Getinge Usa Sales recalls
17 official recalls and safety alerts involving Getinge Usa Sales since 2022-01, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Getinge Usa Sales or the relevant agency.
- 2025-02-19
USGetinge Usa Sales Inc recalls Vaporizer Sevoflurane, Quik-Fil. Model Number: 6682285. Device is a component of Flow-i C20, Flow-i C30, Flow-i C40, Flow-c, Flow-e. For…
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 exposure. Potential harms include irritation of…
FDA · DeviceGetinge Usa Sales IncDomestic distribution to Kentucky and Connecticut.Official notice →- 2024-11-20
- US
Getinge Usa Sales Inc recalls MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during and after surgical…
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 MEERA-table is controlled via an IR-Hand Control and may…
FDA · DeviceGetinge Usa Sales IncWorldwide distribution - US Nationwide and the countries of Australia,…Official notice → - 2024-07-17
- US
Getinge Usa Sales Inc recalls ALPHAMAXX Mobile Operating Table, Model Number/Part Number: 113322B4
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 risk of inadequate charging and operational…
FDA · DeviceGetinge Usa Sales IncDomestic: KY, NC, NY, VA. International: Australia, Bulgaria, Croatia, Czech…Official notice → - 2024-06-12
- US
Getinge Usa Sales Inc recalls Vaporizer Sevoflurane Maquet Filling, Product code/REF number (6682282), Component of: Flow-i C20, Flow-i C30,Flow-i C40, Flow-c, Flow-e.
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 exposure. Potential harms include irritation of…
FDA · DeviceGetinge Usa Sales IncDomestic: CA, CO, IN, MO, OR, VA, WA. International: Aruba, Australia,…Official notice → - 2024-02-14
- US
Getinge Usa Sales Inc recalls Flow-c Anesthesia System, model 6887700
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 System, any of which could lead to a hazardous…
FDA · DeviceGetinge Usa Sales IncWorldwide - US Nationwide distribution in the states of AL, AR, AZ, CA, CO,…Official notice → - 2024-01-24
- US
Getinge Usa Sales Inc recalls Maquet PowerLED/HLED and PowerLED300 OR Light Systems, Model Numbers and Catalog Numbers EPS MB1 - ARDINT059002A, EPS MB1 - ARDINT059002C,…
A potential for a light system to fall in the operating room.
- 2023-10-11
- US
Getinge Usa Sales Inc recalls Meera Mobile Operating Table-to support and position the patient immediately before, during and after surgical interventions as well as…
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 and triggers an unintended driving (autodrive)…
- 2023-02-01
- US
Getinge Usa Sales Inc recalls Getinge Flow-e Anesthesia System, Part No. 6887900
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 O2 concentration may lead to hypoventilation and…
FDA · DeviceGetinge Usa Sales IncUS nationwide and Worldwide Distribution: Domestic distribution to AL, AR, AZ,…Official notice → - 2022-12-14
- US
Getinge Usa Sales Inc recalls Flow-c Anesthesia System (Product Code 6887700) Flow-e Anesthesia System (Product Code 6887900)
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 expected run time in the event of a mains power…
FDA · DeviceGetinge Usa Sales IncUS Nationwide distribution in the states of CO, FL, IN, MA, MO, and VA.Official notice → - 2022-11-23
- US
Getinge Usa Sales Inc recalls Extension Tabletop for Operating Table System 1140, Model Nos. 1140.20F0 and 1140.20AN
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.
FDA · DeviceGetinge Usa Sales IncWorldwide - US Nationwide distribution in the states of MA, NJ, SC, and TN.…Official notice → - 2022-08-31
- US
Getinge Usa Sales Inc recalls Servo-air Ventilator System-The Servo-air Ventilator System is: Intended for respiratory support, monitoring and treatment of pediatric…
Device does not meet regulatory requirements of stability while stationary, which requires mechanical equipment, other than fixed mechanical equipment, that is intended to be used on the floor or on a table shall be…
FDA · DeviceGetinge Usa Sales IncWorldwide distribution - US Nationwide and the countries of Australia (AU),…Official notice → - US
Getinge Usa Sales Inc recalls Maquet Critical Care AB/Getinge Servo-u Ventilator System, Part Number 6694800 Servo-n Ventilator System, Part Number 6688600 Servo-u MR…
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 stops ventilating due to this issue, it may lead to…
FDA · DeviceGetinge Usa Sales IncWorldwide distribution. US nationwide, Poland, Spain, France, Germany, Czech…Official notice → - 2022-07-06
- US
Getinge Usa Sales Inc recalls VOLISTA StandOP Surgical Light, Product Code/Part Numbers ARD568811901 VLT600SF AIM STP ARD568811911 VLT600SF AIM STP ARD568811961…
Paint particles may detach and fall in the operating field. In the worst case scenario, infection, organ irritation, hypersensitivity reaction, and tissue granuloma may result if paint particles fall during surgical…
FDA · DeviceGetinge Usa Sales IncWorldwide distribution - US Nationwide distribution in the states of AR, AZ,…Official notice → - 2022-06-29
- US
Getinge Usa Sales Inc recalls Flow-c Anesthesia System : intended for use in administering anesthesia while controlling the entire ventilation of patient Product…
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 break, preventing the suction unit from being…
FDA · DeviceGetinge Usa Sales IncUS Distribution in states of Colorado, Florida, New Jersey, Indiana, Missouri,…Official notice → - 2022-06-15
- US
Getinge Usa Sales Inc recalls Getinge CM320 WUWD Series Washer Disinfector-For use as a multi-chamber washer-disinfector for the washing, disinfecting and drying…
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 pinch injury or slip and fall injury. May lead to a…
FDA · DeviceGetinge Usa Sales IncUS Nationwide distribution in the states of MD, MN, ND, NE, NY, PA, VA.Official notice → - 2022-05-25
- US
Getinge Usa Sales Inc recalls Getinge 9100-Series Washer Disinfector models: 9120E, 9125E, 9127E, 9128E, 9122EW, 9128EW.
Inadequate documentation verifying whether device installation has been executed in accordance with the manufacturer's requirements. This can lead to installation failure modes and hazardous situations.
FDA · DeviceGetinge Usa Sales IncWorldwide distribution: (US) AZ, CA, CO, CT, DC, FL, GA, ID, IL, IN, KY, LA,…Official notice → - 2022-01-19
- US
Getinge Usa Sales Inc recalls Vaporizer Sevoflurane Maquet Filling, Part No. 6886601 Component of the following systems: Product Code(s) UPN/UDI: Flow-c Anesthesia…
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 hydrogen fluoride.
FDA · DeviceGetinge Usa Sales IncWorldwide distribution - US Nationwide distribution in the states of VA and…Official notice →