BEUDAMED
    FDA Recall Terminated

    Lumenis M22 System Model Number: GA-0005400 (M22 IPL + YAG Module) with Acne Filter (KT-1014971).

    Recall: Z-1669-2016 · Initiated November 17, 2015

    Recall

    Recall Number
    Z-1669-2016
    Event Number
    73765
    Firm
    Lumenis Ltd 13 Hayetzira St.,Yokneam Ind. Park Yokneam Israel
    FEI Number
    3004135191
    Product Code
    GEX
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    November 17, 2015
    Posted
    May 13, 2016
    Terminated
    November 30, 2016

    Description

    Lumenis M22 System Model Number: GA-0005400 (M22 IPL + YAG Module) with Acne Filter (KT-1014971).

    Reason

    Lumenis Ltd Announces a Field Action of the M22 IPL Acne Filters for the Lumenis M22 IPL Hand Piece due to the Risk of Superficial Burns When Using the Device.

    Action

    Customers were notified on November 17, 2015 by Customer Notification Letter and customers were asked to return the device.

    Distribution

    Distributed in the states of GA, CA, CO, CT, KY, LA, MA, MN, NJ, NY, RI, and SC, and the countries of Italy, Germany, France, and China.

    Quantity

    33 filters