FDA Device recall Z-0048-2025
GE Heathcare Giraffe OmniBed Carestation, Model Number 2082844-001-XXX
- FDA Device
- Class I
- ongoing
- Published 2024-10-23
On 2024-10-23 the FDA classified a Class I recall of GE Heathcare Giraffe OmniBed Carestation, Model Number 2082844-001-XXX by Datex Ohmeda, citing 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 hav….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0048-2025 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2024-09-03 |
| Published | 2024-10-23 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Datex Ohmeda |
| Distribution | n/a |
Product
GE Heathcare Giraffe OmniBed Carestation, Model Number 2082844-001-XXX; neo natal incubator
Reason
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.
Identifiers
| code_info | All models |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0048-2025%22
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