FDAMay 1, 2026device

Giraffe OmniBed, a combination of an infant incubator and an infant warmer, All Models

Official recall recorded by the U.S. Food & Drug Administration.

The 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.

What to do

FDA enforcement status: Ongoing

Brands named

ge medical systems

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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