Ge Medical Systems, Llc: Incubator, Neonatal
Recall Summary GE HealthCare is recalling all models of the Giraffe OmniBed, a device that combines an infant incubator and warmer used in hospitals. Fasteners that hold the canopy cover in place can come loose or fall into the patient compartment during transport or impact, potentially injuring infants. The recall affects devices distributed nationwide across all U.S. states and territories.
- Recalling firm
- GE Medical Systems, LLC
- Product
- Giraffe OmniBed, a combination of an infant incubator and an infant warmer, All Models
- Reason
- 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.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-05-01
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Worldwide - US Nationwide distribution.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/a66930b3-8888-4765-8428-9340701ed026