BEUDAMED
    FDA Recall Terminated

    MPI Rapid Response HUT Table, Model #RRHUT 1217 with Dual 2 Way Drop Section. The firm name on the label is Medical Positioning Inc., Kansas City, MO. Designed for multiple uses including a conventional examination table, unexplained syncope, neurocardiogenic syncope, chronic fatigue syndrome, and most noninvasive procedures. With the optional drop section, the use expands to echo/stress echo/Doppler studies, and vascular and carotid echo.

    Recall: Z-1210-2012 · Initiated March 5, 2012

    Recall

    Recall Number
    Z-1210-2012
    Event Number
    61348
    Firm
    Medical Positioning Inc
    FEI Number
    1000118382
    Product Code
    LGX
    Status
    Terminated
    Root Cause
    Error in labeling
    Initiated
    March 5, 2012
    Posted
    March 15, 2012
    Terminated
    July 11, 2013
    Address
    1717 Washington St, Kansas City, MO, 64108-1121

    Description

    MPI Rapid Response HUT Table, Model #RRHUT 1217 with Dual 2 Way Drop Section. The firm name on the label is Medical Positioning Inc., Kansas City, MO. Designed for multiple uses including a conventional examination table, unexplained syncope, neurocardiogenic syncope, chronic fatigue syndrome, and most noninvasive procedures. With the optional drop section, the use expands to echo/stress echo/Doppler studies, and vascular and carotid echo.

    Reason

    The warning label regarding electrical shock was not placed on the device warning to have the power switch in the "OFF" position prior to connecting the unit to electric power.

    Action

    Medical Positioning Inc. sent a "RAPID RESPONSE HUT TABLE LABELING CORRECTION NOTIFICATION" letter dated March 5, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter included an Owner's Manual insert page which clearly states the warning and how to avoid the electric shock hazard and a warning tag to attach to the product's power cord near the plug end using the provided wire tie. Contact the firm at 816-595-2356 for questions regarding this notice.

    Distribution

    Worldwide Distribution-USA (nationwide) including the states of IN, KS, WI, NY, IL, NC, OH, and MS and the country of Thailand.

    Quantity

    4 tables