Recall Z-0048-2025
Datex--Ohmeda, Inc. · initiated September 3, 2024
Class I – dangerous or defective products that could cause serious health problems or death
Product
GE Heathcare Giraffe OmniBed Carestation, Model Number 2082844-001-XXX; neo natal incubator
Codes / lots: All models
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.
FDA-determined cause: Use error
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).
Details
- Recall number
- Z-0048-2025
- Initiated
- September 3, 2024
- Posted by FDA
- October 17, 2024
- Product code
- FMZ – Incubator, Neonatal
- Distribution
- Worldwide distribution.
- Recalling firm
- Datex--Ohmeda, Inc., Wauwatosa, WI
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0047-2025 Class I | GE Heathcare Giraffe OmniBed; neo natal incubatorGE HealthCare has become aware that for certain Giraffe OmniBed and Giraffe OmniBed Carestation devices, the… | 09/03/2024Open, Classified |