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Manufacturers
LivaNova Australia Pty Ltd
제조사 모회사 (2017)
LivaNova PLC
Source
DHTGA
9 Events
Synthesis, Avant & Primo2x Families Adult Oxygenator Mounting Brackets (used with Sorin 3T Heater-Cooler devices) 의 리콜
Perceval Sutureless Aortic Heart Valves (bioprosthetic heart valve) 의 리콜
FlexTherm Heater Cooler Device 의 리콜
Ovatio, Paradym, Paradym RF and Intensia Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronisation Therapy Defibrillators (CRT-Ds) 의 리콜
Platinium Implantable Cardiac Defibrillators (ICDs) and Cardiac Resynchronisation Therapy Defibrillators (CRT-Ds) 의 리콜
Sorin Group perfusion system – Heater Cooler 3T devices 의 리콜
Sorin Group perfusion system – Heater Cooler 1T devices 의 리콜
CP5 control panels and HLM bubble sensors and EP packs manufactured prior to 10 February, 2017 의 리콜
Platinium Implantable Cardiac Defibrillator (ICD) and Resynchronisation Therapy Defibrillator (CRT-D) 의 리콜
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데이터베이스에서 발견된 의료기기 1건 데이터베이스에서 발견된 의료기기 9 건
Synthesis, Avant & Primo2x Families Adult Oxygenator Mounting Brackets (used with Sorin 3T Heater...
모델명 / 제조번호(시리얼번호)
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)
모델명 / 제조번호(시리얼번호)
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
의료기기 분류등급
Cardiovascular Devices
FlexTherm Heater Cooler Device
모델명 / 제조번호(시리얼번호)
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...
모델명 / 제조번호(시리얼번호)
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...
모델명 / 제조번호(시리얼번호)
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
하나 더 4 건 더
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