FDA recall, , Moderate risk
GE HealthCare Giraffe OmniBed Devices
The Giraffe OmniBed has a potential issue with the canopy soffit that could cause patient injury.
Summary by Recall Canary from the FDA notice
What happened
GE Medical Systems, LLC, of Waukesha, Wisconsin, is recalling Giraffe OmniBed Field Replaceable Units, Giraffe OmniBed All Models, and Giraffe OmniBed Carestations and Giraffe OmniBed Carestation CS1. The recall began May 1, 2026, and was added to the FDA's Enforcement Report on June 17, 2026.
GE HealthCare identified a potential issue where, under certain conditions such as impact during transport, fasteners securing the canopy soffit beneath the control panel end can disengage and fall into the patient compartment. Distribution is nationwide in the US.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
3 products
Affected if its UDI-DI is listed.
A UDI-DI is the device identifier printed with the barcode on the device label.
Giraffe OmniBed Field Replaceable Unit (FRU), Model Numbers 6600-1056-400 and 6600-1461-500
- UDI-DI
- 801057486
- 800977619
- 801093759
Giraffe OmniBed, a combination of an infant incubator and an infant warmer, All Models
Giraffe OmniBed Carestations and Giraffe OmniBed Carestation CS1, a combination of an infant incubator and an infant warmer, Model Numbers 2082844-001-XXX
Recall details
- Company began the recall
- Sold in
Worldwide - US Nationwide distribution.
- Company
- GE Medical Systems, LLCWaukesha, Wisconsin
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98986
- Recall numbers
- Z-2475-2026 to Z-2477-2026
All recalls from GE Medical Systems, LLC
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
