BEUDAMED
    FDA Recall Terminated

    Ellex Solo LT5106-S ophthalmic laser (not sold in USA)

    Recall: Z-1844-2011 · Initiated February 15, 2011

    Recall

    Recall Number
    Z-1844-2011
    Event Number
    58076
    Firm
    Ellex Medical Pty Ltd
    FEI Number
    3002806902
    Product Code
    HQF
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    February 15, 2011
    Posted
    April 12, 2011
    Terminated
    October 2, 2012
    Address
    82 Gilbert Street, Adelaide, Australia

    Description

    Ellex Solo LT5106-S ophthalmic laser (not sold in USA)

    Reason

    Unintended laser emission while the user was moving the joystick for targeting.

    Action

    Ellex notified all distributors that have received the affected devices per Global Customer Service Bulletin GSB-11 -01a, dated 25 February 2011.

    Distribution

    worldwide distribution

    Quantity

    193 units