FDA Medical devices recall ·
Giraffe OmniBed Field Replaceable Unit (FRU)… recall
- Recall number
- Z-2477-2026
- Date
- (initiated May 1, 2026)
- Company / brand
- GE Medical Systems, LLC
3000 N Grandview Blvd, Waukesha, WI, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 265 units
- Hazard tags
- Fall Injury risk
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Giraffe OmniBed Field Replaceable Unit (FRU), Model Numbers 6600-1056-400 and 6600-1461-500
Why was it recalled?
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 should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Serial Numbers: 5452896 801057486 800977619 801093759 5584569 5587625 5367527 5603110 5371240 5497382
Distribution
Worldwide - US Nationwide distribution.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2477-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.