BEUDAMED
    FDA Recall Terminated

    XTRAC Excimer Laser, Model No. AL8000, AL10000 The intended use is targeted UVB phototherapy for treatment of the skin conditions including psoriasis, vitiligo, atopic dermatitis, and leukoderma.

    Recall: Z-1455-2017 · Initiated January 23, 2017

    Recall

    Recall Number
    Z-1455-2017
    Event Number
    76697
    Firm
    Strata Skin Sciences, Inc.
    FEI Number
    3002942014
    Product Code
    GEX
    Status
    Terminated
    Root Cause
    Radiation Control for Health and Safety Act
    Initiated
    January 23, 2017
    Posted
    March 27, 2017
    Terminated
    June 5, 2017
    Address
    2375 Camino Vida Roble, Ste B, Carlsbad, CA, 92011-1556

    Description

    XTRAC Excimer Laser, Model No. AL8000, AL10000 The intended use is targeted UVB phototherapy for treatment of the skin conditions including psoriasis, vitiligo, atopic dermatitis, and leukoderma.

    Reason

    When the Liquid Guide ( LLG) is not used according to the operator manual, the switch control wires may become loose and shorted. Shorted wires may lead to unintentional laser firing.

    Action

    STRATA Skin Sciences, Inc., planned action to bring defect into compliance: The Center for Devices and Radiological Health (CDRH) understands that the CAP involving 1000 domestic units and 612 international units will consist of the following: 1. Send Field Correction notification to all consignees by January 30, 2017, 2. Verify all consignees received the notification by February 10, 2017, 3. Ship all Rear Panel Boards to consignees by May 1, 2017, and 4. All corrective actions will be performed at no cost to the purchasers For further questions call Customer service phone no.: (877) 449-8722

    Distribution

    USA (nationwide) Distribution

    Quantity

    US - 1000 , Foreign - 612