BEUDAMED
    FDA Recall Terminated

    ORBIT PT. The ORBIT PT works in conjunction with an TRUMPF mobile operating table to automate the patient transport process.

    Recall: Z-0155-2014 · Initiated July 24, 2013

    Recall

    Recall Number
    Z-0155-2014
    Event Number
    66587
    Firm
    Trumpf Medical Systems
    FEI Number
    3003184737
    Product Code
    JEA
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    July 24, 2013
    Posted
    November 5, 2013
    Terminated
    June 3, 2014
    Address
    1046 Legrand Blvd, Charleston, SC, 29492-7672

    Description

    ORBIT PT. The ORBIT PT works in conjunction with an TRUMPF mobile operating table to automate the patient transport process.

    Reason

    An odor and smoke developed - The cause was determined to be a power supply unit sitting in the controller column.

    Action

    The user facility was contacted via phone in early August. They were contacted 9/17/2013 to schedule the replacement of the power pack because the new power pack became available.

    Distribution

    US Distribution: NJ only.

    Quantity

    One