Événements

Nom Date Date de mise en oeuvre Pays Source
Rappel de 2-Way Foley Catheters and 2-Way Council Tip Foley Catheters (used for urinary drainage)Distributed between June 2013 to June 2015 2015-12-22 Australia DHTGA
Rappel de Oxylog Transport Ventilator 2015-12-23 Australia DHTGA
Rappel de 96 Deep Well Plate 2mL (used on the VERSANT kPCR Sample Preparation and Tissue Preparation System) 2015-12-22 Australia DHTGA
Rappel de Coulter S-CAL Calibrator Kits used on the Unicel DxH 800, DxH 600, LH 750 and LH 780 Systems. 2015-12-23 Australia DHTGA
Rappel de HeartWare HVAD Controller AC Adapter and HeartWare HVAD Battery 2016-01-07 Australia DHTGA
Rappel de VariAx 2 3.5 mm screws Catalogue Numbers: 657308 – 657332 and 657408 – 657432 2015-12-24 Australia DHTGA
Rappel de da Vinci Xi instrument & accessoriesAffected instruments:0 deg, 8mm Endoscope, IS4000 2015-12-24 Australia DHTGA
Rappel de PFNA Nails (used during internal fixation surgery) 2015-12-24 Australia DHTGA
Rappel de API ZYM B. An in vitro diagnostic medical device (IVD) 2015-12-24 Australia DHTGA
Rappel de Optima XR200amx, Optima XR220amx and Brivo XR285amx X-ray imaging systems 2016-01-04 Australia DHTGA
Rappel de Guide Wires and K-Wires for T2 and Gamma Nailing Systems 2016-01-04 Australia DHTGA
Rappel de Mavig Monitor suspension arms manufactured before January 2009 (used with x-ray fluoroscopic imaging systems) Installed on INNOVA 2100, 3100 fluoroscopic imaging systems. 2016-01-04 Australia DHTGA
Rappel de ADVIA Centaur PSA 100 test kit and 500 test kit. An in vitro diagnostic medical device (IVD) 2016-01-06 Australia DHTGA
Rappel de EliA SmDP Well 2016-01-05 Australia DHTGA
Rappel de ImmunoCAP Specific IgG/IgG4 i1 Control H. An in vitro diagnostic device (IVD) 2016-01-15 Australia DHTGA
Rappel de AQURE data management system 2016-01-06 Australia DHTGA
Rappel de VITROS Chemistry System. An in vitro diagnostic device (IVD) 2016-01-07 Australia DHTGA
Rappel de INNOVANCE PFA P2Y. An in vitro diagnostic device (IVD) 2016-01-07 Australia DHTGA
Rappel de Cook Beacon Tip Angiography Catheters Beacon Tip Torcon NB Advantage Catheters, Beacon Tip Royal Flush Plus High-Flow Catheters, Beacon Tip Catheters, Shuttle Select Slip-Cath, 4 FR Shuttle System Compatible 2016-01-06 Australia DHTGA
Rappel de One Step HCG Urine Pregnancy Test. An in vitro diagnostic medical device (IVD) 2016-01-08 Australia DHTGA
Rappel de BCS / BCS XP Automated Blood Coagulation Analyser with Dade Innovin .An in vitro diagnostic device (IVD) 2016-01-08 Australia DHTGA
Rappel de Extraction Screw for PFNA Blade 2016-01-07 Australia DHTGA
Rappel de Integra Camino Intracranial Pressure (ICP) Monitor and the Integra Licox PtO2 and Temperature MonitorIntegra Camino Intracranial Pressure (ICP) Monitor 2016-01-08 Australia DHTGA
Rappel de Fujifilm ED-530XT Duodenoscope 2016-04-11 Australia DHTGA
Rappel de Aespire 7900, Aespire View, Aestiva 7900, Aestiva MRI, Aisys, Aisys CS2, Avance, and Avance CS2 Anesthesia devices installed from April 20, 2015 through October 2015. Service kits containing the ventilator Drive Gas Check Valve shipped from April 20, 2015 through October 2015 are also affected 2016-01-12 Australia DHTGA