Recall Z-1064-03 ยท 80F
Ohmeda Medical, A division of Datex-Ohmeda, Inc.
Servo Controlled Oxygen System for Ohmeda''s Medical Giraffe OmniBed and Ohmeda''s Medical Girraffe Incubators
| Date | Jul 29, 2003 (initiated Jun 13, 2003) |
| Status | Terminated |
| Reason | Firm's received complaints of medical device malfunction affecting instrument's calibration and alarm systems. |
| Root cause | Other |
| Action | Recalling firm notified foreign distributors and domestic consignees by e-mail and phone on 6/13/2003. Foreign regional distributors were requested to manage the recall. The notification described various instrument problems and remedial action available via the firm''s field action retrofit kits, #6600-0126-850 for the Giraffe OmniBed and #6600-0261-850 for the Giraffe Incubator. |
| Quantity | 157 units |
| Distribution | Devices were sold to 15 international distributors and one domestic end user. |
| FDA record | Open on fda.gov |