BEUDAMED
    FDA Enforcement Class II Terminated

    Monode, Shortwave Accessory Model #: 02200002 Used in conjunction with the Intelect Shortwave Diathermy 100 and Intelect Shortwave Diathermy 400 units. For the clinical application of electromagnetic energy in the radio frequency of 27.12 megahertz to generate deep heat within body tissues.

    Recall: Z-0121-2016 · Reported October 21, 2015

    Enforcement

    Recall Number
    Z-0121-2016
    Event ID
    72168
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    DJO, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 21, 2015
    Initiation Date
    August 21, 2015
    Classification Date
    October 14, 2015
    Termination Date
    October 24, 2016
    Address
    1430 Decision St, N/A, Vista, CA, 92081-8553, United States

    Description

    Monode, Shortwave Accessory Model #: 02200002 Used in conjunction with the Intelect Shortwave Diathermy 100 and Intelect Shortwave Diathermy 400 units. For the clinical application of electromagnetic energy in the radio frequency of 27.12 megahertz to generate deep heat within body tissues.

    Reason

    Overheating and burning of the wire insulation inside the applicator.

    Code Info

    Model #: 02200002 All units received from the manufacture prior to the week of July 12, 2015

    Distribution

    Worldwide Distribution - US Nationwide in the states of WY, OH, WA, NC, FL, NE, GA, KS CA, MO, IN, MA, IL, OK, AZ, TX, AR, UT, NJ, WI, PA, SC, WV, NY, MI, MN, VA, AK, TN, OR, NC, NH, KY, CO, NV, ID and the countries of El Salvador, China, Ecuador, South Korea, Chile, Israel, Peru, Nicaragua, Bolivia, Indonesia

    Quantity

    2887