BEUDAMED
    FDA Recall Terminated

    EEG NeuroAmp, Model Number: CS 10090; CS 10137. Biofeedback and Relaxation

    Recall: Z-0526-2013 · Initiated November 15, 2012

    Recall

    Recall Number
    Z-0526-2013
    Event Number
    63824
    Firm
    EEG Info
    FEI Number
    3009138210
    Product Code
    HCC
    Status
    Terminated
    Root Cause
    Labeling False and Misleading
    Initiated
    November 15, 2012
    Posted
    December 17, 2012
    Terminated
    June 11, 2013
    Address
    6400 Canoga Ave, Suite 210, Woodland Hills, CA, 91367-2425

    Description

    EEG NeuroAmp, Model Number: CS 10090; CS 10137. Biofeedback and Relaxation

    Reason

    EEG Info, Inc. is recalling the EEG Neuroamp device because they have identified a potential risk associated with the mislabeling of certain devices.

    Action

    EEGInfo sent a recall notification letterdated November 29, 2012, to all affected customers. The letter informed the customers they have not received approval from the FDA to market and distribute a device for therapeutic applications other than that of its FDA intended use-biofeedback relaxation. Customers are informed that the safety and effectiveness for other indications has not been established. The risk or likelihood of serious adverse health consequences is remote. Customers were instructed to forward this notice if affected product was further distributed. Customers with questions about the notification letter are instructed to contact EEG Info's customer support line during normal business hours, Monday-Friday, from 8am-5pm PST. For questions regarding this recall call 818-456=5965.

    Distribution

    Nationwide Distribution

    Quantity

    1308 units