BEUDAMED
    FDA Recall Terminated

    Stationary Column TruSystem 7599, Material Number 1717020 Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recover from the anesthesia. Also, patient transport on the operating table top from a patient transfer system to the operating theater of from the operating theater to a patient transfer system.

    Recall: Z-0041-2017 · Initiated July 10, 2016

    Recall

    Recall Number
    Z-0041-2017
    Event Number
    75115
    Firm
    Trumpf Medical Systems, Inc.
    FEI Number
    3003184737
    Product Code
    JEA
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    July 10, 2016
    Posted
    October 5, 2016
    Terminated
    March 2, 2017
    Address
    1046 Legrand Blvd, Charleston, SC, 29492-7672

    Description

    Stationary Column TruSystem 7599, Material Number 1717020 Patient positioning during surgery, ranging from anesthesia induction to actual surgery to recover from the anesthesia. Also, patient transport on the operating table top from a patient transfer system to the operating theater of from the operating theater to a patient transfer system.

    Reason

    Three complaints describing TruSystem tables unexpectedly descending approximately 20 centimeters.

    Action

    Trumpf Medical sent an Urgent Field Safety Notice dated July 8, 2015, to all affected consignees. The letter indicated that the tables should not be used until an authorized service engineer has exchanged the spindles of the affected operating tables. The letter included an acknowledgement form which is to be returned. The letter also requested a sub-recall if the product had been further distributed. For questions regarding this recall call 843-329-0543.

    Distribution

    Worldwide Distribution - US including CA, CT, GA, IL, NC, OR, SC, VA, WI, WY, and Internationally to Australia, Azerbaijan, Brazil, Finland, France, Germany, Hungary, Italy, Luxembourg, Norway, Poland, Russia, Slovakia, and Switzerland

    Quantity

    84 units