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Possible inadvertent deletion of accessory elements (including dynamic MLC) in VARIS Vision, Varian medical systems PDF, 1MB, File does not meet accessibility standards Date: 17. June 2011 Topics: Medical devices Type: Customer information

Product group Radiotherapy / Radiation protection
Reference 02252/11

Collision risk when lowering table height of Ysio, Siemens Healthcare PDF, 170KB, File does not meet accessibility standards Date: 16. June 2011 Topics: Medical devices Type: Customer information

Product group Radiological technology
Reference 02257/11

Lot Recall for SafeSheath Sealing Adapter, CPS SafeSheath Sealing Adapter, GE Healthcare PDF, 49KB, File does not meet accessibility standards Date: 16. June 2011 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis
Reference 04848/10

Recall of SPOT-Light HER2 CISH Kit (Lot-No. 849398A), Life Technologies PDF, 592KB, File does not meet accessibility standards Date: 15. June 2011 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics
Reference 01945/11

Problem with MLC and field size changes to XiO plans, Elekta CMS software PDF, 76KB, File is accessible Date: 15. June 2011 Topics: Medical devices Type: Customer information

Product group Radiotherapy / Radiation protection
Reference 02896/10

Problem of undesirable behavior in specific reporting workflow in syngo Dynamics 9.0, Siemens Healthcare PDF, 71KB, File does not meet accessibility standards Date: 15. June 2011 Topics: Medical devices Type: Customer information

Product group Radiological technology
Reference 02331/11

Safety Notice for aortic root bioprosthesis TLPB-A Supra 21, 23, 25 mm, Freelife PDF, 56KB, File does not meet accessibility standards Date: 15. June 2011 Topics: Medical devices Type: Customer information

Product group Non-active implants
Reference 01222/11

Safety Notice for Ru-106 Ophthalmic Applicators, IBt Bebig PDF, 601KB, File does not meet accessibility standards Date: 15. June 2011 Topics: Medical devices Type: Customer information

Product group Radiotherapy / Radiation protection
Reference 01658/11

Software issue regarding iBGStar® blood glucose meter, AgaMatrix Inc. PDF, 21KB, File does not meet accessibility standards Date: 07. June 2011 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics
Reference 02447/11

Field Safety Notice concerning potential risk of false measurement results of ACUSON S2000, Siemens PDF, 832KB, File does not meet accessibility standards Date: 07. June 2011 Topics: Medical devices Type: Customer information

Product group Ultrasonics
Reference 01922/11

Safety Notice concerning secondary Dose Calculation Error under the MLC leaves (Monaco), Elekta CMS Software PDF, 49KB, File does not meet accessibility standards Date: 06. June 2011 Topics: Medical devices Type: Customer information

Product group Radiotherapy / Radiation protection
Reference 01606/11

Update of cardioPAT® Manual for Leak Detection, Haemonetics PDF, 64KB, File does not meet accessibility standards Date: 06. June 2011 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis
Reference 00390/11

Safety Notice for Spacelabs Medical Vital Signs Monitor élance, Spacelabs Healthcare PDF, 34KB, File does not meet accessibility standards Date: 06. June 2011 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices
Reference 02318/11

Recall of ANA.NOVA® MII neck, Intraplant GmbH PDF, 42KB, File does not meet accessibility standards Date: 06. June 2011 Topics: Medical devices Type: Customer information

Product group Non-active implants
Reference 02408/11

Corrective action for the Vitek 2 Piperacillin/Tazobactam test, Biomerieux PDF, 26KB, File does not meet accessibility standards Date: 06. June 2011 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics
Reference 01656/11

Corrective action for HemoCue Glucose 201 Microcuvettes, HemoCue PDF, 255KB, File does not meet accessibility standards Date: 03. June 2011 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics
Reference 02426/11

Recall of HAV Ab-Reagent for use on Access Immunoassay Systems, Beckman Coulter PDF, 273KB, File does not meet accessibility standards Date: 03. June 2011 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics
Reference 02398/11

Urgent Safety Notice for the HgbPro Professional Hemoglobin Testing System, ITC PDF, 224KB, File does not meet accessibility standards Date: 03. June 2011 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics
Reference 02311/11

Recall for the NexGen® Complete Knee Solution Stemmed & Rotating Hinge Knee Tibial Broach Impactors, Zimmer PDF, 546KB, File does not meet accessibility standards Date: 01. June 2011 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans
Reference 01583/10

Recall of the Silikon-Penrose Kapillar Drain, Roeser Medical GmbH PDF, 322KB, File does not meet accessibility standards Date: 01. June 2011 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis
Reference 02218/11

Safety Notice for the Optical Guidance Platform, Varian medical systems PDF, 208KB, File does not meet accessibility standards Date: 01. June 2011 Topics: Medical devices Type: Customer information

Product group Radiotherapy / Radiation protection
Reference 02177/11

Corrective action for Vitros Chemistry Products VALP Reagent, Ortho Clinical Diagnostics PDF, 84KB, File does not meet accessibility standards Date: 01. June 2011 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics
Reference 02207/11

Recall for RT-Plus Modular Stepped Drill and RT-Plus Modular Tibial Drill Guide, Smith & Nephew Orthopaedics PDF, 109KB, File does not meet accessibility standards Date: 01. June 2011 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans
Reference 02371/11

Safety Notice for the EOS System / sterEOS Workstation, EOS imaging PDF, 602KB, File does not meet accessibility standards Date: 31. May 2011 Topics: Medical devices Type: Customer information

Product group Radiological technology
Reference 01720/11

Recall of implantable pulse generators for neurostimulation EON MINI and BRIO, St. Jude Medical PDF, 62KB, File does not meet accessibility standards Date: 31. May 2011 Topics: Medical devices Type: Customer information

Product group Active implantable medical devices
Reference 02317/11

Safety Corrective Action concerning FLOW-i anaesthesia system, Maquet PDF, 333KB, File does not meet accessibility standards Date: 31. May 2011 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia
Reference 02231/11

Safety Notice for the Moore Medical Alcohol Prep Pads copackaged in Grael PSG Starter Kit, Compumedics Germany GmbH PDF, 99KB, File does not meet accessibility standards Date: 31. May 2011 Topics: Medical devices Type: Customer information

Product group Dressings / Pads
Reference 01828/11

Corrective action for Synchron Systems Calibrator 1, Beckman Coulter PDF, 49KB, File does not meet accessibility standards Date: 30. May 2011 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics
Reference 02212/11