BEUDAMED
    FDA Recall Terminated

    DermaStyle Chroma 2-blue and red light device indicated to be used in treating skin blemishes; portable home therapy; Lumiport LLC.

    Recall: Z-0156-2007 · Initiated September 28, 2006

    Recall

    Recall Number
    Z-0156-2007
    Event Number
    36406
    Firm
    Lumiport, LLC
    FEI Number
    3005952043
    Product Code
    MOQ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 28, 2006
    Posted
    November 7, 2006
    Terminated
    March 13, 2012
    Address
    5255 North Edgewood Drive, Suite 235, Provo, UT, 84604

    Description

    DermaStyle Chroma 2-blue and red light device indicated to be used in treating skin blemishes; portable home therapy; Lumiport LLC.

    Reason

    Incorrect charger; batteries may overheat , catch fire or explode while being charged with the charger enclosed with the device.

    Action

    Individual customers were contacted through e-mail and/or telephone beginning 09/28/2006. They were told to stop charging and using their current DermaStyle and to destroy it to prevent accidental usage. New replacements will be mailed to all customers.

    Distribution

    World wide Distribution-sales by direct mail or internet-USA and Canada

    Quantity

    2480 units