FDA-Device2026-06-24Class IIPACKAGING DEFECT

GE Giraffe OmniBed infant bed recalled for detachable fastener hazard

OTHERNationwide distribution

GE Giraffe OmniBed recalled for loose fastener risk

GE HealthCare identified a potential issue with fasteners that secure the canopy soffit on certain Giraffe OmniBed infant beds. During transport or impact, one or more fasteners can come loose and fall into the patient compartment. In rare cases, multiple fasteners disengaging could cause the canopy soffit to loosen or detach entirely.

  • Check if your device is one of the affected serial numbers listed in the recall notice.
  • Contact GE HealthCare or your equipment supplier for instructions on fastener inspection or replacement.
  • Inspect the canopy soffit and fasteners before use, especially after transport.
  • Report any loose fasteners or canopy movement to GE HealthCare immediately.
Hazard

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.

Sold states
Worldwide - US Nationwide distribution.
Affected count
265 units
Manufactured in
3000 N Grandview Blvd, Waukesha, WI, United States
Products
Giraffe OmniBed Field Replaceable Unit (FRU), Model Numbers 6600-1056-400 and 6600-1461-500

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2477-2026

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