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Maquet Medical Systems USA Recalls
41 recalls on record · August 8, 2012 to May 22, 2024 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
September 28, 2022Medical DevicesFDA
Maquet Medical Systems USA recalls BEQ-HLS 7050 USA; HLS Set Advanced 7.0 Part No. 70106.9078. A preconnected set used for extracorporeal respirat
Hazard: The firm has expanded the recall for the HLS Set Advanced regarding a potential breach in the sterility barrier that may result in compromised product sterility (prior recall was initiated November 6, 2020).
September 28, 2022Medical DevicesFDA
Maquet Medical Systems USA recalls BEQ-HLS 5050 USA; HLS Set Advanced 5.0 Part No. 70106.9077. A preconnected set used for extracorporeal respirat
Hazard: The firm has expanded the recall for the HLS Set Advanced regarding a potential breach in the sterility barrier that may result in compromised product sterility (prior recall was initiated November 6, 2020).
September 28, 2022Medical DevicesFDA
Maquet Medical Systems USA recalls BEQ-HLS 5050 USA; HLS Set Advanced 5.0 Part No. 70105.2797. A preconnected set used for extracorporeal respirat
Hazard: The firm has expanded the recall for the HLS Set Advanced regarding a potential breach in the sterility barrier that may result in compromised product sterility (prior recall was initiated November 6, 2020).
September 28, 2022Medical DevicesFDA
Maquet Medical Systems USA recalls BEQ-HLS 7050 USA; HLS Set Advanced 7.0 Part No. 70105.2794. A preconnected set used for extracorporeal respirat
Hazard: The firm has expanded the recall for the HLS Set Advanced regarding a potential breach in the sterility barrier that may result in compromised product sterility (prior recall was initiated November 6, 2020).
April 13, 2022Medical DevicesFDA
Maquet Medical Systems USA recalls Cardiohelp-i Transport Guard with Transport Guard (701072525): is a blood oxygenation and carbon dioxide removal syst
Hazard: Potential for a loose cylindrical pin on the Transport Guard that may result in the jamming of the locking mechanism causing the Transport Guard to not open or, if the locking pin is fully disengaged from the assembly, a full disassembly of the Transport Guard may occur, resulting in a delay of support if a product exchange is necessary.
August 4, 2021Medical DevicesFDA
Maquet Medical Systems USA recalls Heater Cooler Unit (HCU 30) The device supplies temperature-controlled water for cardioplegia heat exchangers and for bl
Hazard: There is the potential for contaminated water to enter parts of the Heater-Cooler Unit circuits. There is a potential risk of bacterial contamination including Mycobacteria species.
November 16, 2016Medical DevicesFDA
Maquet Medical Systems USA recalls Accessory Adapter Part number 600525A0 Product Usage: designed for the mounting of MAQUET accessories with the dovet
Hazard: Maquet Inc. is initiating a voluntary field action on the Accessory Adapter part number 600525A0 due to a complaint in which a head rest mounted to the accessory adapter slipped out of the mountain rail.
January 28, 2015Medical DevicesFDA
Maquet Medical Systems USA recalls TEGRIS System manufactured by MAQUET GMBH in Germany The Maquet Tegris OR Integration System is designed to be used as
Hazard: The wrong movement results on the MAGNUS OR table. The button commands on the TEGRIS touchscreen for Lower Leg Up and Upper Leg Down are switched in the software for the integration with the MAGNUS operating table system.
June 18, 2014Medical DevicesFDA
Maquet Medical Systems USA recalls Maquet PowerLED 700. Product Usage; To provide illumination to the surgical area or the patient.
Hazard: Maquet has identified an issue with the Maquet PowerLED 700 (certain serial numbers). One or several plastic fixation tabs can break, which can cause the ambient light module to partially detach.
November 6, 2013Medical DevicesFDA
Maquet Medical Systems USA recalls MAQUET Getinge Group CARDIOHELP Base Unit REF 70104.7999 REF 70104.8012 Manufactured for: MAQUET Cardiopulmonary AG Mad
Hazard: It has come to the attention of MAQUET that in certain rare instances, the CARDIOHELP-i device may display an error message with audible alarm, indicating "battery defective." The alarm will occur-upon start up or when the main power supply is unplugged from the main power source. The human machine interface touch screen of the CARDIOHELP-i device may gradually become black due to the human machine interface (HMI) back light shutting down.
August 8, 2012Medical DevicesFDA
Maquet Medical Systems, Usa recalls Maquet Getinge Group Operating Table System Magnus Carbon-Fibre Table Top Version 1180.16 The carbon-fibre MAGNUS tab
Hazard: As a result of a small number of customer complaints, MAQUET conducted an investigation and identified a potential problem with specific MAGNUS Carbon-Fibre Table Tops manufactured between February 23, 2010 and February 28, 2012 and distributed between November 11, 2010 and April 6, 2012. There is a potential issue with the motor brakes for the longitudinal shift drive, and the tilt drive.