BEUDAMED
    FDA Enforcement Class II Terminated

    MEE-1000A Neuromaster, Model No. Accessories: MS-110B (Electric Stimulation), MS-120BK (Current Stimulator Box) JB-116B, JB-132B (Amplifiers) Electromyography. (EMG)

    Recall: Z-0817-2016 · Reported February 24, 2016

    Enforcement

    Recall Number
    Z-0817-2016
    Event ID
    73114
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Nihon Kohden America Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 24, 2016
    Initiation Date
    January 19, 2012
    Classification Date
    February 17, 2016
    Termination Date
    February 22, 2016
    Address
    15353 Barranca Pkwy, Irvine, CA, 92618-2216, United States

    Description

    MEE-1000A Neuromaster, Model No. Accessories: MS-110B (Electric Stimulation), MS-120BK (Current Stimulator Box) JB-116B, JB-132B (Amplifiers) Electromyography. (EMG)

    Reason

    The MEE-1000A Neuromaster had defective printed circuit boards (PCBs). Gas arrestors on these boards which were intended to provide protection from electrostatic discharge failed to prohibit unintentional current flow.

    Code Info

    Serial Numbers: MS-110B: (17 units) 00013-00019, 00023- 00032 MS-120BK: (6 units) 0009- 00014 JB-116B: (31 units), 0008, 00012, 00014, 00016, 00018, 00019, 00020, 00021, 00023, 00025, 00026, 00027, 00028, 00029, 00031, 00032, 00034, 00035, 00039, 00043, 00102,00103, 00122-00128, 00134, 00135 JB-132B: (83 units) 00009, 00011, 00012, 00014, 00015, 00016, 00018, 00019, 00020, 00021, 00023, 00024, 00025, 00026, 00027, 00036, 00037, 00038, 00041, 00042, 00043, 00044, 00046, 00047, 00049, 00061, 00062, 00066, 00067, 00068, 00069,00071, 00072, 00074, 00075, 00082, 00084, 0085, 00086, 00090, 00095, 00099, 00120, 00121-00129, 00131-00147, 00149-00155, 00157, 00161, 00164-00168

    Distribution

    Worldwide distribution. US nationwide, Australia, Austria, France, Germany, Greece, Japan, Romania, South Africa, South Korea, Spain, and United Kingdom.

    Quantity

    477 units total (137 units in US)