Getinge Usa Sales Inc recalls
26 recalls in our records from 2018 to 2025: 26 FDA medical devices.
Recalls with full detail pages
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Getinge Usa Sales Inc medical device recall: Vaporizer Sevoflurane
Sevoflurane used with the vaporizer may degrade to hydrogen fluoride, which could present a risk to patients or health care providers through inhalation and/or skin…
Earlier and other recalls
These link to the official agency notice.
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Getinge Usa Sales Inc medical device recall: MEERA CL mobile operating table - Designed for the placement and… Official notice ↗
Error code "50037" occurs on the IR-Hand Control when a MEERA-table is controlled, and the table stops the movement. This error may occur sporadically when the…
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Getinge Usa Sales Inc medical device recall: ALPHAMAXX Mobile Operating Table Official notice ↗
The recall is prompted by a defective charger unit (0970.2873) for models 1133.22B4, 1133.22B5, and 1133.22F5 of the ALPHAMAXX mobile operating table. This issue poses a…
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Getinge Usa Sales Inc medical device recall: Vaporizer Sevoflurane Maquet Filling Official notice ↗
Sevoflurane used with the vaporizer may degrade to hydrogen fluoride, which could present a risk to patients or health care providers through inhalation and/or skin…
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Getinge Usa Sales Inc medical device recall: Flow-i C20 Anesthesia System Official notice ↗
Potential cybersecurity vulnerability that could lead to a Denial of Service (DoS) attack, tampering, or remote code execution via remote login to the Flow Anesthesia…
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Getinge Usa Sales Inc medical device recall: Maquet PowerLEDII OR Light System Official notice ↗
A potential for a light system to fall in the operating room.
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Getinge Usa Sales Inc medical device recall: Meera Mobile Operating Table-to support and position the patient… Official notice ↗
Under certain conditions, an issue might prevent the device from performing as intended. A specific sequence of commands on the control unit activates the traction drive…
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Getinge Usa Sales Inc medical device recall: Getinge Flow-i Anesthesia Systems Flow-i C20 Official notice ↗
Due to a software bug, under certain conditions, pressure cannot be built up resulting in no ventilation. If gas delivery is stopped, a sustained decrease in delivered…
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Getinge Usa Sales Inc medical device recall: Flow-c Anesthesia System Official notice ↗
The power backup battery, under certain conditions, may exhibit reduced battery run-time while in use, and there is a potential that the battery may fail to provide the…
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Getinge Usa Sales Inc medical device recall: Extension Tabletop for Operating Table System 1140 Official notice ↗
The back rest may unintentionally drop suddenly, resulting in adverse health consequences if a patient were to fall on the floor head first and at a steep angle.
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Getinge Usa Sales Inc medical device recall: Servo-air Ventilator System-The Servo-air Ventilator System is:… Official notice ↗
Device does not meet regulatory requirements of stability while stationary, which requires mechanical equipment, other than fixed mechanical equipment, that is intended…
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Getinge Usa Sales Inc medical device recall: Maquet Critical Care AB/Getinge Servo-u Ventilator System Official notice ↗
Ventilators may generate a combination of alarms which may result in loss of communication, technical alarms being triggered, and loss of ventilation. If the device…
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Getinge Usa Sales Inc medical device recall: VOLISTA StandOP Surgical Light Official notice ↗
Paint particles may detach and fall in the operating field. In the worst case scenario, infection, organ irritation, hypersensitivity reaction, and tissue granuloma may…
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Getinge Usa Sales Inc medical device recall: Flow-c Anesthesia System : intended for use in administering… Official notice ↗
Potential for crack to form on the on/off switch of the suction unit, which may result in an unreasonable risk of harm to the patient. In the worst case, the switch can…
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Getinge Usa Sales Inc medical device recall: Getinge CM320-2 CHAMBER WU Series Washer Disinfector- For Use as a… Official notice ↗
Verification of installation not documented or may be incomplete, could result in harm to the user such as skin burns, smoke inhalation, electric shock, or a crush or…
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Getinge Usa Sales Inc medical device recall: Getinge 9100-Series Washer Disinfector models: 9120E Official notice ↗
Inadequate documentation verifying whether device installation has been executed in accordance with the manufacturer's requirements. This can lead to installation…
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Getinge Usa Sales Inc medical device recall: Vaporizer Sevoflurane Maquet Filling Official notice ↗
A potential chemical degradation of Sevoflurane by Lewis acids (metal oxides and metal halides) has been discovered that may result in inhalation and/or skin exposure of…
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Getinge US Sales LLC medical device recall: Maquet Cardiopulmonary GmbH / Getinge Quadrox-iD Pediatric Diffusion… Official notice ↗
Sterile barrier system may be compromised
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Getinge US Sales LLC medical device recall: The HEMASHIELD PLATINUM Woven Double Velour Vascular Graft is a woven… Official notice ↗
Based on an internal incident report, Getinge/Intervascular SAS has identified that the one (1) HEMASHIELD GOLD Knitted Microvel Double Velour Vascular Bifurcated Graft…
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Getinge US Sales LLC medical device recall: Getinge MCC Flow i Disposable CO2 absorber Official notice ↗
Reversed expiration and manufacturing date on the label
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Getinge US Sales LLC medical device recall: PulsioFlex Monitoring System Official notice ↗
The monitor displays an error message . The error message states "internal error restart or service".
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Getinge US Sales LLC medical device recall: Maquet Servo-I Ventilator System -EDI CATHETER PHT Free 6Fr/49cm… Official notice ↗
Edi Catheter labeled with wrong expiry date on single pack EDI catheter boxes
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Getinge US Sales LLC medical device recall: Maquet XS Flat Screen Monitor Holder Official notice ↗
The affected flat screen monitor holders might not be compliant with grounding requirements. As a consequence, there is a risk of mild to severe/fatal electric shock…
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Getinge US Sales LLC medical device recall: ALM XTEN Surgical Light intended to provide visible illumination for… Official notice ↗
Getinge has received complaints concerning the X TEN Surgical Lights whose spring arms have broken, causing light heads to separate from the assembly. The issue relates…
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Getinge US Sales LLC medical device recall: VOLISTA StandOP Surgical Light Official notice ↗
The manufacturer received complaints indicating that the device's central handle holder detaches easily from the handle holder ring on the light head during clinical…
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Getinge US Sales LLC medical device recall: HEMASHIELD Knitted Double Velour Cardiovascular Fabric Official notice ↗
A probable mislabeling of the product: a different-sized product is referenced on the product packaging label (i.e. 2.5 cm (width) x 7.6 cm (length)) while the actual…
Firm names are matched across agencies by name only. Different companies with similar names may be grouped together; check each official notice.