imaging systems Innova, GE Healthcare PDF, 126KB, File does not meet accessibility standards Date: 22. January 2014 Topics: Medical devices Type: Customer information

Product group Radiological technology - radiological equipment for vascular diagnostics
Reference 00115/14

Safety Notice for GE Anesthesia Devices, GE Healthcare PDF, 88KB, File does not meet accessibility standards Date: 22. January 2014 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply
Reference 02058/13

Lot Recall of the device PROPHYflex, KAVO DENTAL PDF, 54KB, File does not meet accessibility standards Date: 21. January 2014 Topics: Medical devices Type: Customer information

Product group Dental products - instruments
Reference 00058/14

Urgent Safety Notice for the Kodak 2100 and Kodak 2200 Intraoral X-Ray Systems, Carestream Health PDF, 177KB, File does not meet accessibility standards Date: 21. January 2014 Topics: Medical devices Type: Customer information

Product group Radiological technology - radiological equipment for stomatological diagnostics
Reference 00048/14

Stryker Neurovascular: Recall for Excelsior Microcatheters, GDC Coils, Neuroform EZ Stents and Transform Balloons PDF, 88KB, File does not meet accessibility standards Date: 21. January 2014 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - catheters
Reference 07196/13

Corrective action for Piccolo® Lipid Panel Plus, Abaxis PDF, 247KB, File does not meet accessibility standards Date: 20. January 2014 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 07672/13

Corrective action for Dimension® Clinical Chemistry Systems Dimension TACR Flex reagent cartridge, Siemens PDF, 34KB, File does not meet accessibility standards Date: 20. January 2014 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 02252/13

Corrective action for Liaison® Control Biotrin Parvovirus B19 IgM, Diasorin PDF, 109KB, File does not meet accessibility standards Date: 20. January 2014 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - microbiological products
Reference 07115/13

Corrective action for Campylobacter CCDA selective medium, Thermo Fisher PDF, 108KB, File does not meet accessibility standards Date: 20. January 2014 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - microbiological products
Reference 07469/13

Corrective action for RAPIDLyte Arterial Blood Sampling 3 ml Line Draw Syringes, Siemens PDF, 27KB, File does not meet accessibility standards Date: 20. January 2014 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - microbiological products
Reference 00020/14

Urgent Safety Notice for the Duowire™ guidewire, Coloplast PDF, 87KB, File does not meet accessibility standards Date: 20. January 2014 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - catheters
Reference 00006/14

Recall of one lot of the surgical suture MONOPLUS VIOLET o (3.5) 90 cm, B. Braun Surgical PDF, 3MB, File does not meet accessibility standards Date: 20. January 2014 Topics: Medical devices Type: Customer information

Product group Dressings / Pads - surgical sutures, vascular loops etc.
Reference 07899/13

Recall of certain lots of the Inzii 12/15mm retrieval system, Applied Medical PDF, 415KB, File does not meet accessibility standards Date: 20. January 2014 Topics: Medical devices Type: Customer information

Product group Optics / Precision engineering - precision instruments for gastrointestinal and urological endoscopy and hysteroscopy
Reference 06570/13

Corrective action for BacT/Alert PF PLUS and FA Plus Culture Bottles, bioMérieux PDF, 120KB, File does not meet accessibility standards Date: 20. January 2014 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - microbiological products
Reference 07132/13

Corrective action for HbA1c liquidirect, Human PDF, 46KB, File does not meet accessibility standards Date: 17. January 2014 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 07670/13

Lot Recall of suprapubic catheter kits, Urotech GmbH PDF, 93KB, File does not meet accessibility standards Date: 17. January 2014 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - catheters
Reference 06872/13

Safety Notice for the Precision 500D, Precision MPI and Precision RXI X-ray imaging systems, GE Healthcare PDF, 58KB, File does not meet accessibility standards Date: 17. January 2014 Topics: Medical devices Type: Customer information

Product group Radiological technology - stationary radiological equipment
Reference 00062/14

Lot Recall of Sengstaken-Blakemore tube and ENDOGUIDE Guide wire, Teleflex PDF, 355KB, File does not meet accessibility standards Date: 17. January 2014 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - probes
Reference 07969/13

Urgent Safety Notice for the Hemolung Cartridge Kit, ALung Technologies PDF, 1MB, File does not meet accessibility standards Date: 17. January 2014 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 07383/13

Safety Notice for the Radiation Therapy Simulators of type SimView™ NT, Siemens Healthcare PDF, 53KB, File does not meet accessibility standards Date: 17. January 2014 Topics: Medical devices Type: Customer information

Product group Radiotherapy / Radiation protection - radiotherapy simulator
Reference 08001/13

Recall of Laparoscopic BiClamp handles, ERBE Elektromedizin GmbH PDF, 86KB, File does not meet accessibility standards Date: 17. January 2014 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrotherapy
Reference 00060/14

Urgent Safety Notice for the Philips Expression Information Portal (IP5), Philips Healthcare PDF, 108KB, File does not meet accessibility standards Date: 17. January 2014 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrodiagnostics
Reference 07618/13

Important Safety Notice for the XIO RTP System, IMPAC Medical Systems PDF, 136KB, File does not meet accessibility standards Date: 16. January 2014 Topics: Medical devices Type: Customer information

Product group Radiotherapy / Radiation protection - radiotherapy treatment planning systems
Reference 07967/13

Corrective action for Total IgE on Immulite® 1000, Immulite® 2000 and Immulite® 2000 XPi, Siemens PDF, 100KB, File does not meet accessibility standards Date: 16. January 2014 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - immunological products
Reference 00017/14