BEUDAMED
    FDA Recall 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 · Initiated July 21, 2015

    Recall

    Recall Number
    Z-2730-2015
    Event Number
    71832
    Firm
    Neuro Kinetics, Inc.
    FEI Number
    2519945
    Product Code
    GWN
    Status
    Terminated
    Root Cause
    No Marketing Application
    Initiated
    July 21, 2015
    Posted
    September 3, 2015
    Terminated
    September 27, 2016
    Address
    128 Gamma Dr, Pittsburgh, PA, 15238-2920

    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.

    Action

    Neuro Kinetics sent notification letters to end users on/about July 24, 2015, to alert them to the reason for recall and inform them of the corrective action planned by Neurokinetics. Action to be taken by you the Customer/User: If you have already initiated OVAR research (an IRB approved study with non-significant risk designation is ongoing), please reply to this email and include a copy of the IRB approval letter or the IRB approval information (e.g., investigators name, IRB name, IRB location, and study reference number). In return, NKI will mail you a field correction package with the necessary and appropriate Investigational Device labeling. If you have not initiated OVAR research (an IRB approved study is not ongoing), please discontinue use of the OVAR test and reply to this email to confirm that you are not using the OVAR test as part of an IRB approved study. In return, NKI will mail you a field correction package to disable the OVAR test functionality, which can be restored at the time you have an IRB approved study. Disabling the OVAR research test will have no effects on the functionality of the clinical tests included with your NOTC system. There will be no perceivable changes to the system outside of not being able to run the OVAR test. For questions regarding this recall call 412-963-6649.

    Distribution

    Worldwide Distribution - US (nationwide)

    Quantity

    45