BEUDAMED
    FDA Recall 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 · Initiated November 21, 2013

    Recall

    Recall Number
    Z-0966-2014
    Event Number
    66995
    Firm
    Neuro Kinetics, Inc.
    FEI Number
    2519945
    Product Code
    GWN
    Status
    Terminated
    Root Cause
    No Marketing Application
    Initiated
    November 21, 2013
    Posted
    February 10, 2014
    Terminated
    July 20, 2015
    Address
    128 Gamma Dr, Pittsburgh, PA, 15238-2920

    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.

    Action

    A recall notification letter, dated November 2013, was sent to Users. A follow up letter regarding scheduling removal of the software is planned for December 2013.

    Distribution

    Distributed USA (nationwide) and the country of Canada.

    Quantity

    148