BEUDAMED
    FDA Enforcement Class II Terminated

    Ellex Medical Fixed eye Safety filters Model Integre S LP5532. The filter is located in the binocular mount of the laser delivery head. The filter prevents transmission of treatment laser light to physician eyes while the aiming beam to remain visible. .

    Recall: Z-1270-2016 · Reported April 13, 2016

    Enforcement

    Recall Number
    Z-1270-2016
    Event ID
    73468
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Laserex Systems Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 13, 2016
    Initiation Date
    February 1, 2016
    Classification Date
    April 7, 2016
    Termination Date
    October 27, 2016
    Address
    7138 SHADY OAK RD, N/A, EDEN PRAIRIE, MN, 55344-3517, United States

    Description

    Ellex Medical Fixed eye Safety filters Model Integre S LP5532. The filter is located in the binocular mount of the laser delivery head. The filter prevents transmission of treatment laser light to physician eyes while the aiming beam to remain visible. .

    Reason

    The Firm discovered that there is a design error which is traceable back to 2012 when a design change on the safety filter optic adaptor was implemented.

    Code Info

    Model Number : 3143270

    Distribution

    Worldwide Distribution - US Distribution

    Quantity

    72 units plus 2 spare units