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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 Recall
Draeger Movita 603x/DVE 803x Ceiling Supply Unit
see related information
Date Posted November 14, 2013
Recall Status1 Open
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, Pennsylvania 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
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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