BEUDAMED
    FDA Recall Terminated

    LumiWave 1X4 Infrared Therapy Device, Catalog # LW1X4, BioCare Systems, Inc.

    Recall: Z-1419-06 · Initiated June 14, 2006

    Recall

    Recall Number
    Z-1419-06
    Event Number
    35780
    Firm
    Biocare Systems Inc.
    FEI Number
    3005510978
    Product Code
    ILY
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 14, 2006
    Posted
    August 24, 2006
    Terminated
    January 3, 2011
    Address
    9853 Paperflower Drive, Parker, CO, 80138

    Description

    LumiWave 1X4 Infrared Therapy Device, Catalog # LW1X4, BioCare Systems, Inc.

    Reason

    Electrical Safety Hazard-when pulling on the cord of the AC adapter, to remove it from an outlet, the prongs on the AC adapter, may detach from the unit, damaging it and exposing the user to an electrical safety hazard

    Action

    Consignees were notified by telephone beginning 06/08/2006, followed by a letter on 06/23/2006.

    Distribution

    Nationwide distribution --- including the states of CA, CO, IL, MA, MD, MI, NC, FL, PA, TX, UT, WA.

    Quantity

    175 units