DATEX--OHMEDA, INC.
DATEX--OHMEDA, INC. appears in FDA public data with 7 recalls — including 4 Class I (most serious) —, 0 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0047-2025, Class I) was initiated on September 3, 2024.
Summary
- Total Recalls
- 7 (4 Class I)
- 510(k) Clearances
- 0
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-0047-2025 | Class I | GE Heathcare Giraffe OmniBed; neo natal incubator | September 3, 2024 |
| Z-0048-2025 | Class I | GE Heathcare Giraffe OmniBed Carestation, Model Number 2082844-001-XXX; neo natal incubator | September 3, 2024 |
| Z-0141-2025 | Class I | GE Healthcare Giraffe Incubator Carestation CS1, Infant Incubator. Model Numbers: 1) 2082844-002- | June 6, 2023 |
| Z-0140-2025 | Class I | GE Healthcare Giraffe Omnibed Carestation CS1, combination infant incubator and infant warmer. Model | June 6, 2023 |
| Z-2100-2023 | Class II | Giraffe OmniBed Carestation CS1, Model Numbers: a. 2082844-001-XXX, b. 2074920-001-XXXXXX, c. M | May 19, 2023 |
| Z-2101-2023 | Class II | Giraffe OmniBed, with the following Model Numbers: 6650-0004-901, 6650-0001-901, 6650-0003-901, 6650 | May 19, 2023 |
| Z-2102-2023 | Class II | Beside panel FRU (Field Replacement Units) Kits | May 19, 2023 |