BEUDAMED
    FDA Recall Terminated

    VEST 6.6 or earlier software for use with Neuro Kinetics products. The device is used for vestibular testing.

    Recall: Z-2253-2009 · Initiated July 24, 2009

    Recall

    Recall Number
    Z-2253-2009
    Event Number
    52961
    Firm
    Neuro Kinetics
    FEI Number
    2519945
    Product Code
    LXV
    Status
    Terminated
    Root Cause
    PMA
    Initiated
    July 24, 2009
    Posted
    September 30, 2009
    Terminated
    January 13, 2010
    Address
    128 Gamma Dr, Pittsburgh, PA, 15238-2920

    Description

    VEST 6.6 or earlier software for use with Neuro Kinetics products. The device is used for vestibular testing.

    Reason

    Marketed without a 510k or PMA submission to include the normative data display.

    Action

    A notification letter was emailed to customers starting on August 10, 2009. The letter stated that the normative display needed to be removed pending FDA clearance. Direct questions to Neuro Kinetics, Inc. by calling 1-412-963-6649.

    Distribution

    Worldwide Distribution -- US (states of AL, AZ, CA, DC, FL, GA, HI, IN, MA, MD, MI, MN, NC, NY, OR, PA, SC, TN, UT, VA, WA, and WV), Korea, United Kingdom, and Spain.

    Quantity

    72 units