Giraffe OmniBed (GE Healthcare) – Door Screw Loose (2024)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
GE Heathcare Giraffe OmniBed; neo natal incubator
Brand
DATEX--OHMEDA, INC.
Lot Codes / Batch Numbers
All models
Products Sold
All models
DATEX--OHMEDA, INC. is recalling GE Heathcare Giraffe OmniBed; neo natal incubator due to GE HealthCare has become aware that for certain Giraffe OmniBed and Giraffe OmniBed Carestation devices, the screw that secures the doors that cover t. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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).
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026