Z-0048-2025Class I

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

Name: Z-0048-2025 GE Heathcare Giraffe OmniBed Carestation, Model Number 2082844-001-XXX; neo natal incubator
Creator: Datex--Ohmeda, Inc.
Published: 2024-09-03
License: https://open.fda.gov/license/

GE Healthcare / initiated 2024-09-03 / Open, Classified

FDA source

DATEX--OHMEDA, INC. began a recall of GE Heathcare Giraffe OmniBed Carestation, Model Number 2082844-001-XXX; neo natal incubator on 2024-09-03. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0048-2025
Classification: Class I
Status: Open, Classified
Initiated: 2024-09-03
Posted: 2024-10-17
Recalling firm: GE Healthcare
Product: GE Heathcare Giraffe OmniBed Carestation, Model Number 2082844-001-XXX; neo natal incubator
Product code: FMZ Incubator, Neonatal
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.
FDA 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).
Distribution: Worldwide distribution.
Product codes and lots: All models

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0048-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0047-2025	Class I	Ongoing	Voluntary: Firm initiated	2024-10-23	2024-10-17
Z-0048-2025	Class I	Ongoing	Voluntary: Firm initiated	2024-10-23	2024-10-17

Product code FMZ

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)