Événements

Nom Date Date de mise en oeuvre Pays Source
Rappel de ADVIA Chemistry Systems (using Trinder and Trinder-like assays). An in vitro diagnostic medical device (IVD) Assays affected: Cholesterol_2, Cholesterol_c, Enzymatic Creatinine_2, Glucose Oxidase, Triglycerides_2, Triglycerides_2 concentrated, Uric Acid, Uric Acid concentrated reagents, Fructosamine.LDL Cholesterol Direct, Direct HDL Cholesterol, Glucose Oxidase, Concentrated reagents. 2016-03-24 Australia DHTGA
Rappel de Dimension and Dimension Vista Clinical Chemistry Systems. An in vitro diagnostic medical device (IVD) Assays affected: Triglycerides, Enzymatic Creatinine, Automated HDL Cholesterol, Uric Acid and HDL Cholesterol 2016-03-24 Australia DHTGA
Rappel de MobileDiagnost wDR Rel1 and 2 (general purpose mobile digital x-ray system) 2016-03-24 Australia DHTGA
Rappel de TCAutomation System with Thermo Scientific Recapper (used with VITROS Automation Solutions). An in vitro diagnostic medical device (IVD) 2016-03-24 Australia DHTGA
Rappel de Acuson SC200 ultrasound systems 2016-03-24 Australia DHTGA
Rappel de Fetch 2 Aspiration Catheter (used for the removal of fresh, soft emboli and thrombi from vessels in the peripheral and coronary vasculature) 2016-03-24 Australia DHTGA
Rappel de Acuson 2000 ultrasound system (with structural foam core). 2016-03-24 Australia DHTGA
Rappel de ME DPHC 0001 deltastream HC, 230V (Cardiopulmonary bypass system heating/cooling unit) 2016-04-07 Australia DHTGA
Rappel de Dimension Vista 500/ Dimension Vista 1500 Intelligent Lab Systems, software versions V. 3.6.1 SP1 or V. 3.6.2. An in vitro diagnostic medical device (IVD) 2016-03-30 Australia DHTGA
Rappel de Military Trauma & Haemorrhage Wound Dressing, size 10 x 17cm 2016-04-14 Australia DHTGA
Rappel de ID Anti-N and ID Anti-M/N. An in vitro diagnostic medical device (IVD) 2016-04-07 Australia DHTGA
Rappel de Artis zee Systems with generator A100Plus or Artis zeego Systems with software version VC21B. (fluoroscopic angiographic x-ray systems) 2016-03-31 Australia DHTGA
Rappel de Vaxcel and Xcela PICC with PASV Valve Technology/Kits, BioFlo PICC Triple Lumen with Endexo and PASV Valve Technology/Kits 2016-04-08 Australia DHTGA
Rappel de AutoSPECT Pro Reconstruction application on Extended Brilliance Workplace NM software version 2.0(used to process, analyse, and display medical images/data obtained from other diagnostic devices, including gamma cameras) 2016-04-06 Australia DHTGA
Rappel de AutoSPECT Pro Reconstruction application on Intellispace Portal software versions 5.0, 6.0 and 7.0 2016-04-01 Australia DHTGA
Rappel de 10mm Direct Drive Clip Applier (Used for ligation of tubular structures or vessels in laparoscopic and general surgical procedures) 2016-04-05 Australia DHTGA
Rappel de CELL-DYN Emerald Cleaner. An in vitro diagnostic medical device (IVD) 2016-04-05 Australia DHTGA
Rappel de EZee-Nest Insert Cups used with ADVIA Centaur CP. An in vitro diagnostic medical device (IVD) 2016-04-05 Australia DHTGA
Rappel de ARCHITECT Estradiol Reagent. An in vitro diagnostic medical device (IVD) 2016-04-05 Australia DHTGA
Rappel de PneumoSure XL High Flow Insufflator (Used to create a cavity by insufflating CO2 during diagnostics and/or therapeutic laparoscopy) 2016-04-04 Australia DHTGA
Rappel de Oxoid Antimicrobial Susceptibility Testing Discs - Ticarcillin/Clavulanic Acid (TIM85 Timetin). An in vitro diagnostic medical device (IVD) 2016-04-05 Australia DHTGA
Rappel de Mizuho General Purpose Operating Table 2016-04-11 Australia DHTGA
Rappel de Gene Amplification Reagent – Lynoamp BC. An in vitro diagnostic medical device. 2016-04-05 Australia DHTGA
Rappel de Somatom Force with software versions, VA50A and VA50A_SP2 with paediatric kernel Hp38 (Computed Tomography (CT) system) 2016-04-05 Australia DHTGA
Rappel de Aisys and Aisys CS2 Anaesthesia machines with the optional Vacuum Suction Function 2016-04-08 Australia DHTGA