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U.S. Department of Health and Human Services

Enforcement Report - Week of November 20, 2013

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Product Detail

Product Description Draeger Movita 603x/DVE 803x Ceiling Supply Unit. It is intended for use in operating theaters and intensive care
Recall Number Z-0282-2014
Classification Class II
Code Info Catalog numbers:MZ00614, MZ01038, MZ02190, MZ02254, and MZ02332
Product Distributed Qty 139
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).

Event Detail

Event Id 66537
Product Type Devices
Status Ongoing
Recalling Firm Draeger Medical, Inc.
City Telford
State PA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-09-30
Initial Firm Notification of Consignee or Public Letter
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).