BEUDAMED
    FDA Recall Terminated

    Vision One Laser System Model GA-0025020, Serial No: 10050, 10051, 10053. Intended for use in the treatment of ocular pathology.

    Recall: Z-2191-2013 · Initiated August 19, 2013

    Recall

    Recall Number
    Z-2191-2013
    Event Number
    66133
    Firm
    Lumenis, Inc.
    FEI Number
    1720381
    Product Code
    GEX
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    August 19, 2013
    Posted
    September 11, 2013
    Terminated
    December 19, 2013
    Address
    3959 W 1820 S, Salt Lake City, UT, 84104

    Description

    Vision One Laser System Model GA-0025020, Serial No: 10050, 10051, 10053. Intended for use in the treatment of ocular pathology.

    Reason

    Lumenis has initiated a recall on certain models of Vision One System due to a potential for unintended laser exposure to the user.

    Action

    Customer's were notified via letter on 8/19/13. Service visits to consignees were scheduled with anticipated completion on 8/26/13 to replace the control board. Consignee monitoring was performed by use of return reply verification tracking cards returned by the Lumenis service engineer after completion of CPU board replacement.

    Distribution

    Distributed in the states of NJ, PA, and IL.

    Quantity

    3 units