BEUDAMED
    FDA Enforcement Class II Terminated

    TITAN Operating Room Table Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recovery from anesthesia. Patient transport on the operating tabletop, from the patient transfer system to the operating theatre or from the operating theatre to the patient transfer system.

    Recall: Z-0141-2015 · Reported November 5, 2014

    Enforcement

    Recall Number
    Z-0141-2015
    Event ID
    69426
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Trumpf Medical Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 5, 2014
    Initiation Date
    October 9, 2014
    Classification Date
    October 27, 2014
    Termination Date
    March 23, 2016
    Address
    1046 Legrand Blvd, N/A, Charleston, SC, 29492-7672, United States

    Description

    TITAN Operating Room Table Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recovery from anesthesia. Patient transport on the operating tabletop, from the patient transfer system to the operating theatre or from the operating theatre to the patient transfer system.

    Reason

    Unintended movement of the operating table during surgical cases due to the use of damaged TITAN remotes.

    Code Info

    TITAN Operating Tables: 1465166, 1228073, 1397903, 4544260.

    Distribution

    Worldwide Disttribution: US (nationwide) including the states of AL, AZ, CT, FL, GA, IA, IL, IN, KS, MD, MI, MN, MO, NC, ND, NJ, NM, NV, NY, OH, OR, PA, SC, TX, VA, WA and WY: and Internationally to Canada.

    Quantity

    184 units