FDA-Device2026-06-24Class IIPROCESSING DEFECT

GE Giraffe OmniBed infant incubator recalled for loose fastener risk

OTHERNationwide distribution

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.
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
19587 units
Manufactured in
3000 N Grandview Blvd, Waukesha, WI, United States
Products
Giraffe OmniBed, a combination of an infant incubator and an infant warmer, All Models

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2475-2026

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