Draeger Movita 603x/DVE 803x Ceiling Supply Unit. It is intended for use in operating theaters and intensive care
FDA device recall Z-0282-2014 · posted 2013-11-14 · Terminated
Recall details
- Recalling firm
- Draeger Medical, Inc.
- Reason for recall
- 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).
- Action taken
- 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.
- Root cause
- Equipment maintenance
- Status
- Terminated
- Product code
- FQO
- Quantity affected
- 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).
- Date initiated
- 2013-09-30
- Date posted
- 2013-11-14
- Date terminated
- 2014-09-03
- Location
- Telford, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.