BEUDAMED
    FDA Enforcement Class II Terminated

    Draeger Movita 603x/DVE 803x Ceiling Supply Unit. It is intended for use in operating theaters and intensive care

    Recall: Z-0282-2014 · Reported November 20, 2013

    Enforcement

    Recall Number
    Z-0282-2014
    Event ID
    66537
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Draeger Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 20, 2013
    Initiation Date
    September 30, 2013
    Classification Date
    November 14, 2013
    Termination Date
    September 3, 2014
    Address
    3135 Quarry Rd, Telford, PA, 18969-1042, United States

    Description

    Draeger Movita 603x/DVE 803x Ceiling Supply Unit. It is intended for use in operating theaters and intensive care

    Reason

    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).

    Code Info

    Catalog numbers:MZ00614, MZ01038, MZ02190, MZ02254, and MZ02332

    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).

    Quantity

    139