Ge Medical Systems, Llc: Incubator, Neonatal
Recall Summary GE HealthCare is recalling certain Giraffe OmniBed neonatal incubators (Model Numbers 6600-1056-400 and 6600-1461-500) because fasteners securing the canopy soffit under the control panel can loosen or come off during transport or impact, potentially falling into the patient compartment or causing the canopy to detach. The devices are distributed nationwide across the United States. This could potentially result in patient injury.
- Recalling firm
- GE Medical Systems, LLC
- Product
- Giraffe OmniBed Field Replaceable Unit (FRU), Model Numbers 6600-1056-400 and 6600-1461-500
- 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/558302ab-40d3-4496-a940-38ba593d8553