BEUDAMED
    FDA Recall Terminated

    XLTEK EMU40EX EEG Headbox

    Recall: Z-2570-2018 · Initiated May 15, 2018

    Recall

    Recall Number
    Z-2570-2018
    Event Number
    80239
    Firm
    Natus Neurology DBA Excel Tech., Ltd. (XLTEK)
    FEI Number
    3002809369
    Product Code
    GWQ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 15, 2018
    Terminated
    May 6, 2024
    Address
    2568 Bristol Cir, Oakville Canada

    Description

    XLTEK EMU40EX EEG Headbox

    Reason

    Possible degradation of an internal electronic component over time which may cause the XLTEK EMU 40EX Breakout box to fail. It may feel hot and plastic case may start melting.

    Action

    Natus Neurology notified customers on or about 05/15/2018, via Advisory Notification Letter to stop using the device immediately and contact Natus regarding replacement options. Customers were advised that if the malfunction occurs, to immediately cease using the device and contact Natus for replacement. Customers were also instructed to communicate the notification to all applicable users and to complete and return the advisory verification form.

    Distribution

    USA Distribution: AL, CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI MN, MO, NC, NE, NJ, NV, NY, OH, OR, PA, ,RI, SC, TN, TX, UT, VA, WA, WI. World wide Distribution: Canada, China, Cyprus, Germany, Hong Kong, Italy, Mexico, Saudi Arabia, Spain, United Kingdom

    Quantity

    462 Units Total