BEUDAMED
    FDA Enforcement Class II Terminated

    Normative Data Template CD for use with the I-Portal devices. Used to measure, record, or visually display the involuntary movements (nystagmus) of the eyeball.

    Recall: Z-0966-2014 · Reported February 19, 2014

    Enforcement

    Recall Number
    Z-0966-2014
    Event ID
    66995
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Neuro Kinetics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    February 19, 2014
    Initiation Date
    November 21, 2013
    Classification Date
    February 10, 2014
    Termination Date
    July 20, 2015
    Address
    128 Gamma Dr, N/A, Pittsburgh, PA, 15238-2920, United States

    Description

    Normative Data Template CD for use with the I-Portal devices. Used to measure, record, or visually display the involuntary movements (nystagmus) of the eyeball.

    Reason

    The data provided on the Normative Data Template CD for use with the I-Portal devices has not received clearance by FDA through the premarket 510(k) notification process.

    Code Info

    Software versions affected: 6.7.004, 6.8. 6.9, 6.10, 7.0, 7.0.1, and 7.1

    Distribution

    Distributed USA (nationwide) and the country of Canada.

    Quantity

    148