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Manufacturers
LivaNova Australia Pty Ltd
Manufacturer Parent Company (2017)
LivaNova PLC
Source
DHTGA
9 Events
Recall of Platinium Implantable Cardiac Defibrillator (ICD) and Resynchronisation Therapy Defibrillator (CRT-D)
Recall of CP5 control panels and HLM bubble sensors and EP packs manufactured prior to 10 February, 2017
Recall of Sorin Group perfusion system – Heater Cooler 1T devices
Recall of Sorin Group perfusion system – Heater Cooler 3T devices
Recall of Platinium Implantable Cardiac Defibrillators (ICDs) and Cardiac Resynchronisation Therapy Defibrillators (CRT-Ds)
Recall of Ovatio, Paradym, Paradym RF and Intensia Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronisation Therapy Defibrillators (CRT-Ds)
Recall of FlexTherm Heater Cooler Device
Recall of Perceval Sutureless Aortic Heart Valves (bioprosthetic heart valve)
Recall of Synthesis, Avant & Primo2x Families Adult Oxygenator Mounting Brackets (used with Sorin 3T Heater-Cooler devices)
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9 devices in the database
Platinium Implantable Cardiac Defibrillator (ICD) and Resynchronisation Therapy Defibrillator (CR...
Model / Serial
Platinium Implantable Cardiac Defibrillator (ICD) and Resynchronisation Therapy Defibrillator (CRT-D)PLATINIUM VR 1210ARTG No: 282817PLATINIUM VR 1240ARTG No: 282816PLATINIUM DR 1510ARTG No: 282818PLATINIUM DR 1540ARTG No: 282819PLATINIUM CRT-D 1711ARTG No: 282820PLATINIUM CRT-D 1741ARTG No: 282821PLATINIUM SONR CRT-D 1811ARTG No: 282822PLATINIUM SONR CRT-D 1841ARTG No: 282823
CP5 control panels and HLM bubble sensors and EP packs manufactured prior to 10 February, 2017
Model / Serial
CP5 control panels and HLM bubble sensors and EP packs manufactured prior to 10 February, 2017ARTG Number: 94208 (LivaNova Australia Pty LtdCirculatory assist unit, pump, centrifugal)
Product Classification
Cardiovascular Devices
Sorin Group perfusion system – Heater Cooler 1T devices
Model / Serial
Sorin Group perfusion system – Heater Cooler 1T devices All Serial Numbers ARTG Number 194514
Sorin Group perfusion system – Heater Cooler 3T devices
Model / Serial
Sorin Group perfusion system – Heater Cooler 3T devicesAll Serial NumbersARTG Number: 194514
Product Classification
Cardiovascular Devices
Platinium Implantable Cardiac Defibrillators (ICDs) and Cardiac Resynchronisation Therapy Defibri...
Model / Serial
Platinium Implantable Cardiac Defibrillators (ICDs) and Cardiac Resynchronisation Therapy Defibrillators (CRT-Ds)Platinium VR 1210Platinium VR 1240Platinium DR 1510Platinium DR 1540Platinium CRT-D 1711Platinium CRT-D 1741Platinium SONR CRT-D 1811Platinium SONR CRT-D 1841ARTG Numbers: 282817, 282816, 282818, 282819, 282820, 282821, 282822 and 282823
4 more
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