Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 36868 |
| Brand Name: | Incubator, infant, stationary |
| Model: | Giraffe OmniBeds - All models, Giraffe OmniBed Carestations - model 2082844-001-XXX, Field Replaceable Unit (FRU) - model 6600-1056-400 and 6600-1461-500 |
| Affected: | Canopy Soffits and fasteners on Giraffe OmniBed and Giraffe OmniBed Carestation Devices |
| Software version: | |
| Recalling Organisation: | GE Healthcare Limited Level 7, Vero Centre 48 Shortland St Auckland 1010 |
| Contact Information: | 0800 659 465 |
| Manufacturer: | Datex-Ohmeda Inc |
| Issue: | The manufacturer 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. |
| Recall action type: | Correction |
| Recall action: | Manufacturer to issue advice regarding use |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 8/6/2026 |
