GE Giraffe OmniBed infant incubator recalled for loose fastener risk
GE Giraffe OmniBed recalled for loose fastener risk
GE HealthCare identified a potential problem with fasteners that secure the canopy soffit (the cover beneath the control panel) on Giraffe OmniBed infant incubators and warmers. During transport or impact, one or more of these fasteners can come loose and fall into the patient compartment. In rare cases, multiple fasteners can disengage, causing the soffit to become loose or detach.
- Check if your serial number matches the recalled list on the FDA or GE HealthCare website.
- Contact GE HealthCare or your equipment supplier for inspection and repair instructions.
- Do not use the device if fasteners appear loose or the canopy soffit is damaged.
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-2475-2026More GE Medical Systems, LLC recalls
- FDA-Device2026-06-24GE Giraffe OmniBed infant bed recalled for detachable fastener hazard
- FDA-Device2026-06-24GE Giraffe OmniBed Carestation recalled for loose fastener risk in infant incubator
- 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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