BEUDAMED
    FDA Recall Terminated

    Digital Mobile X-ray Systems used to take diagnostic radiographic exposures or patients.

    Recall: Z-1064-2015 · Initiated September 22, 2014

    Recall

    Recall Number
    Z-1064-2015
    Event Number
    69388
    Firm
    Virtual Imaging, Inc.
    FEI Number
    3011066290
    Product Code
    IZL
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    September 22, 2014
    Posted
    February 9, 2015
    Terminated
    February 20, 2018
    Address
    5600 Broken Sound Blvd., Flr. 2nd, Boca Raton, FL, 33487

    Description

    Digital Mobile X-ray Systems used to take diagnostic radiographic exposures or patients.

    Reason

    There is a potential for unintended and erratic motion.

    Action

    Virtual Imaging sent an FIELD CORRECTION NOTIFICATION letter dated September 22, 2014, to all affected customers. The letters advised direct accounts that a Virtual Imaging Field Engineer with contact them to schedule an appointment for the replacement of the Digital Motion Control Kit. Customers with any concerns about this situation can contact Virtual Imaging's Technical Support at 561-893-8500 or via e-mail at [email protected].

    Distribution

    USA (nationwide) to the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, MT, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, WI, WV) + US Army facility in South Korea; and the country of Canada.

    Quantity

    316 (US) 6 (Foreign)