Skip to content
Recall Observatory FDA recall evidence

Device product

GE Heathcare Giraffe OmniBed Carestation, Model Number 2082844-001-XXX; neo natal incubator

Z-0048-2025

September 03, 2024

Class I

Product summary

Firm
DATEX--OHMEDA, INC.
Event
Event 95282
Status
Ongoing
Classification
Class I
Quantity
Unavailable
Official record key
device-enforcement:Z-0048-2025

Official wording

Reason: 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.

Code information: All models

Distribution pattern: Worldwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.