BEUDAMED
    FDA Recall Terminated

    Light Sheer Desire Diode Laser System with XC Handpiece Accessory options.

    Recall: Z-1519-2015 · Initiated March 25, 2015

    Recall

    Recall Number
    Z-1519-2015
    Event Number
    70863
    Firm
    Lumenis Limited 13 Hayetzira St., Yokneam Ind. Park Yokneam Israel
    FEI Number
    3004135191
    Product Code
    GEX
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    March 25, 2015
    Posted
    April 24, 2015
    Terminated
    June 15, 2016

    Description

    Light Sheer Desire Diode Laser System with XC Handpiece Accessory options.

    Reason

    Device software treatment preset parameters for the XC treatment handpiece do not match the Operator Manual, and exceed recommended settings. Operator Manual parameters are lower than indicated for specific hair color and Fitzpatrick skin type resulting in insufficient treatment effect. May result in patient burns and hypopigmentation.

    Action

    Lumenis Limited sent an Urgent Safety Advisory Notice dated March 25, 2015, to all affected customers. Customers were instructed that Lumenis is eliminating the potential risk of patient harm through a software upgrade and Operator Manual replacement. The software upgrade must be completed by a Lumenis-certified engineer as soon as possible. In the Interim, customers can continue to use their LightSheer DESIRE system by following the recommendations in the operator manual to always perform a test patch prior to a full treatment. Customers with questions were instructed to contact the Aesthetic Business Unit Product Manager. For questions regarding this recall call 801-656-2690.

    Distribution

    Worldwide distribution. US nationwide (to OR, NM, NY, IL, and CO), Switzerland, Canada, Italy, Great Britain, United Arab Emirates, France, Belgium, India, Israel, Japan, Portugal, Czech Republic, Kuwait, Germany, Spain, Georgia, Armenia, Slovenia, New Zealand, Saudi Arabia, and Russian Federation.

    Quantity

    117 units