BEUDAMED
    FDA Enforcement Class II Terminated

    Neurosign V4 Intraoperative Nerve monitor family of devices.

    Recall: Z-2884-2020 · Reported September 2, 2020

    Enforcement

    Recall Number
    Z-2884-2020
    Event ID
    85985
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    The Magstim Company Limited
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 2, 2020
    Initiation Date
    June 23, 2020
    Classification Date
    August 25, 2020
    Termination Date
    August 16, 2024
    Address
    Spring Gardens, N/A, Whitland, N/A, N/A, United Kingdom

    Description

    Neurosign V4 Intraoperative Nerve monitor family of devices.

    Reason

    Reports that manipulation of the cable which connects the pre-amplifier to the nerve monitor, and the cable which connects the pre-amplifier to the stimulator pod, may cause damage to the internal construction of the cables.

    Code Info

    Serial numbers # 001 to 049. US product serial number is 039.

    Distribution

    Domestic: MN International: UK, Republic of Ireland, Spain, Netherlands, Canada. (Technomed Europe distributed to: Brazil, Spain, Belgium, Chile, Greece, Poland, New Zealand, Pakistan, Portugal and Thailand.

    Quantity

    49 devices