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U.S. Department of Health and Human Services

Class 2 Device Recall Draeger Movita 603x/DVE 803x Ceiling Supply Unit

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  Class 2 Device Recall Draeger Movita 603x/DVE 803x Ceiling Supply Unit see related information
Date Initiated by Firm September 30, 2013
Date Posted November 14, 2013
Recall Status1 Terminated 3 on September 03, 2014
Recall Number Z-0282-2014
Recall Event ID 66537
Product Classification Table, operating-room, ac-powered - Product Code FQO
Product Draeger Movita 603x/DVE 803x Ceiling Supply Unit. It is intended for use in operating theaters and intensive care
Code Information Catalog numbers:MZ00614, MZ01038, MZ02190, MZ02254, and MZ02332
Recalling Firm/
Manufacturer		 Draeger Medical, Inc.
3135 Quarry Rd
Telford PA 18969-1042
For Additional Information Contact Customer Support
215-721-5400
Manufacturer 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).
FDA Determined
Cause 2		 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 in Commerce 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).
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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