BEUDAMED
    FDA Enforcement Class II Terminated

    XLTEK EMU40EX EEG Headbox

    Recall: Z-2570-2018 · Reported August 8, 2018

    Enforcement

    Recall Number
    Z-2570-2018
    Event ID
    80239
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Natus Neurology DBA Excel Tech., Ltd. (XLTEK)
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 8, 2018
    Initiation Date
    May 15, 2018
    Classification Date
    July 28, 2018
    Termination Date
    May 6, 2024
    Address
    2568 Bristol Cir, N/A, Oakville, N/A, N/A, 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.

    Code Info

    Part Numbers: 10406, 002933

    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