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Urgent field safety notice for Afinion CRP, Alere Technologies AS PDF, 117KB, File does not meet accessibility standards Date: 17. August 2016 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - immunological products
Reference 06637/16

Urgent field safety notice for ADVIA Centaur / XP / XPT / CP, Siemens Healthcare Diagnostics Inc. PDF, 74KB, File does not meet accessibility standards Date: 17. August 2016 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - immunological products
Reference 06891/16

Urgent field safety notice for ADVIA Centaur / XP / XPT / CP, Siemens Healthcare Diagnostics Inc. PDF, 173KB, File does not meet accessibility standards Date: 17. August 2016 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 06970/16

Lot recall of Metalline products with metal needles, Lohmann & Rauscher GmbH & Co. KG PDF, 61KB, File does not meet accessibility standards Date: 17. August 2016 Topics: Medical devices Type: Customer information

Product group Dressings / Pads - dressings
Reference 04866/16

Urgent field safety notice for Puritan Bennett 980 Series Ventilator System, Covidien Deutschland GmbH PDF, 85KB, File does not meet accessibility standards Date: 17. August 2016 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply
Reference 00397/16

Urgent field safety notice for ProcedurePak kits and trays containing umbilical clamps (IFKR21 & 2305123-00), Mölnlycke Health Care PDF, 109KB, File does not meet accessibility standards Date: 17. August 2016 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - gynaecology
Reference 06771/16

Urgent field safety notice for LIFEPAK CR Plus AED and LIFEPAK EXPRESS AED, Physio Control UK Sales Ltd. PDF, 132KB, File does not meet accessibility standards Date: 08. August 2016 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrotherapy
Reference 06765/16

Urgent field safety notice for the modification of the gantry base drive wheel assembly Precise series Linac / Product: Digital Accelerator, Elekta Ltd. PDF, 81KB, File does not meet accessibility standards Date: 08. August 2016 Topics: Medical devices Type: Customer information

Product group Radiotherapy / Radiation protection - radiation facilites with accelerators for teletherapy
Reference 06755/16

Urgent field safety notice for BK Virus R-gene ® Real-time Detection an Quantification Kit (ref 69-013B), bioMerieux SA PDF, 291KB, File does not meet accessibility standards Date: 08. August 2016 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - microbiological products
Reference 06691/16

Urgent field safety notice for Etest ® Colistin CO256 WW (Ref. 537300 / 537308), BioMerieux SA PDF, 306KB, File does not meet accessibility standards Date: 08. August 2016 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - microbiological products
Reference 06727/16

Urgent field safety notice for EnVeo R Delivery Catheter System, Medtronic PDF, 56KB, File does not meet accessibility standards Date: 05. August 2016 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - catheters
Reference 06664/16

Lot recall of Sinaqua Dermal Glove / Sinaqua Wipe / Easyderm Glove, Welcare lndustries S.p.A. / medi GmbH & Co. KG PDF, 302KB, File does not meet accessibility standards Date: 04. August 2016 Topics: Medical devices Type: Customer information

Product group General equipment for medical treatment - cleaning / disinfection / sterilisation
Reference 06269/16

Lot recall of blood donor set 4-BB-SK-100-E, Fresenius Kabi Deutschland GmbH PDF, 160KB, File does not meet accessibility standards Date: 04. August 2016 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - equipment for collecting blood products and peripheral stem cells
Reference 06612/16

Urgent field safety notice for dynamic seat shell system with undercarriage AKTIVLINE, interco GmbH PDF, 43KB, File does not meet accessibility standards Date: 03. August 2016 Topics: Medical devices Type: Customer information

Product group Orthopaedic / Rehabilitation technology - mobility aids
Reference 06570/16

Urgent field safety notice for G-scan Brio Magnetic Resonance System, Esaote PDF, 328KB, File does not meet accessibility standards Date: 03. August 2016 Topics: Medical devices Type: Customer information

Product group Electromedical fields - equipment for MR tomography
Reference 05710/16

Urgent field safety notice for MylabTwice, Esaote PDF, 184KB, File does not meet accessibility standards Date: 03. August 2016 Topics: Medical devices Type: Customer information

Product group Ultrasonics - ultrasonic diagnostic equipment
Reference 05703/16

Urgent field safety notice for CADstream versions earlier than 5.2.6, Merge Healthcare PDF, 121KB, File does not meet accessibility standards Date: 03. August 2016 Topics: Medical devices Type: Customer information

Product group Medical data processing (software) - software for MR tomography
Reference 05483/16

Urgent field safety notice for CADstream, Merge Healthcare PDF, 122KB, File does not meet accessibility standards Date: 03. August 2016 Topics: Medical devices Type: Customer information

Product group Medical data processing (software) - software for MR tomography
Reference 05482/16

Batch recall of Hermann Gastrostomy Dressing Set, Fresenius Kabi AG PDF, 27KB, File does not meet accessibility standards Date: 03. August 2016 Topics: Medical devices Type: Customer information

Product group Dressings / Pads - dressings
Reference 06613/16

Urgent field safety notice for Silver Tracheostomy Tubes, Phoenix Surgical lnstruments PDF, 547KB, File does not meet accessibility standards Date: 03. August 2016 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - anaesthesia and medical gas supply
Reference 06373/16

Urgent field safety notice for syngo RT Oncologist, Siemens Healthcare GmbH PDF, 25KB, File does not meet accessibility standards Date: 02. August 2016 Topics: Medical devices Type: Customer information

Product group Radiotherapy / Radiation protection - radiotherapy treatment planning systems
Reference 06579/16

Lot recall of Sterile RENASYS Transparent Film, Smith & Nephew Inc. PDF, 428KB, File does not meet accessibility standards Date: 02. August 2016 Topics: Medical devices Type: Customer information

Product group Dressings / Pads - dressings
Reference 06340/16

Urgent field safety notice for sterile Introducer Needle 18G, Kimal plc PDF, 287KB, File does not meet accessibility standards Date: 02. August 2016 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - syringes and cannulas
Reference 06549/16

Urgent field safety notice for Eye Station and Eye Care PACS, Merge Healthcare PDF, 132KB, File does not meet accessibility standards Date: 02. August 2016 Topics: Medical devices Type: Customer information

Product group Radiological technology - auxiliary equipment and supplies for radiology / nuclear medicine
Reference 05465/16

Urgent field safety notice for syngo RT Therapist, Siemens Healthcare GmbH PDF, 39KB, File does not meet accessibility standards Date: 02. August 2016 Topics: Medical devices Type: Customer information

Product group Radiotherapy / Radiation protection - radiotherapy treatment planning systems
Reference 06553/16

Lot recall of mini²SKY gingiva former, bredent medical GmbH & Co. KG PDF, 197KB, File does not meet accessibility standards Date: 02. August 2016 Topics: Medical devices Type: Customer information

Product group Dental products - dental implants
Reference 06173/16

Lot recall of Lotus Valve System, Boston Scientific International S.A. PDF, 143KB, File does not meet accessibility standards Date: 02. August 2016 Topics: Medical devices Type: Customer information

Product group Non-active implants - cardiac surgery
Reference 06527/16

Urgent Field Safety Notice for patient table (Ysio / Ysio Max / Multix Fusion), Siemens Healthcare GmbH PDF, 256KB, File does not meet accessibility standards Date: 01. August 2016 Topics: Medical devices Type: Customer information

Product group Radiological technology - stationary radiological equipment
Reference 06545/16

Urgent field safety notice for Laerdal Suction Unit (LSU) with LSU NiMH Battery, Laerdal Medical AS PDF, 371KB, File does not meet accessibility standards Date: 01. August 2016 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 06523/16

Urgent field safety notice for TrueBeam Radiotherapy Delivery System with AlignRT, Varian Medical Systems PDF, 94KB, File does not meet accessibility standards Date: 01. August 2016 Topics: Medical devices Type: Customer information

Product group Radiotherapy / Radiation protection - radiation facilites with accelerators for teletherapy
Reference 05676/16