The Recall Desk

Manufacturer

Getinge Usa Sales Inc

46 recalls in our database name Getinge Usa Sales Inc as the manufacturing or recalling firm.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

26–46 of 46

  • HighFDA (Devices)·Z-0760-2024·2024-01-24

    Maquet Rolite OR Light Systems Recall Due to Fall Risk

    Getinge USA is recalling 236,793 Maquet Rolite operating room light systems due to a potential for the light fixture to fall. No injuries have been reported.

    Product
    Maquet Rolite OR Light Systems, Model Numbers and Catalog Numbers ROL PWDII50SF - ARDPWT309001A, ROL PWDII50SF - ARDPWT309002A, ROL PWDII50SF - ARDPWT309009A, ROL PWDII50SF - ARDPWT309010A, ROL PWDII70SF - ARDPWT309007A, ROL PWDII70SF - ARDPWT309008A, ROL PWDII70SF - ARDPWT309015
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0765-2024·2024-01-24

    Maquet Hanaulux HLX3000 Operating Room Light Systems Recall for Fall Hazard

    Getinge Usa Sales Inc is recalling approximately 236,793 Maquet Hanaulux HLX3000 operating room light systems nationwide and globally due to a potential for the light system to fall in the operating room.

    Product
    Maquet Hanaulux HLX3000 OR Light Systems, Model Numbers and Catalog Numbers H3 BC - HM567811111C
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0758-2024·2024-01-24

    Maquet Volista OR Light Systems Recalled for Fall Hazard

    Getinge is recalling Maquet Volista OR light systems that may fall during use in operating rooms. Approximately 236,793 units are affected nationwide and globally.

    Product
    Maquet Volista, Volista Access, Volista Access II, Volista Standop OR Light System, Model Numbers and Catalog Numbers ROL B FOR VLT400SF STP - ARDROL309001A, ROL B FOR VLT400SF STP - ARDROL309001C, ROL B FOR VLT600SF STP - ARDROL309003A, ROL B FOR VLT600SF STP - ARDROL309003C, RO
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0770-2024·2024-01-24

    Maquet Blueline Series OR Light Systems Recalled Due to Fall Risk

    Getinge Usa Sales Inc is recalling Maquet Blueline Series 30/80 operating room light systems that may fall in the operating room. No injuries have been reported.

    Product
    Maquet Blueline Series 30/80 OR Light Systems, Model Numbers and Catalog Numbers BLUE 30 - ARD569015111A, BLUE 30 - ARD569015111C, BLUE 30 - ARD569015131C, BLUE 30 - ARD569025111C, BLUE 30 - ARD569025131C, BLUE 30 - ARD569035111C, BLUE 30 - ARD569035131C, BLUE 30 - ARD569045111C,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0767-2024·2024-01-24

    Maquet Prismalix OR Light Systems recalled due to fall hazard

    Getinge has recalled 236,793 Maquet Prismalix operating room light systems because the systems could potentially fall. The recall affects units distributed nationwide in the U.S. and globally.

    Product
    Maquet Prismalix OR Light Systems, Model Numbers and Catalog Numbers 3001 - ARD567424001C, 3001 HMS07 - ARD567722001C, 3001 HXS12 - ARD567703001C, 4001 S/DF - ARD567211211C, 4001 SAD/DF - ARD567221211C, 4001 SAD/DF - ARD567221241C, 4001 SAD/SF - ARD567221141C, 4001 SAI/DF - ARD56
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0768-2024·2024-01-24

    Maquet Hanaulux HLX2000 Operating Room Lights Recalled Due to Fall Hazard

    Getinge Usa Sales Inc is recalling Maquet Hanaulux HLX2000 OR Light Systems because the light fixture may fall from its mounting in the operating room. Nearly 237,000 units are affected.

    Product
    Maquet Hanaulux HLX2000 OR Light Systems, Model Numbers and Catalog Numbers 3001 - ARD567424001C, 3001 HMS07 - ARD567722001C, 3001 HXS12 - ARD567703001C, 4001 S/DF - ARD567211211C, 4001 SAD/DF - ARD567221211C, 4001 SAD/DF - ARD567221241C, 4001 SAD/SF - ARD567221141C, 4001 SAI/DF
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0036-2024·2023-10-11

    Meera Mobile Operating Table May Move Unexpectedly During Surgery

    Getinge is recalling the Meera Mobile Operating Table due to unintended movement that could occur during surgery. 224 units nationwide are affected.

    Product
    Meera Mobile Operating Table-to support and position the patient immediately before, during and after surgical interventions as well as for examination and treatment. Model Number: 7200.01F2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0961-2023·2023-02-01

    Getinge Flow-e Anesthesia System Software Defect Prevents Patient Ventilation

    Getinge Flow-e Anesthesia System units with certain software versions contain a bug that can prevent pressure buildup and ventilation delivery. This may result in inadequate oxygen delivery and hypoxia in anesthesia patients.

    Product
    Getinge Flow-e Anesthesia System, Part No. 6887900
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0960-2023·2023-02-01

    Getinge Flow-c Anesthesia System Software Bug May Prevent Ventilation

    The Getinge Flow-c Anesthesia System contains a software bug that can prevent pressure buildup and ventilation delivery. Under certain conditions, oxygen delivery may decrease, which may lead to hypoventilation and hypoxia.

    Product
    Getinge Flow-c Anesthesia System, Part No. 6887700
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0959-2023·2023-02-01

    Getinge Flow-i Anesthesia Systems Recalled for Software Ventilation Defect

    Getinge Flow-i Anesthesia Systems models C20, C30, and C40 are being recalled due to a software bug that can prevent proper ventilation, potentially leading to hypoxia in patients.

    Product
    Getinge Flow-i Anesthesia Systems Flow-i C20, Part no. 6677200 Flow-i C30, Part no. 6677300 Flow-i C40, Part no. 6677400
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0422-2023·2022-12-14

    Getinge Flow-c and Flow-e Anesthesia Systems: Backup Battery Failure Risk

    Getinge Flow-c and Flow-e anesthesia systems are recalled due to backup battery defects that may fail during power outages, potentially requiring manual emergency ventilation. 65 units affected in six US states.

    Product
    Flow-c Anesthesia System (Product Code 6887700) Flow-e Anesthesia System (Product Code 6887900)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0239-2023·2022-11-23

    Operating Table Extension Tabletop May Drop, Creating Patient Fall Hazard

    The back rest of Getinge operating table extension tabletops may drop unexpectedly, posing a fall hazard to patients. No injuries have been reported.

    Product
    Extension Tabletop for Operating Table System 1140, Model Nos. 1140.20F0 and 1140.20AN
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1560-2022·2022-08-31

    Getinge Servo ventilator systems recalled for loss of ventilation

    Getinge Servo ventilators may fail to deliver ventilation and stop functioning, potentially causing oxygen deprivation and serious harm to critical care patients.

    Product
    Maquet Critical Care AB/Getinge Servo-u Ventilator System, Part Number 6694800 Servo-n Ventilator System, Part Number 6688600 Servo-u MR ventilator: Part Number 6888800 Servo-air: Part Number 6882000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1568-2022·2022-08-31

    Servo-air Ventilator Systems Lack Required Stability Warning Markings

    Getinge is recalling Servo-air Ventilator Systems because they lack required warning markings about stability risks when stationary. A total of 102 units were distributed in the US; 13,750 units were distributed internationally.

    Product
    Servo-air Ventilator System-The Servo-air Ventilator System is: Intended for respiratory support, monitoring and treatment of pediatric and adult patients. Model Number: 6882000 (equipped with 6881999 mobile cart)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1308-2022·2022-07-06

    Surgical Light Paint Particles May Fall Into Operating Field

    Paint particles may detach from VOLISTA StandOP Surgical Lights and fall into the operating field during surgery, risking infection and organ irritation. Getinge Usa Sales Inc is recalling 337 affected units in the United States.

    Product
    VOLISTA StandOP Surgical Light, Product Code/Part Numbers ARD568811901 VLT600SF AIM STP ARD568811911 VLT600SF AIM STP ARD568811961 VLT600DF AIM STP ARDVST229000A VST60SF AIM ARDVST229001A VST60DF AIM ARDVST229002A VST66SF AIM ARDVST229003A VST66DF AIM ARDVST229034A VST60SF
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1278-2022·2022-06-29

    Anesthesia System Suction Switch Crack Recall: Potential Equipment Failure

    Getinge is recalling 17 Flow-c Anesthesia Systems due to cracks that may develop on the suction unit's on/off switch, potentially preventing the switch from activating and posing a risk to patients.

    Product
    Flow-c Anesthesia System : intended for use in administering anesthesia while controlling the entire ventilation of patient Product Code/REF Number: 6887700
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1279-2022·2022-06-29

    Anesthesia system suction switch may crack and fail to activate

    Getinge Flow-e Anesthesia System units may have a crack forming on the suction unit's on/off switch, which could break and prevent the suction from being activated, potentially harming patients.

    Product
    Flow-e Anesthesia System : Intended for use in administering anesthesia while controlling the entire ventilation of patient Product Code/REF Number: 6887900
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1248-2022·2022-06-15

    Getinge CM320-2 Surgical Instrument Washer Disinfector Recalled for Incomplete Installation Verification

    Getinge recalls its CM320-2 washer disinfector due to unverified or incomplete installation, which could cause skin burns, electric shock, smoke inhalation, or crush injuries. Four units were distributed across seven US states.

    Product
    Getinge CM320-2 CHAMBER WU Series Washer Disinfector- For Use as a multi-chamber washer-disinfector for the washing, disinfecting and drying surgical instruments, etc. Model: CM320 WU
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1249-2022·2022-06-15

    Getinge CM320 WUWD Washer Disinfector Installation Verification Issue Recall

    The FDA is recalling 11 Getinge CM320 WUWD washer-disinfectors used for surgical instrument processing. Installation verification was not properly documented or completed, potentially creating risks of electrical shock, burns, and other injuries.

    Product
    Getinge CM320 WUWD Series Washer Disinfector-For use as a multi-chamber washer-disinfector for the washing, disinfecting and drying surgical instruments, Model: CM320 WUWD
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1078-2022·2022-05-25

    Getinge Washer Disinfector models recalled for inadequate installation documentation

    Getinge USA is recalling 127 Washer Disinfector models worldwide due to inadequate documentation verifying proper installation. The issue could lead to installation failures and potentially hazardous situations.

    Product
    Getinge 9100-Series Washer Disinfector models: 9120E, 9125E, 9127E, 9128E, 9122EW, 9128EW.
    Category
    Medical Device
    Distribution
    34 states
  • SevereFDA (Devices)·Z-0468-2022·2022-01-19

    Maquet Sevoflurane vaporizer filling recalled due to potential hydrogen fluoride exposure

    Getinge Usa Sales Inc recalls Vaporizer Sevoflurane components in anesthesia systems due to potential chemical degradation that may cause hydrogen fluoride exposure via inhalation or skin contact.

    Product
    Vaporizer Sevoflurane Maquet Filling, Part No. 6886601 Component of the following systems: Product Code(s) UPN/UDI: Flow-c Anesthesia System 6887700 07325710009765 Flow-e Anesthesia System 6887900 07325710010457 Flow-i Anesthesia System C20 6888520 07325710010617 Flow-i
    Category
    Medical Device
    Distribution
    Distributed nationwide