GE Heathcare Giraffe OmniBed Carestation — Class I medical device recall Z-0048-2025
Ongoing recall by DATEX--OHMEDA, INC., reported 2024-10-23. GE HealthCare has become aware that for certain Giraffe OmniBed and Giraffe OmniBed Carestation devices, the s
| Recall number | Z-0048-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | DATEX--OHMEDA, INC., Wauwatosa, WI, United States |
| Recall initiated | 2024-09-03 |
| Classified | 2024-10-17 |
| Reported by FDA | 2024-10-23 |
| Model numbers | 2082844-001-XXX |
Product
GE Heathcare Giraffe OmniBed Carestation, Model Number 2082844-001-XXX; neo natal incubator
Reason for recall
GE HealthCare has become aware that for certain Giraffe OmniBed and Giraffe OmniBed Carestation devices, the screw that secures the doors that cover the warmer heaters may not have been torqued to specification. This may lead to the doors becoming loose.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0048-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.