FDA-Device2024-10-23Class I
GE Heathcare Giraffe OmniBed; neo natal incubator
DATEX--OHMEDA, INC.
Hazard
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.
Sold states
Worldwide distribution.
Manufactured in
9900 W Innovation Dr, Wauwatosa, WI, United States
Products
GE Heathcare Giraffe OmniBed; neo natal incubator
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0047-2025Don't want to check this manually?
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