BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-0282-2014 · Initiated September 30, 2013

    Recall

    Recall Number
    Z-0282-2014
    Event Number
    66537
    Firm
    Draeger Medical, Inc.
    FEI Number
    2517967
    Product Code
    FQO
    Status
    Terminated
    Root Cause
    Equipment maintenance
    Initiated
    September 30, 2013
    Posted
    November 14, 2013
    Terminated
    September 3, 2014
    Address
    3135 Quarry Rd, Telford, PA, 18969-1042

    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).

    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.

    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