BEUDAMED
    FDA Recall Terminated

    Camera System, Television, Surgical without audio Intended for transmission and documentation of surgical interventions for the purpose of archiving and teaching.

    Recall: Z-0824-2018 · Initiated December 15, 2017

    Recall

    Recall Number
    Z-0824-2018
    Event Number
    79336
    Firm
    Trumpf Medical Systems, Inc.
    FEI Number
    3003184737
    Product Code
    FWB
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 15, 2017
    Terminated
    April 23, 2020
    Address
    1046 Legrand Blvd, Charleston, SC, 29492-7672

    Description

    Camera System, Television, Surgical without audio Intended for transmission and documentation of surgical interventions for the purpose of archiving and teaching.

    Reason

    The radiated emission from the TruVidia" Wireless Receiver is above the normative accepted limits, in which the radiated emission may interact with other devices in the operating room and cause them not to function properly.

    Action

    Trumpf Medical Systems sent an Urgent Medical Device Correction letter dated December 15, 2017. Instructions include to complete and return the Confirmation of Receipt, arrange for the Trumpf Medical Engineer or an authorized Service Engineer to upgrade the affected device, and ensure that all users of the device are aware of the recall. For further questions, please call (843) 329-0543

    Distribution

    Worldwide Distribution - US Distribution to the states of : GA, IL, IN, PA, SC, TX, UT, VA. and to the countries of : Austria, Australia, Bangladesh, Belgium, France, Switzerland, Czech Republic, Germany, Denmark, Spain, United Arab Emirates, United Kingdom, Ireland, Italy, Kuwait, Lithuania, Poland, Portugal, Romania, Sweden, Slovenia, Thailand, Turkey.

    Quantity

    212 devices