BEUDAMED
    FDA Enforcement Class II Terminated

    I-Portal¿ NOTC and VNG; a device used to measure, record, or visually display the involuntary movements (nystagmus) of the eyeball, indicated for use as a diagnostic tool to assist trained clinicians in their analysis of vestibular disorders, which requires the separation of central vs. peripheral nervous system deficits.

    Recall: Z-1795-2015 · Reported June 24, 2015

    Enforcement

    Recall Number
    Z-1795-2015
    Event ID
    71264
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Neuro Kinetics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 24, 2015
    Initiation Date
    April 30, 2015
    Classification Date
    June 12, 2015
    Termination Date
    April 17, 2017
    Address
    128 Gamma Dr, Pittsburgh, PA, 15238-2920, United States

    Description

    I-Portal¿ NOTC and VNG; a device used to measure, record, or visually display the involuntary movements (nystagmus) of the eyeball, indicated for use as a diagnostic tool to assist trained clinicians in their analysis of vestibular disorders, which requires the separation of central vs. peripheral nervous system deficits.

    Reason

    complaints of system malfunction and unintended, sudden movement at start up. No injuries reported.

    Code Info

    Model Numbers NOTC-S, NOTC-P, NOTC-C, NOTC-O, SVNG-1, SVNG-2, SVNG-3

    Distribution

    Worldwide distribution - US (nationwide) and Internationally to Canada and Mexico.

    Quantity

    140