BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-0526-2013 · Reported December 26, 2012

    Enforcement

    Recall Number
    Z-0526-2013
    Event ID
    63824
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    EEG Info
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 26, 2012
    Initiation Date
    November 15, 2012
    Classification Date
    December 17, 2012
    Termination Date
    June 11, 2013
    Address
    6400 Canoga Ave, Suite 210, Woodland Hills, CA, 91367-2425, United States

    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.

    Code Info

    Serial Number: 0001-3343.

    Distribution

    Nationwide Distribution

    Quantity

    1308 units