BEUDAMED
    FDA Recall Terminated

    QuantumPulse machine. Vibe Technologies, Greeley, CO. The device is used to create light wave frequencies to effect cellular activity.

    Recall: Z-0582-2009 · Initiated October 1, 2008

    Recall

    Recall Number
    Z-0582-2009
    Event Number
    49609
    Firm
    VIBE Technologies
    FEI Number
    3004494240
    Status
    Terminated
    Root Cause
    PMA
    Initiated
    October 1, 2008
    Posted
    January 14, 2009
    Terminated
    May 3, 2012
    Address
    2329 W 10th St, Greeley, CO, 80634-3527

    Description

    QuantumPulse machine. Vibe Technologies, Greeley, CO. The device is used to create light wave frequencies to effect cellular activity.

    Reason

    Medical device marketed without marketing approval for claims that include strengthening, recharging and removing toxins from cells.

    Action

    Customers were notified by letter on September 16, 2008 and were told to discontinue use as a medical device. This letter notification included: 1. A warning label to be placed on the Vibe machine stating that it is not a medical device and should not be used as such; 2. An updated operation manual/users guide containing no medical conditions or human body claims; and 3. A certification to be signed by the user and returned acknowledging receipt of the letter; affixed the warning label; will not promote the Quantum Pulse as a medical device; will remove any medical claims from their website; destroy any Quantum Pulse literature making medical claims and destroy any previous operation manual/user guides. Please contact VIBE Technologies at 800-356-9594 for questions or need assistance in complying with these actions.

    Distribution

    Worldwide Distribution.

    Quantity

    58