Servo Controlled Oxygen System for Ohmeda''s Medical Giraffe OmniBed and Ohmeda''s Medical Girraffe Incubators
FDA device recall Z-1064-03 · posted 2003-07-29 · Terminated
Recall details
- Recalling firm
- Ohmeda Medical, A division of Datex-Ohmeda, Inc.
- Reason for recall
- Firm's received complaints of medical device malfunction affecting instrument's calibration and alarm systems.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- 80FMZ
- Quantity affected
- 157 units
- Distribution
- Devices were sold to 15 international distributors and one domestic end user.
- Date initiated
- 2003-06-13
- Date posted
- 2003-07-29
- Date terminated
- 2003-07-29
- Location
- Laurel, MD
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| OHMEDA MEDICAL GIRAFFE OMNIBED (K020543) | Ohmeda Medical | 2002-05-09 |
| OHMEDA MEDICAL GIRAFFE INCUBATOR (K020547) | Ohmeda Medical | 2002-05-09 |