Draeger Movita 603x/DVE 803x Ceiling Supply Unit. It is intended for use in operating theaters and intensive care
FDA Recall Z-0282-2014 · Posted 2013-11-14
Recalling FirmDraeger Medical, Inc.
Recall StatusTerminated
Product CodeFQO
Date Initiated2013-09-30
Date Terminated2014-09-03
Product Quantity139
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).
Firm 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.
Root Cause
Equipment maintenance
Distribution Pattern
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).
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.