Recall Z-0539-2020 ยท FMT Warmer, Infant Radiant
GE Healthcare, LLC
Giraffe OmniBed Carestation, Model Numbers: 2082844-001-XXXXXX; Giraffe OmniBed Carestation CS1, Model Numbers: 2082844-001-XXXXXXXX. infant warmer
| Date | Dec 3, 2019 (initiated Oct 11, 2019) |
| Status | Terminated |
| Reason | Giraffe Incubator, Giraffe OmniBed, Giraffe Incubator Carestation, and Giraffe OmniBed Carestation Bedside panels and portholes can appear closed without being latched. Potential patient fall. |
| Root cause | Device Design |
| Action | The firm disseminated its notices by letter beginning on 10/11/2019. The notices identified the following safety issues: - The bedside panels of Giraffe Incubator, Giraffe OmniBed, Giraffe Incubator Carestation, and Giraffe OmniBed Carestation can be upright and look closed but not be latched. - The portholes also can look closed when not latched. - If a canopy cover is used, it can hold the bedside panel or porthole door closed without being latched. The product may continue to be used following specific safety instructions outlined in the notice. On/about 11/8/2019, the firm issued an |
| Quantity | 7814 units |
| Distribution | worldwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K152814 | Giraffe OmniBed Carestation CS1 Ohmeda Medical, A Division of Datex-Ohmeda,Inc. A GE Company, Mar 17, 2016 |