Recall Z-2475-2026
- Recall number
- Z-2475-2026
- 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
- K020543, K101788, K070291, K870223, K102226, K101778, K071977, K020547, K061856, K993407, K182859, K821896, K162821, K813239, K801461, K943360, K061280, K993051, K914864, K152809, K102710, K810067, K132543, K912000, K003067, K870222, K813238, K072512, K913394, K974349
Product#
Giraffe OmniBed, a combination of an infant incubator and an infant warmer, All Models
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.