BEUDAMED
    FDA Recall Terminated

    RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6, RayPlan 1 (RayStation 4.9) and RayPlan 2 (RayStation 6) . Intended Use: software system designed for treatment planning and analysis of radiation therapy

    Recall: Z-1930-2019 · Initiated November 20, 2017

    Recall

    Recall Number
    Z-1930-2019
    Event Number
    83152
    Firm
    RAYSEARCH LABORATORIES AB Sveavagen 9 Stockholm Sweden
    FEI Number
    3007774465
    Product Code
    MUJ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    November 20, 2017
    Terminated
    August 8, 2023

    Description

    RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6, RayPlan 1 (RayStation 4.9) and RayPlan 2 (RayStation 6) . Intended Use: software system designed for treatment planning and analysis of radiation therapy

    Reason

    When calculating electron Monte Carlo dose with a very large number of histories, the dose calculation may be wrong

    Action

    RaySearch issued Field Safety Notice, Medical Device Correction #24138 via email on November 20th, 2017. The letter identifies the product, issue, health risk and action to take: Do not use a number of histories above 6 million for electron dose calculation. Inspect all commissioned electron beam models for any applicator calculated with greater than 6 million. Contact customer support if you have any further questions. Confirm you have read and understood this notice. This issue will be resolved in the next version of RayStation, scheduled for market release in December 2017. Educate planning staff and all users about this workaround.

    Distribution

    US Nationwide Distribution

    Quantity

    744