Z-0047-2025 Class I Ongoing
FDA device recall Z-0047-2025 was initiated by DATEX--OHMEDA, INC. on September 3, 2024 and is designated Class I. 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 spe… The recall status is ongoing.
Recall Details
- Product Type
- Devices
- Report Date
- October 23, 2024
- Initiation Date
- September 3, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
Product Description
GE Heathcare Giraffe OmniBed; 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.
Distribution Pattern
Worldwide distribution.
Code Information
All models