GE Heathcare Giraffe OmniBed; neo natal incubator
FDA device recall Z-0047-2025 · posted 2024-10-17 · Open, Classified
Recall details
- Recalling firm
- DATEX--OHMEDA, INC.
- 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.
- Action taken
- GE HealthCare issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 09/03/2024 via Fed-Ex. The notice explained the problem with the device, safety issue, and requested the following: Download the Service Manual Addendum (5971733) from the GE HealthCare Customer Documentation Portal: https://www.gehealthcare.com/support/manuals. Inspect the heater door mounting screw on your device. If the screw is not appropriately tightened, complete steps 9 and 10 of Section 1.1 of the Service Manual Addendum (5971733).
- Root cause
- Use error
- Status
- Open, Classified
- Product code
- FMZ
- Distribution
- Worldwide distribution.
- Date initiated
- 2024-09-03
- Date posted
- 2024-10-17
- Location
- Wauwatosa, WI
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GIRAFFE OMNIBED (K101788) | Ohmeda Medical | 2010-07-21 |
| OHMEDA MEDICAL GIRAFFE OMNIBED (K020543) | Ohmeda Medical | 2002-05-09 |