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Recall and updated instructions for use for Lifetech CeraFlex Atrial Septal Defect (ASD) Occluder, Lifetech Scientific (Shenzhen) Co. Ltd. PDF, 864KB, File does not meet accessibility standards Date: 01. April 2016 Topics: Medical devices Type: Customer information

Product group Non-active implants - cardiac surgery
Reference 01918/16

Field safety notice for intraocular lenses CT ASPHINA 404V and CT ASPHINA 409MV, Carl Zeiss Meditec AG PDF, 153KB, File does not meet accessibility standards Date: 31. March 2016 Topics: Medical devices Type: Customer information

Product group Non-active implants - special implants
Reference 02604/16

Lot recall of SPOTCHEM II Glucose / SPOTCHEM II PANEL-1 und SPOTCHEM II PANEL-V, ARKRAY Factory Inc. PDF, 507KB, File does not meet accessibility standards Date: 31. March 2016 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 00909/16

Urgent field safety notice for M. HINTON 2 SHEEP BLOOD 90 20PL- (Ref. 43321), bioMérieux SA PDF, 375KB, File does not meet accessibility standards Date: 31. March 2016 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - microbiological products
Reference 02598/16

Urgent field safety information for Leg Holder HEAVY T pads, TRUMPF Medizin Systeme GmbH + Co. KG PDF, 57KB, File does not meet accessibility standards Date: 31. March 2016 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 01595/16

Lot recall of ELISI0-19H, Nipro Europe NV PDF, 3MB, File does not meet accessibility standards Date: 30. March 2016 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - dialysis technology
Reference 02546/16

Lot recall of Affected Device(s): I.V. Administration Sets with ChemoLock Port, ICU Medical Inc. PDF, 497KB, File does not meet accessibility standards Date: 29. March 2016 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - infusion technology
Reference 01970/16

Lot recall of Silicone catheter/ Type: 2-way standard/ Size: 14Fr/ Lot No.: 20150525, Jiangsu Suyun Medical Materials Co. Ltd. PDF, 18KB, File does not meet accessibility standards Date: 24. March 2016 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - catheters
Reference 10139/15

Urgend field safety notice for VERSANT kPCR Molecular System Sample Preparation, Siemens Healthcare Diagnostics Inc. PDF, 24KB, File does not meet accessibility standards Date: 23. March 2016 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - instruments, apparatuses and systems
Reference 02345/16

Urgent field safety notice for product / detection kit combinations, Leica Biosystems Newcastle Ltd. PDF, 264KB, File does not meet accessibility standards Date: 23. March 2016 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - immunological products
Reference 00321/16

Urgent field safety notice for monitor assembly with HASEKE suspension arm, MAVIG GmbH PDF, 141KB, File does not meet accessibility standards Date: 23. March 2016 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 01022/16

Urgent Field Safety Notice for Ysio systems with fixed detector in wall stand with software version VC10, Siemens AG PDF, 165KB, File does not meet accessibility standards Date: 22. March 2016 Topics: Medical devices Type: Customer information

Product group Radiological technology - stationary radiological equipment
Reference 05415/14

Lot recall for Covidien Emprint Percutaneous Antenna with Thermosphere Technology, Medtronic PDF, 609KB, File does not meet accessibility standards Date: 22. March 2016 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrotherapy
Reference 01777/16

Urgent Field Safety Notice for KV-5 Suction Pump / Patient Connecting Tube MAJ-103, Olympus / KeyMed (Medical & lndustrial Equipment) Ltd. PDF, 109KB, File does not meet accessibility standards Date: 22. March 2016 Topics: Medical devices Type: Customer information

Product group Optics / Precision engineering - endoscopes
Reference 01320/16

Urgent field safety notice for VERION Reference Unit (Vision Planner), Alcon Eye Care UK Limited PDF, 435KB, File does not meet accessibility standards Date: 22. March 2016 Topics: Medical devices Type: Customer information

Product group ophthalmological technology - equipment for ophthalmological diagnostics
Reference 01963/16

Urgent field safety notice for natural rubber products / Papoose cervical orthoses for babies, Össur PDF, 244KB, File does not meet accessibility standards Date: 22. March 2016 Topics: Medical devices Type: Customer information

Product group Orthopaedic / Rehabilitation technology - orthoses
Reference 02100/16

Lot recall for GlideScope Video Laryngoscope Titanium Single-Use (SU) Blades, Verathon Incorporated / VERATHON MEDICAL (EUROPE) B.V. PDF, 345KB, File does not meet accessibility standards Date: 22. March 2016 Topics: Medical devices Type: Customer information

Product group Optics / Precision engineering - medical microscopes (does not incude laboratory microscopes)
Reference 01215/16

Urgent Field Safety Notice for Juno DRF, Philips Medical Systems PDF, 58KB, File does not meet accessibility standards Date: 22. March 2016 Topics: Medical devices Type: Customer information

Product group Radiological technology - stationary radiological equipment
Reference 02037/16

Urgent field safety notice for TOPAZ MicroDebriders, Smith & Nephew Inc. PDF, 69KB, File does not meet accessibility standards Date: 22. March 2016 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrotherapy
Reference 01996/16

Urgent Field Safety Notice for Monopolar Instruments / Bipolar Instrument Handle CEV669E, Integra MicroFrance SAS PDF, 118KB, File does not meet accessibility standards Date: 22. March 2016 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrotherapy
Reference 01985/16

Lot recall of Intra-Aortic Balloon Catheter Kits and Percutaneous Insertion Kits, Teleflex / Arrow International Inc. PDF, 111KB, File does not meet accessibility standards Date: 22. March 2016 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - catheters
Reference 01613/16

Urgent field safety notice for Artis zee systems with generator A100Plus / Artis zeego systems with software version VC21 B, Siemens Healthcare GmbH PDF, 75KB, File does not meet accessibility standards Date: 22. March 2016 Topics: Medical devices Type: Customer information

Product group Radiological technology - radiological equipment for vascular diagnostics
Reference 01961/16

Urgent field safety notice for da Vinci Si and Xi Touchpad Compact Flash Card, Intuitive Surgical Sàrl PDF, 307KB, File does not meet accessibility standards Date: 22. March 2016 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 01967/16

Urgent Field Safety Notice for Double joint struts, OR Adapter, OR-Extension (manufactured prior to September 2004), TRUMPF Medizin Systeme GmbH + Co. KG PDF, 60KB, File does not meet accessibility standards Date: 22. March 2016 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 01880/16

Lot recall of ACCUFORCE PTCA Dilatation Catheter (φ 2.5 mm), Terumo Corporation / Terumo Europe NV PDF, 207KB, File does not meet accessibility standards Date: 22. March 2016 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - catheters
Reference 01962/16

Batch recall for Endobon Xenograft Granules, Biomet France SARL / BIOMET 3i Deutschland GmbH PDF, 114KB, File does not meet accessibility standards Date: 22. March 2016 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 00841/16

Urgent field safety notice for Virage OCT Spinal Fixation System Closure Caps (item number 07.01728.001), Zimmer Biomet Spine PDF, 1MB, File does not meet accessibility standards Date: 22. March 2016 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 01987/16

Lot recall of Cranial Screw PlusDrive ø 1.6 mm, self-drilling, L 3 mm, DePuy Synthes / Synthes GmbH PDF, 105KB, File does not meet accessibility standards Date: 22. March 2016 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 01928/16

Urgent field safety notice for MicroScan LabPro Information Manager System, Beckman Coulter PDF, 558KB, File does not meet accessibility standards Date: 21. March 2016 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 01721/16

Urgent Field Safety Notice for FT4 RIA Tracer, BRAHMS GmbH PDF, 167KB, File does not meet accessibility standards Date: 21. March 2016 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - immunological products
Reference 01187/16