BEUDAMED
    FDA Recall Terminated

    Vantage Panoramic X-Ray System used to perform dental and orthodontic radiological imaging The Vantage Panoramic X-Ray System is a class II extra oral X-Ray system used to provide dental radiographic examination and diagnosis of diseases of the teeth, jaw and oral structures. When the system is equipped with the cephalometric option, the system will also provide cephalometric radiographic examinations for use in orthodontic treatment planning and evalu

    Recall: Z-0651-2016 · Initiated September 4, 2014

    Recall

    Recall Number
    Z-0651-2016
    Event Number
    70765
    Firm
    Midmark Corp dba Progeny Inc
    FEI Number
    3000210017
    Product Code
    MUH
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    September 4, 2014
    Terminated
    December 29, 2017
    Address
    675 Heathrow Dr, Lincolnshire, IL, 60069-4206

    Description

    Vantage Panoramic X-Ray System used to perform dental and orthodontic radiological imaging The Vantage Panoramic X-Ray System is a class II extra oral X-Ray system used to provide dental radiographic examination and diagnosis of diseases of the teeth, jaw and oral structures. When the system is equipped with the cephalometric option, the system will also provide cephalometric radiographic examinations for use in orthodontic treatment planning and evalu

    Reason

    Failure of the primary collimator may result in unintentional movement of the device. The unintentional movement will not result in the generation of an error message.

    Action

    MidMark sent an Urgent Medical Device Field Correction letter dated September 4, 2014, to all affected customers. The letter included instructions for distributors to: 1) encourage end users to contact Midmark to arrange the field correction after the final solution becomes available; 2) if a partial image is reported to have occurred with a machine, the machine should be removed from use and the end user should initiate a service request per the normal procedure; 3) quarantine any affected machines in the distributor's inventory and contact Midmark Technical Support within 10 business days to provide the Serial numbers to on-site servicing of the affected machines can be scheduled. Distributors with questions about this market action can contact Midmark Technical Support by calling 888-294-3800 x 3 or by e-mail at [email protected].

    Distribution

    Worldwide Distribution - US including AL, AR, AZ, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MI, MN, MO, MS, NE, NJ, NM, NV, NY, OH, OK, PA, SC, TN, TX, UT, VA, WA, WI; and Internationally to Australia, Belgium, Canada, Czech Republic, France, Hungary, Lithuania, New Zealand, Poland, Russia, Saudi Arabia, South Africa, Switzerland, Turkey, United Arab Emirates, United Kingdom, and Vietnam.

    Quantity

    832 systems