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Manufacturers
Maquet Australia Pty Ltd
제조사 모회사 (2017)
Getinge AB
Source
DHTGA
37 Events
Heater Unit HU 35 의 리콜
Maquet Heater-Cooler Unit HCU 40 의 리콜
SoKINOX NO (Nitric Oxide) Delivery and Monitoring System 의 리콜
Maquet/Datascope Intra-Aortic Balloon Pump (IABP) 의 리콜
Atrium Thoracic Catheters, Sizes 8Fr & 10Fr 의 리콜
Li-Ion Battery used with the Cardiosave Hybrid/Rescue Intra-aortic Balloon Pump (IABP) 의 리콜
HICO - Variotherm 550 Hypothermia/Hyperthermia Unit 의 리콜
Atrium Chest DrainsOcean Drains 의 리콜
MAQUET HLS and PLS Sets with BIOLINE Coating (extracorporeal support sets)BE-HLS 5050 HLS Set Advanced 5.0 의 리콜
Atrium Trocar Catheters, Sizes 8Fr to 32FrProduct Code Numbers: 8408, 8410, 8412, 8416, 8420, 8424, 8428, 8432 의 리콜
MAQUET operating table accessories with Accessory Adaptor 600525A0 Manufactured from 2002 onwards 의 리콜
Maquet Operating Table with Fixture 1002.65AO Manufactured in the period between 2009 and 2013 의 리콜
SERVO-i/s ventilator systems with software version 8.00.00 의 리콜
STATLOCK IAB Stabilisation Device (offers needle-free securement for intra-aortic balloon (IAB) catheters) 의 리콜
Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP) Distributed from 6 March 2012 to 31 December 2015 의 리콜
CARDIOSAVE Hybrid and Rescue Intra-aortic Balloon Pumps (IABP) (Used to inflate and deflate intra-aortic balloons for temporary support of the left ventricle via the principle of counter-pulsation) 의 리콜
MAQUET HCU 30 Base UnitHeater-Cooler Unit 30 with Serial Number < 93101480HCU 30 Base Unit 100 -120 V, article number 704629 / 70103.4371 HCU 30 base unit 200 -240 V, article number 704631 / 70103.4642 HCU 30 base unit Canadian/US, article number 705501 / 70103.4653 의 리콜
MAGNUS Hybrid OR table column 1180.01B2 의 리콜
CARDIOHELP Perfusion System, Software versions prior to 3.4.6.0 의 리콜
CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP) 의 리콜
PowerLED, Hied, Xten, Standop Volista, Hanaulux 3000 range - SA Ceiling Suspension 의 리콜
Maquet demonstration unit fiber-optic Intra-Aortic Balloon Catheter 의 리콜
Tegris OR Table Control (Operating room device management system) 의 리콜
Datascope System 98/98XT, CS100/CS100i and CS300 Intra-Aortic Balloon Pumps (IABP) 의 리콜
H LED and PowerLED Ambient Light Modules (Surgical light) 의 리콜
Edi Catheter (nasogastric feeding tube) 의 리콜
Weinmann Medumat Transport Ventilator 의 리콜
CARDIOHELP-I (Heart-lung bypass system)Serial numbers affected: 90140472, 901404544, 90410553ARTG Number: 179104 의 리콜
Secondary 19" Touchscreen - TEGRIS System (Operating room device management system) 의 리콜
Maquet Heater Unit 의 리콜
YUNO Table Extension device 의 리콜
CARDIOHELP-1, software version 3.3.0 (Heart-lung bypass system) 의 리콜
MAQUET QUADROX-i Oxygenators (excluding HLS) and Blood Outlet Connectors-QUADROX-i(D) adult, small adult, paediatric and neonatal with Softline and Bioline Coating-PLS-i gas exchanger in PLS sets -PLS gas exchanger in HIT -PLS sets-Quadrox-iR with Softline coating 의 리콜
MAQUET Heart Lung Machine - HL30 (Heart-lung bypass system) 의 리콜
ELS Cannulae (Part of intravenous catheterisation kit) 의 리콜
YUNO Extension Device (used to support and stabilise the patient's body during a surgical procedure) 의 리콜
HLS Cannulae (Used for the cannulation of suitable vessels during extra corporeal circulation as inflow or outflow cannula) 의 리콜
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데이터베이스에서 발견된 의료기기 1건 데이터베이스에서 발견된 의료기기 37 건
Heater Unit HU 35
모델명 / 제조번호(시리얼번호)
Heater Unit HU 35All Models and Serial NumbersARTG Number: 144010
Maquet Heater-Cooler Unit HCU 40
모델명 / 제조번호(시리얼번호)
Maquet Heater-Cooler Unit HCU 40All Serial Numbers below 90441000ARTG Number 144010
SoKINOX NO (Nitric Oxide) Delivery and Monitoring System
모델명 / 제조번호(시리얼번호)
SoKINOX NO (Nitric Oxide) Delivery and Monitoring SystemDevice Number: 66 94 550ARTG Number: 273803
Maquet/Datascope Intra-Aortic Balloon Pump (IABP)
모델명 / 제조번호(시리얼번호)
Maquet/Datascope Intra-Aortic Balloon Pump (IABP)CS100i IABPPart Numbers: 0998-UC-0446HXX, 0998-UC-0479HXXCS100 IABPPart Numbers: 0998-00-3013-XX, 0998-UC-3013-XXCS300 IABPPart Numbers: 0998-00-3023-XX, 0998-UC-3023-XXDistributed between 24 March 2003 through to 11 December 2013ARTG Number: 118266
의료기기 분류등급
Cardiovascular Devices
Atrium Thoracic Catheters, Sizes 8Fr & 10Fr
모델명 / 제조번호(시리얼번호)
Atrium Thoracic Catheters, Sizes 8Fr & 10FrProduct Code Numbers: 8008, 8010All Lot NumbersARTG Number: 97358
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여기
Maquet Australia Pty Ltd
제조사 모회사 (2017)
Getinge AB
제조사 대표
مستودع ادوية الاتحاد ش.م.ل.
Source
RLMPH
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