BEUDAMED
    FDA Enforcement Class II Ongoing

    BrainFeedback Pro 2 Device - is intended as an instrument that provides a visual and auditory signal corresponding to the status of a patients physiological parameters so that the patient can control voluntarily these physiological parameters.

    Recall: Z-2737-2024 · Reported September 4, 2024

    Enforcement

    Recall Number
    Z-2737-2024
    Event ID
    95089
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    RONAN MEDICAL LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    September 4, 2024
    Initiation Date
    December 11, 2023
    Classification Date
    August 27, 2024
    Address
    3225 International Cir Ste 100, Colorado Springs, CO, 80910-3161, United States

    Description

    BrainFeedback Pro 2 Device - is intended as an instrument that provides a visual and auditory signal corresponding to the status of a patients physiological parameters so that the patient can control voluntarily these physiological parameters.

    Reason

    Neurofeedback systems removed due to missing design and development documentation and devices may not perform as intended.

    Code Info

    UDI-DI: 08592566001017, 08592566001123, Serial Numbers: ACBFB12-1911003, ACBFB12-2004012, ACBFB12-2004014, ACBFB12-2105001, ACBFB12-2105002, ACBFB12-2105004, ACBFB12-2105005, ACBFB12-2109005, ACBFB12-2109006, ACBFB12-2109007, ACBFB12-2109008, ACBFB12-2301024

    Distribution

    Worldwide - US Nationwide distribution in the states of CA, FL, TN, MI, IL, CT and the countries of India.

    Quantity

    12