Getinge Usa Sales Inc

FDA Regulatory Profile

Summary

Total Recalls
48 (9 Class I)
510(k) Clearances
0
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1074-2025Class IVaporizer Sevoflurane, Quik-Fil. Model Number: 6682285. Device is a component of Flow-i C20, Flow-iJanuary 15, 2025
Z-0462-2025Class IIMEERA CL mobile operating table - Designed for the placement and positioning of the patient immediatOctober 3, 2024
Z-0457-2025Class IIMEERA CL mobile operating table - Designed for the placement and positioning of the patient immediatOctober 3, 2024
Z-0461-2025Class IIMEERA CL mobile operating table - Designed for the placement and positioning of the patient immediatOctober 3, 2024
Z-0456-2025Class IIMEERA CL mobile operating table - Designed for the placement and positioning of the patient immediatOctober 3, 2024
Z-0458-2025Class IIMEERA CL mobile operating table - Designed for the placement and positioning of the patient immediatOctober 3, 2024
Z-0463-2025Class IIMEERA CL mobile operating table - Designed for the placement and positioning of the patient immediatOctober 3, 2024
Z-0460-2025Class IIMEERA CL mobile operating table - Designed for the placement and positioning of the patient immediatOctober 3, 2024
Z-0459-2025Class IIMEERA CL mobile operating table - Designed for the placement and positioning of the patient immediatOctober 3, 2024
Z-2271-2024Class IIALPHAMAXX Mobile Operating Table, Model Number/Part Number: 113322B4May 29, 2024
Z-2272-2024Class IIALPHAMAXX Mobile Operating Table, Model Number/Part Number: 113322B5May 29, 2024
Z-2273-2024Class IIALPHAMAXX Mobile Operating Table, Model Number/Part Number: 113322F5May 29, 2024
Z-1877-2024Class IVaporizer Sevoflurane Maquet Filling, Product code/REF number (6682282), Component of: Flow-i C20, FMay 1, 2024
Z-0989-2024Class IIFlow-i C40 Anesthesia System, model 6677400December 11, 2023
Z-0987-2024Class IIFlow-i C20 Anesthesia System, model 6677200December 11, 2023
Z-0990-2024Class IIFlow-c Anesthesia System, model 6887700December 11, 2023
Z-0988-2024Class IIFlow-i C30 Anesthesia System, model 6677300December 11, 2023
Z-0991-2024Class IIFlow-e Anesthesia System, model 6887900December 11, 2023
Z-0763-2024Class IIMaquet PowerLED/HLED and PowerLED300 OR Light Systems, Model Numbers and Catalog Numbers EPS MB1 - ANovember 8, 2023
Z-0760-2024Class IIMaquet Rolite OR Light Systems, Model Numbers and Catalog Numbers ROL PWDII50SF - ARDPWT309001A, ROLNovember 8, 2023