Recall Z-1047-05 ยท FMZ Incubator, Neonatal
Ohmeda Medical, A division of Datex-Ohmeda, Inc.
Ohmeda Medical''s Giraffe OmniBeds and Giraffe Incubators
| Date | Jul 28, 2005 (initiated Apr 25, 2005) |
| Status | Terminated |
| Reason | Neonatal incubators and beds may unintentionally move from a safe position following an interruption in the power supply. |
| Root cause | Other |
| Action | Ohmeda Medical notified consignees 04/25/05 by letter flagged as an 'Urgent Medical Device Correction'. The serial number specific notification advised that the elevating base may move following the mains power interruption. The letter further advised that the notice should not be confused with a previous (medical device correction) letter sent concerning movement of the elevating base caused by the footswitches on the device. Ohmeda indicated in the letter that users may continue to use the device with stated precautions, pending hardware upgrade by the firm''s service technologists. |
| Quantity | 1674 devices |
| Distribution | The incubators were distributed to hospital neonatal intensive care centers across the US. The devices were additionally distributed to international subsidiaries and distributors. |
| FDA record | Open on fda.gov |