FDA Medical Device Recalls (openFDA)
DATEX--OHMEDA, INC.: GE Heathcare Giraffe OmniBed; neo natal incubator
- Recall number
- Z-0047-2025
- Recalling firm
- DATEX--OHMEDA, INC.
- Product
- GE Heathcare Giraffe OmniBed; neo natal incubator
- Status
- Open, Classified
- Initiated
- 2024-09-03
- Posted
- 2024-10-17
- Terminated
- not on file
- 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.
- Root cause
- Use error
- Action
- GE HealthCare issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 09/03/2024 via Fed-Ex. The notice explained the problem with the device, safety issue, and requested the following: Download the Service Manual Addendum (5971733) from the GE HealthCare Customer Documentation Portal: https://www.gehealthcare.com/support/manuals. Inspect the heater door mounting screw on your device. If the screw is not appropriately tightened, complete steps 9 and 10 of Section 1.1 of the Service Manual Addendum (5971733).
- Quantity
- not on file
- Distribution
- Worldwide distribution.
- Lot, serial or model codes
- All models
- 510(k) numbers
- ["K101788","K020543"]
- PMA numbers
- not on file
- Product code
- FMZ
- Firm FEI
- 3014220748
- Firm city
- Wauwatosa
- Firm state
- WI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28