BEUDAMED
    FDA Enforcement Class II Terminated

    Neurosign 100, Product Number 9883-01. Intraoperative Nerve Monitor - Product Usage: indicated for use in stimulating and monitoring cranial motor nerves, especially the facial nerve (VII), during ENT surgical procedures.

    Recall: Z-0869-2021 · Reported January 27, 2021

    Enforcement

    Recall Number
    Z-0869-2021
    Event ID
    87063
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    The Magstim Company Limited
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    January 27, 2021
    Initiation Date
    December 8, 2020
    Classification Date
    January 15, 2021
    Termination Date
    February 16, 2023
    Address
    Spring Gardens, N/A, Whitland, N/A, N/A, United Kingdom

    Description

    Neurosign 100, Product Number 9883-01. Intraoperative Nerve Monitor - Product Usage: indicated for use in stimulating and monitoring cranial motor nerves, especially the facial nerve (VII), during ENT surgical procedures.

    Reason

    A small number of Neurosign 100 Intraoperative Nerve Monitors may have been dispatched without being configured appropriately for the supply mains within the target Country. The specific deficiency includes: 1. Onboard voltage selector set to 240V (European Standard), versus 120V requirement for the United States and Canada. 2. Fuses installed in the Power Entry Module (PEM) 2xT315mAL (240V Standard), versus the 2xT630mAL requirement for a 120V mains supply.

    Code Info

    Serial Numbers: 2507, 2511, 2514, 2515, 2522, 2527, 2533, 2534, 2537

    Distribution

    MN, NC, and NY

    Quantity

    7 units