BEUDAMED
    FDA Enforcement Class II Terminated

    Neuro Kinetics, Inc. (NKI) I-Portal¿ NOTC system with the OVAR research test; a rotary chair system used in vestibular and neuro-otologic diagnostic testing. This device provides no diagnoses nor does it provide diagnostic recommendations.The OVAR test has not yet been cleared by the FDA, and until then can only be used as an investigational device.

    Recall: Z-2730-2015 · Reported September 9, 2015

    Enforcement

    Recall Number
    Z-2730-2015
    Event ID
    71832
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Neuro Kinetics, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 9, 2015
    Initiation Date
    July 21, 2015
    Classification Date
    September 3, 2015
    Termination Date
    September 27, 2016
    Address
    128 Gamma Dr, N/A, Pittsburgh, PA, 15238-2920, United States

    Description

    Neuro Kinetics, Inc. (NKI) I-Portal¿ NOTC system with the OVAR research test; a rotary chair system used in vestibular and neuro-otologic diagnostic testing. This device provides no diagnoses nor does it provide diagnostic recommendations.The OVAR test has not yet been cleared by the FDA, and until then can only be used as an investigational device.

    Reason

    The devices that included the OVAR research test were not cleared for marketing and mTBI research package was sold with the incorrect investigational label.

    Code Info

    models: I-Portal¿ NOTC-O I-Portal¿ NOTC-C, with S/N 890739 S/N 900140 S/N 900133 S/N 900114 S/N 900172 S/N 900136 S/N 900162 S/N 900134 S/N 900137 S/N 900147 S/N 890739 S/N 900140 S/N 900169 S/N 890738 S/N 900133 S/N 900118 S/N 900127 S/N 900138 S/N 900163 S/N 890742 S/N 890773 S/N 900155 S/N 900150 S/N 900158 S/N 900125 S/N 900123 S/N 900108 S/N 900114 S/N 900160 S/N 900168 S/N 900102 S/N 900130 S/N 900131 S/N 900128 S/N 900144 S/N 890741 S/N 890726 S/N 890736 S/N 900145 S/N 900111 S/N 900119

    Distribution

    Worldwide Distribution - US (nationwide)

    Quantity

    45