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Manufacturers
Maquet Australia Pty Ltd
Manufacturer Parent Company (2017)
Getinge AB
Source
DHTGA
37 Events
Recall of Heater Unit HU 35
Recall of Maquet Heater-Cooler Unit HCU 40
Recall of SoKINOX NO (Nitric Oxide) Delivery and Monitoring System
Recall of Maquet/Datascope Intra-Aortic Balloon Pump (IABP)
Recall of Atrium Thoracic Catheters, Sizes 8Fr & 10Fr
Recall of Li-Ion Battery used with the Cardiosave Hybrid/Rescue Intra-aortic Balloon Pump (IABP)
Recall of HICO - Variotherm 550 Hypothermia/Hyperthermia Unit
Recall of Atrium Chest DrainsOcean Drains
Recall of MAQUET HLS and PLS Sets with BIOLINE Coating (extracorporeal support sets)BE-HLS 5050 HLS Set Advanced 5.0
Recall of Atrium Trocar Catheters, Sizes 8Fr to 32FrProduct Code Numbers: 8408, 8410, 8412, 8416, 8420, 8424, 8428, 8432
Recall of MAQUET operating table accessories with Accessory Adaptor 600525A0 Manufactured from 2002 onwards
Recall of Maquet Operating Table with Fixture 1002.65AO Manufactured in the period between 2009 and 2013
Recall of SERVO-i/s ventilator systems with software version 8.00.00
Recall of STATLOCK IAB Stabilisation Device (offers needle-free securement for intra-aortic balloon (IAB) catheters)
Recall of Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP) Distributed from 6 March 2012 to 31 December 2015
Recall of 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)
Recall of 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
Recall of MAGNUS Hybrid OR table column 1180.01B2
Recall of CARDIOHELP Perfusion System, Software versions prior to 3.4.6.0
Recall of CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP)
Recall of PowerLED, Hied, Xten, Standop Volista, Hanaulux 3000 range - SA Ceiling Suspension
Recall of Maquet demonstration unit fiber-optic Intra-Aortic Balloon Catheter
Recall of Tegris OR Table Control (Operating room device management system)
Recall of Datascope System 98/98XT, CS100/CS100i and CS300 Intra-Aortic Balloon Pumps (IABP)
Recall of H LED and PowerLED Ambient Light Modules (Surgical light)
Recall of Edi Catheter (nasogastric feeding tube)
Recall of Weinmann Medumat Transport Ventilator
Recall of CARDIOHELP-I (Heart-lung bypass system)Serial numbers affected: 90140472, 901404544, 90410553ARTG Number: 179104
Recall of Secondary 19" Touchscreen - TEGRIS System (Operating room device management system)
Recall of Maquet Heater Unit
Recall of YUNO Table Extension device
Recall of CARDIOHELP-1, software version 3.3.0 (Heart-lung bypass system)
Recall of 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
Recall of MAQUET Heart Lung Machine - HL30 (Heart-lung bypass system)
Recall of ELS Cannulae (Part of intravenous catheterisation kit)
Recall of YUNO Extension Device (used to support and stabilise the patient's body during a surgical procedure)
Recall of HLS Cannulae (Used for the cannulation of suitable vessels during extra corporeal circulation as inflow or outflow cannula)
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37 devices in the database
Heater Unit HU 35
Model / Serial
Heater Unit HU 35All Models and Serial NumbersARTG Number: 144010
Maquet Heater-Cooler Unit HCU 40
Model / Serial
Maquet Heater-Cooler Unit HCU 40All Serial Numbers below 90441000ARTG Number 144010
SoKINOX NO (Nitric Oxide) Delivery and Monitoring System
Model / Serial
SoKINOX NO (Nitric Oxide) Delivery and Monitoring SystemDevice Number: 66 94 550ARTG Number: 273803
Maquet/Datascope Intra-Aortic Balloon Pump (IABP)
Model / Serial
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
Product Classification
Cardiovascular Devices
Atrium Thoracic Catheters, Sizes 8Fr & 10Fr
Model / Serial
Atrium Thoracic Catheters, Sizes 8Fr & 10FrProduct Code Numbers: 8008, 8010All Lot NumbersARTG Number: 97358
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Maquet Australia Pty Ltd
Manufacturer Parent Company (2017)
Getinge AB
Manufacturers representative
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