Événements

Nom Date Date de mise en oeuvre Pays Source
Rappel de Freelite Human Kappa Free Kit (use on the Beckman AU (400, 480, 640, 680, 2700, 5400) Series). An in vitro diagnostic medical device (IVD) 2016-10-06 Australia DHTGA
Rappel de Tina-quant Haemoglobin A1c Gen.2 used with COBAS INTEGRA 400 plus analyser, COBAS INTEGRA 800 analyser and cobas c 501/502 modules. An in vitro diagnostic medical device (IVD). 2016-10-10 Australia DHTGA
Rappel de Aptio Automation Modules. An in vitro diagnostic medical device (IVD). 2016-10-10 Australia DHTGA
Rappel de Clearify Visualization System (Laparoscopic Care Kit) 2016-10-05 Australia DHTGA
Rappel de SenoMark UltraCor MRI 14 Gauge Breast Tissue Markers (used for radiographic marking of breast biopsy sites) 2016-10-06 Australia DHTGA
Rappel de Total Hip Software Application 3.1 & 3.1.1 for use with 3.0 Mako system (Robotic surgical navigation system used during total hip arthroplasty) 2016-10-13 Australia DHTGA
Rappel de Fortify, Fortify Assura, Quadra Assura, Unify, Unify Assura and Unify Quadra(Implantable cardiac defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) devices) 2016-10-11 Australia DHTGA
Rappel de iPlan RT Dose / iPlan RT Versions 4.5.3 and 4.5.4, when used in combination with the optional function Dose Planning for Agility Multileaf-Collimator (MLC) 2016-10-07 Australia DHTGA
Rappel de VITROS Immunodiagnostic Products Intact iPTH Reagent Packs & Calibrators (used on VITROS ECi/ECiQ/3600 Immunodiagnostic Systems, & VITROS 5600 Integrated Systems) An in vitro diagnostic medical device (IVD) 2016-10-19 Australia DHTGA
Rappel de Alligator Retrieval Device, Xcelerator Hydrophilic Guidewire and Marathon Microcatheter (with Stylet) 2016-10-07 Australia DHTGA
Rappel de ALBAclone Advanced Partial RhD Typing Kit. An in vitro diagnostic medical device (IVD). 2016-10-13 Australia DHTGA
Rappel de Fujifilm Synapse PACS software version 4.0, 4.1, 4.2, 4.3 (a picture archiving and communication system) 2017-11-20 Australia DHTGA
Rappel de Lumenis FemTouch Delivery System (used with AcuPulse laser system and AcuScan120 microscanner for gynecological treatments) 2016-11-07 Australia DHTGA
Rappel de Blood Pressure Monitoring Kits with Transpac IV Transducers 2016-10-19 Australia DHTGA
Rappel de Human sTfR Quantikine IVD ELISA Kit (used as indicator of iron status). An in vitro diagnostic medical device (IVD). 2016-10-20 Australia DHTGA
Rappel de Vitamin D Total 100 Tests and Vitamin D Total 500 Tests (Used with ADVIA Centaur / ADVIA Centaur XP / ADVIA Centaur XPT Systems) 2016-10-17 Australia DHTGA
Rappel de TBS iNsight v. 3.0.1 (software installed on bone densitometers for estimating fracture risk) 2016-10-21 Australia DHTGA
Rappel de ARCHITECT Lactic Acid. An in vitro diagnostic medical device (IVD) 2016-10-24 Australia DHTGA
Rappel de MAGNETOM Combi Dockable Neurosurgery Table 2016-10-14 Australia DHTGA
Rappel de RaySearch RayStation 5 (Radiation therapy treatment planning system) 2016-10-17 Australia DHTGA
Rappel de Bard Inlay Optima Ureteral Stents InLay Optima Multi-length Ureteral Stent with NiCoreNitinol/Nitinol Guidewire, InLay Optima Multi-length Ureteral Stent with HydroGlide Guidewire, InLay Optima Multi-length Ureteral Stent without Guidewire 2016-10-18 Australia DHTGA
Rappel de SynReam Reaming Rod 2.5mm, L 650mm, sterile(re-usable surgical instrument supplied as part of the SynReam Reaming medullary reaming system) 2016-10-20 Australia DHTGA
Rappel de Chemistry Calibrator used with ADVIA Chemistry Systems Direct Bilirubin Assay (DBIL_2). An in vitro diagnostic medical device (IVD). 2016-10-18 Australia DHTGA
Rappel de VITROS Chemistry Products Calibrator Kit 25 (used on VITROS 4600/5600 Systems and with VITROS Chemistry Products dHDL Slides). An in vitro diagnostic medical device (IVD). 2016-10-18 Australia DHTGA
Rappel de LABType DNA Typing Tests (for transplant compatibility analysis). An in vitro diagnostic medical device (IVD). 2017-05-17 Australia DHTGA