FDAFDA · Food and drugs·Recall number Z-0048-2025
GE Heathcare Giraffe OmniBed Carestation, Model Number 2082844-001-XXX; neo natal incubator
Published October 23, 2024 · Recall initiated: September 3, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- DATEX--OHMEDA, INC.
- Distributor
- Worldwide distribution.
- Lot
- All models
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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