Devices

Name Classification Manufacturer Risk Class Country Source
CP5 control panels and HLM bubble sensors and EP packs manufactured prior to 10 February, 2017 Cardiovascular Devices LivaNova Australia Pty Ltd Australia
Sorin Group perfusion system – Heater Cooler 1T devices LivaNova Australia Pty Ltd Australia
Sorin Group perfusion system – Heater Cooler 3T devices Cardiovascular Devices LivaNova Australia Pty Ltd Australia
Platinium Implantable Cardiac Defibrillators (ICDs) and Cardiac Resynchronisation Therapy Defibrillators (CRT-Ds) LivaNova Australia Pty Ltd Australia
Ovatio, Paradym, Paradym RF and Intensia Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronisation Therapy Defibrillators (CRT-Ds) LivaNova Australia Pty Ltd Australia
FlexTherm Heater Cooler Device LivaNova Australia Pty Ltd Australia
Perceval Sutureless Aortic Heart Valves (bioprosthetic heart valve) Cardiovascular Devices LivaNova Australia Pty Ltd Australia
Synthesis, Avant & Primo2x Families Adult Oxygenator Mounting Brackets (used with Sorin 3T Heater-Cooler devices) LivaNova Australia Pty Ltd Australia
CONSERVE Shell, DYNASTY Metal Liner, RIM-LOCK Metal Liner, LINEAGE Metal Liner (components used for Metal on Metal (MoM) Total Hip Arthroplasty) MicroPort Orthopedics Pty Ltd Australia
Tecotherm Neo (a heating/cooling system for use with infants) Innervate Pty Ltd Australia
LQT6283LB In-line leucoreduction system for red cell concentrates with LCRD2 Leucoflex soft filter MacoPharma Australia Pty Ltd Australia
Macopharma blood bags MacoPharma Australia Pty Ltd Australia
Medela breastpumps detachable wall plug component of AC Power Adaptor Supplied with:Medela Swing, Medela Swing Maxi, Medela Swing Premium, Medela Swing Essentials, Medela Freestyle, Stand-alone AC Power Adaptor (for use with Swing Maxi and Freestyle), Affected AC Power Adaptors were supplied between 2009 and 2016 Medela Australia Pty Ltd Australia
Sorg Jump Alpha, Jump Beta and Vector WheelchairsWheelchairs with back tubes made of section tubes with groove Manufactured between 01/2008 - 09/2015 Motum Pty Ltd Australia
Panthera S3 Wheelchair Motum Pty Ltd Australia
Debriflo Ultrasonic Wound Irrigation Hand-piece Debriflo Pty Ltd Australia
Accu-Chek Connect diabetes management app – Bolus Advisor function Roche Diabetes Care Australia Pty Ltd Australia
Accu-Chek Connect diabetes management app Roche Diabetes Care Australia Pty Ltd Australia
Accu-Chek Connect Diabetes Management App for iPhone (iOS) v1.2.0(.5) (used in conjunction with Roche Accu-Chek Avica Connect and Accu-Chek Guide Blood Glucose Meters). General Hospital and Personal Use Devices Roche Diabetes Care Australia Pty Ltd Australia
Eyesaline Eyewash Solution, 32oz, for use with Eyesaline Wall Station (for emergency eye rinsing) Honeywell Safety Products Australia
FerriScan (software for determining liver iron concentration from MRI images) Resonance Health Analysis Services Pty Ltd Australia
Sterile Single Use Minor Surgery Bipolar Cable, IEC-BC (Used for connecting the bipolar handpieces to the RF generator for electrosurgical procedures) Cynosure Pty Ltd Australia
Quantum Blue Calprotectin Assay and Quantum Blue Calprotectin High Range Taylor Bio-Medical Pty Ltd Australia
Xpert HIV-l Viral LoadAn in vitro medical device Cepheid Holdings Pty Ltd Australia
Xpert EV Assay. An in vitro diagnostic medical device (IVD) Cepheid Holdings Pty Ltd Australia