Ge Medical Systems, Llc: Incubator, Neonatal
Recall Summary GE HealthCare is recalling Giraffe OmniBed Carestations (Model 2082844-001-XXX), which are devices that combine an infant incubator and warmer used in hospitals. Fasteners securing the canopy soffit under the control panel can come loose or fall into the patient area during transport or impact, potentially injuring newborns. The recall affects devices distributed nationwide across all U.S. states and territories.
- Recalling firm
- GE Medical Systems, LLC
- Product
- Giraffe OmniBed Carestations and Giraffe OmniBed Carestation CS1, a combination of an infant incubator and an infant warmer, Model Numbers 2082844-001-XXX
- 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/c45b0034-45f0-45c6-946d-8682261e17c2