GE Giraffe OmniBed Carestation recalled for loose fastener risk in infant incubator
GE Giraffe OmniBed Carestation recalled for fastener hazard
GE HealthCare identified a potential issue with fasteners that secure the canopy soffit on certain Giraffe OmniBed Carestations. During transport or impact, one or more fasteners can come loose and fall into the patient compartment. In rare cases, multiple fasteners may disengage, causing the canopy soffit to loosen or detach.
- Check your device serial number against the FDA notice to confirm if your unit is affected
- Contact GE HealthCare or your equipment vendor for inspection and corrective action
- Do not transport or move affected devices until fasteners have been checked and secured
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2476-2026More GE Medical Systems, LLC recalls
- FDA-Device2026-06-24GE Giraffe OmniBed infant bed recalled for detachable fastener hazard
- FDA-Device2026-06-24GE Giraffe OmniBed infant incubator recalled for loose fastener risk
- FDA-Device2026-06-17GE HealthCare Allia IGS 3 Pulse angiographic X-ray system recalled for electrical shock risk to service personnel
- FDA-Device2026-06-17GE Allia IGS Pulse X-ray system recalled for electrical shock risk to service personnel
- FDA-Device2026-06-17GE HealthCare Allia Moveo X-ray system recalled for electrical shock risk to service personnel
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