BEUDAMED
    FDA Recall Terminated

    Motorised Safety Filter, Wild; Model number 6339590. Intended for photocoagulation.

    Recall: Z-0578-2010 · Initiated February 11, 2009

    Recall

    Recall Number
    Z-0578-2010
    Event Number
    54019
    Firm
    Ellex Medical Pty Ltd
    FEI Number
    3002806902
    Product Code
    HQF
    Status
    Terminated
    Root Cause
    Radiation Control for Health and Safety Act
    Initiated
    February 11, 2009
    Posted
    January 20, 2010
    Terminated
    September 7, 2012
    Address
    82 Gilbert Street, Adelaide, Australia

    Description

    Motorised Safety Filter, Wild; Model number 6339590. Intended for photocoagulation.

    Reason

    Potential for two screws important in the design of the safety filter to come loose.

    Action

    Ellex issued a bulletin stating the problem and identifying the affected products. Customers are to remove the Motorised Safety Filter from clinical use if the green laser light is visible while viewing through the microscope at any time during use of the Solitaire laser. The Bulletin also states that customers should contact an Ellex approved Service Engineer to investigate and perform the Field Corrective Action listed. The manufacturer will remedy the defect or bring the product into compliance free of charge. Ellex will inspect and rework all affected safety filters sold prior to February 2009.

    Distribution

    Worldwide Distribution.

    Quantity

    200 units total