BEUDAMED
    FDA Recall 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 · Initiated October 9, 2014

    Recall

    Recall Number
    Z-0141-2015
    Event Number
    69426
    Firm
    Trumpf Medical Systems, Inc.
    FEI Number
    3003184737
    Product Code
    JEA
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    October 9, 2014
    Posted
    October 27, 2014
    Terminated
    March 23, 2016
    Address
    1046 Legrand Blvd, Charleston, SC, 29492-7672

    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.

    Action

    TRUMPF sent an Urgent Medical Device Correction letter dated October 3, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Actions to be taken: Complete and return the attached Confirmation of Receipt form with serial numbers of the TITAN table(s) and the serial number(s) for any remote controls you have. We will then arrange to send replacement remotes, which have been redesigned to eliminate this mode of failure. You will then be required to dispose of your recalled remotes. If you have any questions concerning this request or the procedure as outlined, please contact TRUMPF Medical Systems, Inc. at 888-474-9359.

    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