Incubator, Infant, Stationary
Recall Summary Datex-Ohmeda Inc is recalling stationary infant incubators distributed to hospitals, pharmacies, and laboratories in New Zealand. The manufacturer is issuing guidance on how to use the devices properly. This is classified as a Class I recall, which indicates a serious situation.
- Recalling firm
- GE Healthcare Limited
- Product
- Incubator, infant, stationary. [Device]. 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
- Reason
- 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.
- Classification
- Class I
- Category
- medical device recall
- Country
- New Zealand
- Agency
- MEDSAFE
- Recall date
- 2026-06-08
- Status
- Ongoing
- Distribution
- New Zealand - Hospital/Pharmacy/Laboratory
Official recall notice from MEDSAFE
Recall details on Nibble Recalls: https://trynibble.app/recalls/23d73286-a49c-4d90-b30a-a15b1315d5c2