DATEX--OHMEDA, INC.

FDA Regulatory Profile

Summary

Total Recalls
7 (4 Class I)
510(k) Clearances
0
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0047-2025Class IGE Heathcare Giraffe OmniBed; neo natal incubatorSeptember 3, 2024
Z-0048-2025Class IGE Heathcare Giraffe OmniBed Carestation, Model Number 2082844-001-XXX; neo natal incubatorSeptember 3, 2024
Z-0141-2025Class IGE Healthcare Giraffe Incubator Carestation CS1, Infant Incubator. Model Numbers: 1) 2082844-002-June 6, 2023
Z-0140-2025Class IGE Healthcare Giraffe Omnibed Carestation CS1, combination infant incubator and infant warmer. ModelJune 6, 2023
Z-2100-2023Class IIGiraffe OmniBed Carestation CS1, Model Numbers: a. 2082844-001-XXX, b. 2074920-001-XXXXXX, c. MMay 19, 2023
Z-2101-2023Class IIGiraffe OmniBed, with the following Model Numbers: 6650-0004-901, 6650-0001-901, 6650-0003-901, 6650May 19, 2023
Z-2102-2023Class IIBeside panel FRU (Field Replacement Units) KitsMay 19, 2023