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Crédits
Manufacturers
LivaNova Australia Pty Ltd
Société-mère du fabricant (2017)
LivaNova PLC
Source
DHTGA
9 Events
Rappel de Synthesis, Avant & Primo2x Families Adult Oxygenator Mounting Brackets (used with Sorin 3T Heater-Cooler devices)
Rappel de Perceval Sutureless Aortic Heart Valves (bioprosthetic heart valve)
Rappel de FlexTherm Heater Cooler Device
Rappel de Ovatio, Paradym, Paradym RF and Intensia Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronisation Therapy Defibrillators (CRT-Ds)
Rappel de Platinium Implantable Cardiac Defibrillators (ICDs) and Cardiac Resynchronisation Therapy Defibrillators (CRT-Ds)
Rappel de Sorin Group perfusion system – Heater Cooler 3T devices
Rappel de Sorin Group perfusion system – Heater Cooler 1T devices
Rappel de CP5 control panels and HLM bubble sensors and EP packs manufactured prior to 10 February, 2017
Rappel de Platinium Implantable Cardiac Defibrillator (ICD) and Resynchronisation Therapy Defibrillator (CRT-D)
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9 dispositifs dans la base de données
Synthesis, Avant & Primo2x Families Adult Oxygenator Mounting Brackets (used with Sorin 3T Heater...
Modèle / numéro de série
Synthesis, Avant & Primo2x Families Adult Oxygenator Mounting Brackets (used with Sorin 3T Heater-Cooler devices)D632 Adult Open System Bracket Catalogue Number: 05046Adult Oxy module Avant Bracket Catalogue Number: 050128Synthesis “C” BracketCatalogue Number: 050350Synergy Bracket Catalogue Number: 050131D626 Avant Holder Catalogue Number: 05040D630 Avant Holder Catalogue Number: 05041Synthesis Oxygenator Holder Catalogue Number: 050127ARTG # 194514
Perceval Sutureless Aortic Heart Valves (bioprosthetic heart valve)
Modèle / numéro de série
Perceval Sutureless Aortic Heart Valves (bioprosthetic heart valve)Perceval Sutureless Heart Valve size SItem Number: ICV1208Reference: PVS21Perceval Sutureless Heart Valve size MItem Number: ICV1209Reference: PVS23Perceval Sutureless Heart Valve size LItem Number: ICV1210Reference: PVS25Perceval Sutureless Heart Valve size XLItem Number: ICV1211Reference: PVS27ARTG Number: 232485
Classification du dispositif
Cardiovascular Devices
FlexTherm Heater Cooler Device
Modèle / numéro de série
FlexTherm Heater Cooler DeviceProduct Code: 16-70-00Affected Serial Number in Australia: 16E01091ARTG Number: 194514
Ovatio, Paradym, Paradym RF and Intensia Implantable Cardioverter Defibrillators (ICDs) and Cardi...
Modèle / numéro de série
Ovatio, Paradym, Paradym RF and Intensia Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronisation Therapy Defibrillators (CRT-Ds)Ovatio - CRT 6750, DR 6550, VR 6250Previous ARTG #: 132650, 132586, 132649 Paradym - VR 8250, DR 8550, CRT-D 8750ARTG #: 170105, 170104, 163470,Paradym RF - VR 9250, DR 9550, CRT-D 975, SonR 9770 ARTG #: 197571, 197572, 197573, 197574Intensia - VR 124, DR 154, CRT-D 174, SonR CRT-D 184ARTG #: 230583, 230582, 230580, 230581
Platinium Implantable Cardiac Defibrillators (ICDs) and Cardiac Resynchronisation Therapy Defibri...
Modèle / numéro de série
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
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