BEUDAMED
    FDA Enforcement Class II Ongoing

    Nexstim eXima NBS System Software version 2.2 or higher. The Nexstim Navigated Brain Stimulation System (NBS System) is indicated for noninvasive mapping of the primary motor cortex of the brain to its cortical gyrus. The NBS System provides information that may be used in the assessment of the primary motor cortex for pre-procedural planning. The NBS System is not intended to be used during a surgical procedure. The NBS System is intended to be used by trained clinical professionals.

    Recall: Z-2319-2017 · Reported June 14, 2017

    Enforcement

    Recall Number
    Z-2319-2017
    Event ID
    77198
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Nexstim PLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 14, 2017
    Initiation Date
    March 14, 2017
    Classification Date
    June 8, 2017
    Address
    Elimaenkatu 9B, N/A, Helsinki, N/A, N/A, Finland

    Description

    Nexstim eXima NBS System Software version 2.2 or higher. The Nexstim Navigated Brain Stimulation System (NBS System) is indicated for noninvasive mapping of the primary motor cortex of the brain to its cortical gyrus. The NBS System provides information that may be used in the assessment of the primary motor cortex for pre-procedural planning. The NBS System is not intended to be used during a surgical procedure. The NBS System is intended to be used by trained clinical professionals.

    Reason

    Software defect: the NBS software may accidentally generate duplicate copies of one or several files.

    Code Info

    Serial numbers: NBS101, NBS106, NBS140, NBS141, NBS145, NBS148, NBS155, NBS159, NBS163, NBS164, NBS166. NBS158 has been scrapped.

    Distribution

    Worldwide Distribution - US to GA only, Foreign: Europe

    Quantity

    11 units.