Class I
Medical Device Recall: GE Heathcare Giraffe OmniBed Carestation, Model Number 2082844-001-XXX; neo natal incubator
DATEX--OHMEDA, INC. · September 3, 2024
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.
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0048-2025
Status: ongoing
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