Recall Z-2475-2026 ยท FMZ Incubator, Neonatal
GE Medical Systems, LLC
Giraffe OmniBed, a combination of an infant incubator and an infant warmer, All Models
| Date | Jun 17, 2026 (initiated May 1, 2026) |
| Status | Open, Classified |
| 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. |
| Root cause | Component design/selection |
| Action | An URGENT MEDICAL DEVICE CORRECTION notification letter dated 5/1/26 was sent to customers. Actions to be taken by Customer/User You may continue to use your device after performing the pre-use checkout in accordance with the Giraffe OmniBed Carestation User Manual (Chapter 6 Pre-Use Checkout). During the pre-use checkout described in the product User Manual, visually inspect the device for any damaged or missing components. This includes verifying that the canopy soffit is properly secured and that all six fasteners are present and fully engaged. If you observe damage, missing fasteners, |
| Quantity | 19587 units |
| Distribution | Worldwide - US Nationwide distribution. |
| FDA record | Open on fda.gov |