FDA Recall
Terminated
Servo Controlled Oxygen System for Ohmeda''s Medical Giraffe OmniBed and Ohmeda''s Medical Girraffe Incubators
Recall: Z-1064-03
·
Initiated June 13, 2003
Recall
- Recall Number
- Z-1064-03
- Event Number
- 26719
- Firm
- Ohmeda Medical, A division of Datex-Ohmeda, Inc.
- FEI Number
- 1121732
- Product Code
- 80FMZ
- Status
- Terminated
- Root Cause
- Other
- Initiated
- June 13, 2003
- Posted
- July 29, 2003
- Terminated
- July 29, 2003
- Address
- 8880 Gorman Road, Laurel, MD, 20723
Description
Servo Controlled Oxygen System for Ohmeda''s Medical Giraffe OmniBed and Ohmeda''s Medical Girraffe Incubators
Reason
Firm's received complaints of medical device malfunction affecting instrument's calibration and alarm systems.
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.
Distribution
Devices were sold to 15 international distributors and one domestic end user.
Quantity
157 units