Recall Z-0282-2014 ยท FQO Table, Operating-Room, Ac-Powered
Draeger Medical, Inc.
Draeger Movita 603x/DVE 803x Ceiling Supply Unit. It is intended for use in operating theaters and intensive care
| Date | Nov 14, 2013 (initiated Sep 30, 2013) |
| Status | Terminated |
| Reason | Cases were encountered with the Draeger Movita 603x/DVE 803x Ceiling Supply Units where the drive screw in the motor unit broke and the lift arm fell down approximately 60 cm (23.6 inches). |
| Root cause | Equipment maintenance |
| Action | An "Urgent Medical Device Recall" notification letter was sent to users in September 2013. The issue was described and recommended actions were provided. Customers may contact (800) 543-5047 and select 1, then 2. |
| Quantity | 139 |
| Distribution | Worldwide distribution: US (Nationwide)and in the country of Canada. (note: the ceiling supply units are not classified as a medical device by Health Canada). |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.