BEUDAMED
    FDA Recall Terminated

    RayStation Radiation Therapy Treatment Planning System; -- RayStation 3.5, RayStation 4.0, RayStation 4.5 and RayStation 4.7. For RayStation 4.7, the issue applies also to machines with fixed jaws, regardless of MLC/jaw position. RayStation is a software system designed for treatment planning and analysis of radiation therapy.

    Recall: Z-1310-2015 · Initiated March 4, 2015

    Recall

    Recall Number
    Z-1310-2015
    Event Number
    70686
    Firm
    RAYSEARCH LABORATORIES AB Sveavaegen 9 Stockholm Sweden
    FEI Number
    3007774465
    Product Code
    MUJ
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    March 4, 2015
    Posted
    March 20, 2015
    Terminated
    September 20, 2017

    Description

    RayStation Radiation Therapy Treatment Planning System; -- RayStation 3.5, RayStation 4.0, RayStation 4.5 and RayStation 4.7. For RayStation 4.7, the issue applies also to machines with fixed jaws, regardless of MLC/jaw position. RayStation is a software system designed for treatment planning and analysis of radiation therapy.

    Reason

    An issue with photon dose calculation for DMLC (Dynamic MLC) plans for machines where the MLC is positioned above the jaws, e.g. some Elekta linacs. The magnitude of the error depends on the beam model output factor corrections and on the individual DMLC plan characteristics.

    Action

    The firm, Raysearch Laboratories, sent a "Medical Device Correction/Field Safety Notice" and Reply Form(dated 3/3/2015) on 3/4/2015 via e-mail to the affected customers. The notice describes the product, problem and actions to be taken. The customers were instructed to deprecate any beam models that have been commissioned as DMLC capable for the affected linac types; do not commission beam models as DMLC capable for the affected linac types; educate physics staff and all users; inspect your system and identify all affected units of RayStation, acknowledge this notice by email or complete and return the Reply Form via fax to Americas market, RaySearch Americas Inc., at 888 501 7195, email: [email protected] or Rest of the world, RaySearch Laboratories AB, to email [email protected]. If you have any questions, contact Quality and Regulatory Affairs Manager, at +46 722 366 110 or email [email protected].

    Distribution

    Nationwide Distribution.

    Quantity

    Domestic: 245 units