GE Heathcare Giraffe OmniBed Carestation, Model Number 2082844-001-XXX; neo natal incubator
FDA Recall #Z-0048-2025 — Class I — September 3, 2024
Product Description
GE Heathcare Giraffe OmniBed Carestation, Model Number 2082844-001-XXX; neo natal incubator
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.
Recalling Firm
DATEX--OHMEDA, INC. — Wauwatosa, WI
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Devices
Distribution
Worldwide distribution.
Code Information
All models
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated