BEUDAMED
    FDA Recall Terminated

    Draeger Globe Trotter IC, Catalog Number: MU20509, Draeger Medical, Inc., Telford, PA 18969

    Recall: Z-1053-2008 · Initiated January 31, 2008

    Recall

    Recall Number
    Z-1053-2008
    Event Number
    46742
    Firm
    Draeger Medical, Inc.
    FEI Number
    2517967
    Product Code
    FMZ
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    January 31, 2008
    Posted
    March 18, 2008
    Terminated
    May 8, 2008
    Address
    3135 Quarry Rd, Telford, PA, 18969-1042

    Description

    Draeger Globe Trotter IC, Catalog Number: MU20509, Draeger Medical, Inc., Telford, PA 18969

    Reason

    Heating failure- The power board which controls the incubator heater may not regulate the temperature properly resulting in a high temperature alarm and a loss of temperature control within the patient compartment.

    Action

    The firm notified consignees on 2/1/08, by an Important Safety Notice. The letter instructed users to remove any units from use until a Draeger Service Representative can replace the power board. A Service Representative will be in contact to schedule a service visit. For questions concerning this recall please contact 215-660-2418 or [email protected].

    Distribution

    Worldwide Distribution-- USA including states MO, OH, and PR, and countries of Australia, Canada, Columbia, Israel, UAE, France, China, Italy, Denmark, Switzerland, and UK.

    Quantity

    4 units