FDAFDA recall Z-2477-2026 · Jun 24, 2026
GE Medical Systems, LLC: Giraffe OmniBed Field Replaceable Unit (FRU) recall
Recall found
Product
Giraffe OmniBed Field Replaceable Unit (FRU), Model Numbers 6600-1056-400 and 6600-1461-500
Reason for recall
GE HealthCare has become aware of a potential issue involving the canopy soffit beneath the control panel end of the device. Under certain conditions, for example, impact during transport, one or more of the fasteners that secure the soffit can disengage. If this occurs, a fastener could fall into the patient compartment. In rare circumstances, if multiple fasteners disengage, the canopy soffit can become loose or detach. These conditions could potentially result in patient injury.
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- Serial Numbers: 5452896 801057486 800977619 801093759 5584569 5587625 5367527 5603110 5371240 5497382
- Quantity
- 265 units
- Distribution
- Worldwide - US Nationwide distribution.
- Recalling firm
- GE Medical Systems, LLC, Waukesha, WI
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-05-01
Source: openFDA enforcement record Z-2477-2026 · search recall number Z-2477-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.