Getinge Usa Sales Inc Recalls
33 recalls from federal safety databases (FDA, CPSC). Sourced directly from government enforcement feeds.
Medical Device Recalls (33)
- Class I
January 15, 2025
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 use during anesthesia.
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 respiratory tract, which in worst case may lead to lung edema and/or severe hypocalcemia, blistering, superficial ulceration, and/or hypomagnesemia.
- Class II
October 3, 2024
MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during and after surgical interventions, as well as for examination and treatment Item
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 result in procedural delay
- Class II
October 3, 2024
MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during and after surgical interventions, as well as for examination and treatment Item
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 result in procedural delay
- Class II
October 3, 2024
MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during and after surgical interventions, as well as for examination and treatment Item
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 result in procedural delay
- Class II
October 3, 2024
MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during and after surgical interventions, as well as for examination and treatment Item
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 result in procedural delay
- Class II
October 3, 2024
MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during and after surgical interventions, as well as for examination and treatment Item
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 result in procedural delay
- Class II
October 3, 2024
MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during and after surgical interventions, as well as for examination and treatment Item
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 result in procedural delay
- Class II
October 3, 2024
MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during and after surgical interventions, as well as for examination and treatment Item
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 result in procedural delay
- Class II
October 3, 2024
MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during and after surgical interventions, as well as for examination and treatment, Item
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 result in procedural delay
- Class II
May 29, 2024
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 failure.
- Class II
May 29, 2024
ALPHAMAXX Mobile Operating Table, Model Number/Part Number: 113322F5
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 failure.
- Class II
May 29, 2024
ALPHAMAXX Mobile Operating Table, Model Number/Part Number: 113322B5
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 failure.
- Class I
May 1, 2024
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 respiratory tract, which in worst case may lead to lung edema and/or severe hypocalcemia, blistering, superficial ulceration, and/or hypomagnesemia.
- Class II
December 11, 2023
Flow-e Anesthesia System, model 6887900
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 situation.
- Class II
December 11, 2023
Flow-i C40 Anesthesia System, model 6677400
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 situation.
- Class II
December 11, 2023
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 situation.
- Class II
December 11, 2023
Flow-i C20 Anesthesia System, model 6677200
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 situation.
- Class II
December 11, 2023
Flow-i C30 Anesthesia System, model 6677300
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 situation.
- Class II
November 8, 2023
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 - ARD567221211
A potential for a light system to fall in the operating room.
- Class II
November 8, 2023
Maquet Orchide OR Light Systems, Model Numbers and Catalog Numbers OHDII FHD QL VP01 - ARD568803935, OHDII FHD QL AIR03 U - ARD568803952, OHDII FHD QL AIR03 E - ARD568803967, OHDII FHD QL AIR04 E/U -
A potential for a light system to fall in the operating room.
- Class II
November 8, 2023
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, RO
A potential for a light system to fall in the operating room.
- Class II
November 8, 2023
Maquet Hanaulux HLX3000 OR Light Systems, Model Numbers and Catalog Numbers H3 BC - HM567811111C
A potential for a light system to fall in the operating room.
- Class II
November 8, 2023
Maquet Lucea - Lucea10/40, Lucea50/100 OR Light Systems, Model Numbers and Catalog Numbers LCA 10 - ARD2LCA00040C, LCA 10 - ARDLCA109000C, LCA 10 - ARDLCA109002C, LCA 10 - ARDLCA109006C, LCA 10 - ARDL
A potential for a light system to fall in the operating room.
- Class II
November 8, 2023
Maquet PowerLED/HLED and PowerLED300 OR Light Systems, Model Numbers and Catalog Numbers EPS MB1 - ARDINT059002A, EPS MB1 - ARDINT059002C, EPS MB1 TR - ARDINT059000A, EPS MB1 TR - ARDINT059000C, EPS M
A potential for a light system to fall in the operating room.
- Class II
November 8, 2023
Maquet Hanaulux 2006/ 2007, Blue 100, Blue 130/ 90, Blue Series 30/ 80, and Prismatic OR Light Systems. No Model Numbers.
A potential for a light system to fall in the operating room.
- Class II
November 8, 2023
Maquet PowerLEDII OR Light System, Model Names and Catalog Numbers PWDII77SF - ARDPWT629100A, PWDII555DF - ARDPWT629101A, PWDII555SF - ARDPWT629102A, PWDII755DF - ARDPWT629103A, PWDII755SF - ARDPWT629
A potential for a light system to fall in the operating room.
- Class II
November 8, 2023
Maquet XTen OR Light Systems, Model Numbers and Catalog Numbers 3001 HMD14 - ARD567732001C, X TEN DUO - ARD568221510C, X TEN DUO - ARD568221561C, X10AXL DF - ARD568211010C, X10AXL SF - ARD568231010C,
A potential for a light system to fall in the operating room.
- Class II
November 8, 2023
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 - ARD569025
A potential for a light system to fall in the operating room.
- Class II
November 8, 2023
Maquet Rolite OR Light Systems, Model Numbers and Catalog Numbers ROL PWDII50SF - ARDPWT309001A, ROL PWDII50SF - ARDPWT309002A, ROL PWDII50SF - ARDPWT309009A, ROL PWDII50SF - ARDPWT309010A, ROL PWDII7
A potential for a light system to fall in the operating room.
- Class II
November 8, 2023
Maquet Equipment OR Light Systems, Model Numbers and Catalog Numbers BRAINLAB CAMERA - ARDEQT269000A, BRAINLAB CAMERA - ARDEQT269000C, BRAINLAB CAMERA - ARDEQT269001A, BRAINLAB CAMERA - ARDEQT269001C,
A potential for a light system to fall in the operating room.
- Class II
November 8, 2023
Maquet G8 / G8E OR Light Systems, Model Numbers and Catalog Numbers G8 LC E - ARD568131211C, G8G8 DF E - ARD568121111C, G8G8FS DF - ARD568121131C
A potential for a light system to fall in the operating room.
- Class II
November 8, 2023
Maquet Axcel / Axcel + OR Light Systems, Model Numbers and Catalog Numbers AXL 5001 - ARD567501961C, AXL 5001S - ARD567505961C, AXL 5002 - ARD567501962C, AXL 5002S - ARD567505962C, AXL 5501 - ARD56750
A potential for a light system to fall in the operating room.
- Class II
November 8, 2023
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 - ARD56
A potential for a light system to fall in the operating room.
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.