Draeger Movita 603x/DVE 803x Ceiling Supply Unit. It is intended for use in operating theaters and intensive care
This recall has been terminated (originally issued November 14, 2013).
- Company
- Draeger Medical, Inc.
- Recall Initiated
- September 30, 2013
- Posted
- November 14, 2013
- Terminated
- September 3, 2014
- Recall Number
- Z-0282-2014
- Quantity
- 139
- Firm Location
- Telford, PA
- Official Source
- View on FDA website ↗
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).
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).
Lot / Code Info
Catalog numbers:MZ00614, MZ01038, MZ02190, MZ02254, and MZ02332
Root Cause
Equipment maintenance
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.
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