Recall Z-2476-2026
- Recall number
- Z-2476-2026
- Event number
- 98986
- Firm
- GE Medical Systems, LLC
- Firm FEI
- 2126677
- Product code
- FMZ
- Status
- Open, Classified
- Initiated
- 2026-05-01
- Posted
- 2026-06-17
- Root cause
- Component design/selection
- 510(k) numbers
- K152814, K213551, K070291, K870223, K102226, K101778, K071977, K020547, K061856, K993407, K182859, K821896, K162821, K813239, K801461, K020543, K943360, K061280, K993051, K914864, K152809, K102710, K810067, K132543, K912000, K003067, K870222, K813238, K101788, K072512
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 for Recall#
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.