BEUDAMED
    FDA Enforcement Class III 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 · Reported November 13, 2013

    Enforcement

    Recall Number
    Z-0155-2014
    Event ID
    66587
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Trumpf Medical Systems
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    November 13, 2013
    Initiation Date
    July 24, 2013
    Classification Date
    November 5, 2013
    Termination Date
    June 3, 2014
    Address
    1046 Legrand Blvd, N/A, Charleston, SC, 29492-7672, United States

    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.

    Code Info

    Item No. 1275499, Serial No. 100711351

    Distribution

    US Distribution: NJ only.

    Quantity

    One