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Urgent Field Safety Notice for systems ADVIA Centaur / Dimension Vista / IMMULITE, Siemens Healthcare Diagnostics Inc. PDF, 50KB, File does not meet accessibility standards Date: 12. February 2016 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - immunological products
Reference 00340/16

Urgent field safety notice for PFA-100 System / INNOVANCE PFA-200 System, Siemens Healthcare Diagnostics Products GmbH PDF, 25KB, File does not meet accessibility standards Date: 11. February 2016 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - haematological, histological and cytological products
Reference 09755/15

Urgent Field Safety Notice for Urinary Metanephrines by HPLC, Bio-Rad Laboratories GmbH PDF, 87KB, File does not meet accessibility standards Date: 11. February 2016 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - immunological products
Reference 07281/15

Urgent Field Safety Notice for ARIETTA 60 & 70 series, Hitachi Aloka Medical Ltd. PDF, 120KB, File does not meet accessibility standards Date: 11. February 2016 Topics: Medical devices Type: Customer information

Product group Ultrasonics - ultrasonic diagnostic equipment
Reference 00019/16

Lot recall for Klarsichtbeutel mit & ohne Falte / Klarsichtschlauch mit & ohne Falte, Roeser Medical GmbH PDF, 170KB, File does not meet accessibility standards Date: 11. February 2016 Topics: Medical devices Type: Customer information

Product group General equipment for medical treatment - cleaning / disinfection / sterilisation
Reference 00023/16

Safety notice for Giraffe rollators, Mobilex A/S PDF, 70KB, File does not meet accessibility standards Date: 11. February 2016 Topics: Medical devices Type: Customer information

Product group Orthopaedic / Rehabilitation technology - daily living aids
Reference 07973/15

Urgent field safety notice for guide wire J6-FC-160-063 / sterile, EPflex Feinwerktechnik GmbH PDF, 3MB, File does not meet accessibility standards Date: 11. February 2016 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - catheters
Reference 00030/16

Urgent Field Safety Notice for EliA SmDp Well, Art. No. 14-5624-01, Phadia AB / Thermo Fisher Scientific PDF, 165KB, File does not meet accessibility standards Date: 11. February 2016 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - immunological products
Reference 00164/16

Urgent field safety notice for blood bag filter LCRD2, Macopharma PDF, 368KB, File does not meet accessibility standards Date: 11. February 2016 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - equipment for collecting blood products and peripheral stem cells
Reference 09129/15

Urgent field safety notice for PT screening assay with Dade Innovin on BCS / BCS XP Automated Blood Coagulation Analyzer, Siemens Healthcare Diagnostics Products GmbH PDF, 42KB, File does not meet accessibility standards Date: 11. February 2016 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 09760/15

Urgent field safety notice for sterile Inspire Custom Pack Revision 02, Cardiac Surgery BU / LivaNova / Sorin Group Italia S.r.l. PDF, 86KB, File does not meet accessibility standards Date: 11. February 2016 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 00043/16

Urgent field safety notice for defibrillator FRED easy, SCHILLER MEDICAL SAS PDF, 150KB, File does not meet accessibility standards Date: 11. February 2016 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrotherapy
Reference 00104/16

Lot recall of sterile packaging of Guide Wire(s), K-Wire(s) and Intramedullary Pin Metaizeau, Stryker Trauma GmbH PDF, 418KB, File does not meet accessibility standards Date: 11. February 2016 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - catheters
Reference 09758/15

Batch recall of BEAVER 4.0 mm Banana Blade, Smith & Nephew Inc. PDF, 87KB, File does not meet accessibility standards Date: 11. February 2016 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - bone surgery
Reference 00057/16

Lot recall of ATB Densitometer control Kit (reference 15512), bioMérieux SA PDF, 149KB, File does not meet accessibility standards Date: 11. February 2016 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - microbiological products
Reference 08208/15

Batch recall of Hydrophilic Acrylic Single Use IOL system packs, Rayner lntraocular Lenses Limited PDF, 284KB, File does not meet accessibility standards Date: 11. February 2016 Topics: Medical devices Type: Customer information

Product group Non-active implants - special implants
Reference 00008/16

Urgent Field Safety Notice for ImmunoCAP Specific IgG/IgG4 i1 Control H, ImmunoDiagnostics / Thermo Fisher Scientific PDF, 145KB, File does not meet accessibility standards Date: 05. February 2016 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - immunological products
Reference 00066/16

Lot recall of Extraction Screw for PFNA Blade, DePuy Synthes / Synthes GmbH PDF, 330KB, File does not meet accessibility standards Date: 05. February 2016 Topics: Medical devices Type: Customer information

Product group Medical instruments for use in humans - bone surgery
Reference 00033/16

Urgent Field Safety Notice for TruLight 3000, TruLight 5000, iLED 3, iLED 5 and TruVidia Lighting and Video Systems, TRUMPF Medizin Systeme GmbH + Co. KG PDF, 185KB, File does not meet accessibility standards Date: 05. February 2016 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 00029/16

Urgent Field Safety Notice for 9131-001 Defibrillation Electrodes Lot No. 141125-02 in Powerheart G3 9300A, 9300E, 9300P, 9390A, and 9390E AEDs, Cardiac Science PDF, 92KB, File does not meet accessibility standards Date: 05. February 2016 Topics: Medical devices Type: Customer information

Product group Medical electronics / Electromedical devices - electrotherapy
Reference 09725/15

Recall for ala purple, alamedics GmbH & Co. KG PDF, 136KB, File does not meet accessibility standards Date: 05. February 2016 Topics: Medical devices Type: Customer information

Product group ophthalmological technology - other medical devices for ophthalmological purposes
Reference 09720/15

Urgend Field Safety Notice for Double Airway Splint I and II, Websinger GmbH PDF, 252KB, File does not meet accessibility standards Date: 05. February 2016 Topics: Medical devices Type: Customer information

Product group Non-active implants - bone surgery
Reference 07732/15

Advisory Notice for BD syringes included in procedure packs, ArcRoyal PDF, 266KB, File does not meet accessibility standards Date: 05. February 2016 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - syringes and cannulas
Reference 09131/15

Field safety notice for Compat Go Enteral Feeding Sets with ENFit connectors, Nestlé Health Science S.A., PDF, 368KB, File does not meet accessibility standards Date: 05. February 2016 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - infusion technology
Reference 09774/15

Urgent field safety notice for IDS-iSYS Multi-Discipline Automated System, IDS France / Immunodiagnostic Systems Limited PDF, 70KB, File does not meet accessibility standards Date: 05. February 2016 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - equipment / products for clinical chemistry
Reference 09719/15

Important corrective action for ADVIA Centaur / Centaur XP / Centaur XPT / Centaur CP / Centaur Systems PSA Assay High Dose Hook Effect, Siemens Healthcare Diagnostics Inc. PDF, 65KB, File does not meet accessibility standards Date: 05. February 2016 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - immunological products
Reference 00037/16

Important corrective action for 96 DEEPWELL PLATE 2ML on VERSANT kPCR Sample Preparation and Tissue Preparation Systems, Siemens Healthcare Diagnostics Inc. PDF, 21KB, File does not meet accessibility standards Date: 05. February 2016 Topics: Medical devices Type: Customer information

Product group In-vitro diagnostics - instruments, apparatuses and systems
Reference 00036/16

Lot recall of BT2000 (SKU 014613) and CPT2000 (SKU 014623) Manifold Kits, ACIST Medical Systems Inc. / ACIST Europe BV PDF, 48KB, File does not meet accessibility standards Date: 05. February 2016 Topics: Medical devices Type: Customer information

Product group Injections / Infusions / Transfusions / Dialysis - infusion technology
Reference 09753/15

Urgent Field Safety Notice for Nebulizer NebuTech Model Number 8960-7-50, Salter Labs / Henleys Medical Supplies Ltd. PDF, 134KB, File does not meet accessibility standards Date: 05. February 2016 Topics: Medical devices Type: Customer information

Product group Physical therapy - inhalation therapy
Reference 05354/15

Important Field Safety Notice for Medical head lamp BT-410, Bistos Co. Ltd. PDF, 68KB, File does not meet accessibility standards Date: 05. February 2016 Topics: Medical devices Type: Customer information

Product group Surgical equipment/ Anaesthesia - surgical equipment
Reference 09015/15