Recall Z-0048-2025 ยท FMZ Incubator, Neonatal
DATEX--OHMEDA, INC.
GE Heathcare Giraffe OmniBed Carestation, Model Number 2082844-001-XXX; neo natal incubator
| Date | Oct 17, 2024 (initiated Sep 3, 2024) |
| Status | Open, Classified |
| 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. |
| Root cause | Use error |
| Action | 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). |
| Distribution | Worldwide distribution. |
| FDA record | Open on fda.gov |