Événements

Nom Date Date de mise en oeuvre Pays Source
Rappel de Cortex Screw Ø 4.5mm, self-tapping, length 20mm, Pure Titanium 2016-05-03 Australia DHTGA
Rappel de Xhibit Central Station (patient monitoring system) 2016-05-03 Australia DHTGA
Rappel de ADVIA Centaur XPT Systems. An in vitro diagnostic medical device (IVD) 2016-05-03 Australia DHTGA
Rappel de Brilliance CT 64-Channel with Essence Technology, Ingenuity Core, Ingenuity Core128 and Ingenuity CT, software versions v4.1.3, v4.1.4 and 4.1.5 (used for diagnostic computed tomography scanning) 2016-05-12 Australia DHTGA
Rappel de Multiple Assay for Enzymatic Creatinine, Cholesterol, Triglyceride, Uric Acid, Lactate, Lipase. An in vitro diagnostic medical device (IVD) 2016-05-11 Australia DHTGA
Rappel de SMR Glenosphere Impactor 2016-05-06 Australia DHTGA
Rappel de HeartWare HVAD system 2016-05-11 Australia DHTGA
Rappel de Brilliance iCT and iCT SP, with software versions v4.1.3 and v4.1.5 2016-05-12 Australia DHTGA
Rappel de LIFECODES HLA-C eRES SSO Typing Kit. An in vitro diagnostic medical device (IVD) 2016-05-12 Australia DHTGA
Rappel de MobileDiagnost wDR 2, all software versions affected (diagnostic x-ray system) 2016-05-06 Australia DHTGA
Rappel de Ingenuity Core128 CT System 2016-05-06 Australia DHTGA
Rappel de EliA IgG Conjugate. An in vitro diagnostic medical device (IVD). 2016-05-27 Australia DHTGA
Rappel de Volcano S5, S5i, CORE, CORE Mobile Systems with software versions v3.2x, v3.3, v3.4.1 (used to diagnose anatomical defects of the heart or problems associated with myocardial infarction) 2016-05-10 Australia DHTGA
Rappel de TnI-Ultra (Troponin) Assay, 100 and 500 tests (used in the determination of cardiac troponin). An in vitro diagnostic medical device (IVD) Systems affected: ADVIA Centaur, ADVIA Centaur XP, ADVIA Centaur XPT, ADVIA Centaur CP 2016-05-12 Australia DHTGA
Rappel de Threader Monorail and Threader Over the Wire Micro-Dilatation Catheters (used during angioplasty procedures) 2016-05-09 Australia DHTGA
Rappel de Centurion FMS (Fluidics Management System) Pack (used to control irrigation and aspiration in the eye during cataract surgery) 2016-05-09 Australia DHTGA
Rappel de MX 16-slice CT x-ray systems with software version v1.1.4.21426. 2016-05-12 Australia DHTGA
Rappel de AVOXimeter System (a whole blood oximeter used during heart catheterisation procedures) 2016-05-12 Australia DHTGA
Rappel de RAPID Hp StAR Kit (used in the detection of H. pylori). An in vitro diagnostic medical device (IVD) 2016-05-10 Australia DHTGA
Rappel de Alphadent Ceka-Preciline Dental Devices - Ceka, Revax. Preci-Ball, Preci-Horix. Preci-bar and Preci-Clip 2016-06-15 Australia DHTGA
Rappel de Cordis PRECISE PRO RX Nitinol Stent System (Carotid) 2016-05-11 Australia DHTGA
Rappel de TRUEresult Blood Glucose Test Strip (10 counts) (used with the TRUEresult Blood Glucose Monitoring System). An in vitro diagnostic medical device (IVD) 2016-05-18 Australia DHTGA
Rappel de Hexapod iGUIDE 2.1, iGUIDE 2.2 2016-05-19 Australia DHTGA
Rappel de Brilliance CT and Ingenuity CT systems with software version v4.1.3 and v4.1.4 2016-05-13 Australia DHTGA
Rappel de DigitalDiagnost Affected Products: DigitalDiagnost Release 4.0.4, 4.1.2, 4.1.3 2016-05-13 Australia DHTGA