GE Heathcare Giraffe OmniBed Carestation, Model Number 2082844-001-XXX; neo natal incubator
This recall is currently active, issued October 17, 2024. It was issued by Datex--Ohmeda, Inc..
- Company
- Datex--Ohmeda, Inc.
- Recall Initiated
- September 3, 2024
- Posted
- October 17, 2024
- Recall Number
- Z-0048-2025
- Firm Location
- Wauwatosa, WI
- Official Source
- View on FDA website ↗
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.
Distribution
Worldwide distribution.
Lot / Code Info
All models
Root 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).