FDA recall record · openFDA
Getinge Usa Sales Inc
34 FDA recalls on record (2023–2025) — 34 device. 34 still ongoing.
2
Class I (most serious)
32
Class II
0
Class III
34
ongoing
How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.
Most common reasons
A potential for a light system to fall in the operating room. 15
Error code "50037" occurs on the IR-Hand Control when a MEERA-table is controlled, and the table stops the movement. Thi 8
Potential cybersecurity vulnerability that could lead to a Denial of Service (DoS) attack, tampering, or remote code exe 5
The recall is prompted by a defective charger unit (0970.2873) for models 1133.22B4, 1133.22B5, and 1133.22F5 of the ALP 3
Sevoflurane used with the vaporizer may degrade to hydrogen fluoride, which could present a risk to patients or health c 2
Recalls
Vaporizer Sevoflurane, Quik-Fil. Model Number: 6682285. Device is a component of Flow-i C20, Flow-i C30, Flow-i C40, Fl Class I 2025-01-15 Vaporizer Sevoflurane Maquet Filling, Product code/REF number (6682282), Component of: Flow-i C20, Flow-i C30,Flow-i C40 Class I 2024-05-01 MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during a Class II 2024-10-03 ALPHAMAXX Mobile Operating Table, Model Number/Part Number: 113322B4 Class II 2024-05-29 ALPHAMAXX Mobile Operating Table, Model Number/Part Number: 113322F5 Class II 2024-05-29 ALPHAMAXX Mobile Operating Table, Model Number/Part Number: 113322B5 Class II 2024-05-29 MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during a Class II 2024-10-03 MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during a Class II 2024-10-03 MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during a Class II 2024-10-03 MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during a Class II 2024-10-03 MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during a Class II 2024-10-03 MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during a Class II 2024-10-03 MEERA CL mobile operating table - Designed for the placement and positioning of the patient immediately before, during a Class II 2024-10-03 Maquet PowerLED/HLED and PowerLED300 OR Light Systems, Model Numbers and Catalog Numbers EPS MB1 - ARDINT059002A, EPS MB Class II 2023-11-08 Maquet Blueline Series 30/80 OR Light Systems, Model Numbers and Catalog Numbers BLUE 30 - ARD569015111A, BLUE 30 - ARD5 Class II 2023-11-08 Maquet Rolite OR Light Systems, Model Numbers and Catalog Numbers ROL PWDII50SF - ARDPWT309001A, ROL PWDII50SF - ARDPWT3 Class II 2023-11-08 Flow-c Anesthesia System, model 6887700 Class II 2023-12-11 Maquet Lucea - Lucea10/40, Lucea50/100 OR Light Systems, Model Numbers and Catalog Numbers LCA 10 - ARD2LCA00040C, LCA 1 Class II 2023-11-08 Maquet PowerLEDII OR Light System, Model Names and Catalog Numbers PWDII77SF - ARDPWT629100A, PWDII555DF - ARDPWT629101A Class II 2023-11-08 Flow-i C20 Anesthesia System, model 6677200 Class II 2023-12-11 Flow-e Anesthesia System, model 6887900 Class II 2023-12-11 Maquet Equipment OR Light Systems, Model Numbers and Catalog Numbers BRAINLAB CAMERA - ARDEQT269000A, BRAINLAB CAMERA - Class II 2023-11-08 Maquet Volista, Volista Access, Volista Access II, Volista Standop OR Light System, Model Numbers and Catalog Numbers RO Class II 2023-11-08 Maquet Hanaulux HLX3000 OR Light Systems, Model Numbers and Catalog Numbers H3 BC - HM567811111C Class II 2023-11-08 Maquet G8 / G8E OR Light Systems, Model Numbers and Catalog Numbers G8 LC E - ARD568131211C, G8G8 DF E - ARD568121111C, Class II 2023-11-08 Maquet Axcel / Axcel + OR Light Systems, Model Numbers and Catalog Numbers AXL 5001 - ARD567501961C, AXL 5001S - ARD5675 Class II 2023-11-08 Maquet Hanaulux HLX2000 OR Light Systems, Model Numbers and Catalog Numbers 3001 - ARD567424001C, 3001 HMS07 - ARD567722 Class II 2023-11-08 Flow-i C30 Anesthesia System, model 6677300 Class II 2023-12-11 Maquet Hanaulux 2006/ 2007, Blue 100, Blue 130/ 90, Blue Series 30/ 80, and Prismatic OR Light Systems. No Model Number Class II 2023-11-08 Maquet XTen OR Light Systems, Model Numbers and Catalog Numbers 3001 HMD14 - ARD567732001C, X TEN DUO - ARD568221510C, X Class II 2023-11-08 Maquet Prismalix OR Light Systems, Model Numbers and Catalog Numbers 3001 - ARD567424001C, 3001 HMS07 - ARD567722001C, 3 Class II 2023-11-08 Maquet Orchide OR Light Systems, Model Numbers and Catalog Numbers OHDII FHD QL VP01 - ARD568803935, OHDII FHD QL AIR03 Class II 2023-11-08 Flow-i C40 Anesthesia System, model 6677400 Class II 2023-12-11 Meera Mobile Operating Table-to support and position the patient immediately before, during and after surgical intervent Class II 2023-09-06
RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.