BEUDAMED
    FDA Recall Terminated

    Best Theratronics cabinet x-ray systems intended for use in the irradiation of blood and blood products (packaged in transfusion bags) to inactivate T-lymphocytes for the prevention of Graft Versus Host Disease.

    Recall: Z-2251-2016 · Initiated May 6, 2016

    Recall

    Recall Number
    Z-2251-2016
    Event Number
    74637
    Firm
    BEST THERATRONICS LTD.
    FEI Number
    3006946288
    Product Code
    MOT
    Status
    Terminated
    Root Cause
    Radiation Control for Health and Safety Act
    Initiated
    May 6, 2016
    Posted
    July 22, 2016
    Terminated
    August 1, 2017
    Address
    413 MARCH ROAD, KANATA Canada

    Description

    Best Theratronics cabinet x-ray systems intended for use in the irradiation of blood and blood products (packaged in transfusion bags) to inactivate T-lymphocytes for the prevention of Graft Versus Host Disease.

    Reason

    It was discovered that both the new device and the predicate device failed to comply with performance standard.

    Action

    Best Theratronics ( BTL) planned action to bring into compliance: BTL proposes that the repairs are to be completed during annual routine preventive maintenance visits at the user's site to minimize downtime, which disrupts the user's ability to irradiate blood. A standard repair kit has been developed. For further information, please contact Best Theratronics Customer Service at 1-866-792-8598

    Distribution

    Nationwide

    Quantity

    128