BEUDAMED
    FDA Recall Terminated

    RayStation standalone software radiation therapy treatment planning system. Model Number: 8A, 8B, 9A, 9B, 10A, 10B including some service packs

    Recall: Z-1598-2021 · Initiated April 7, 2021

    Recall

    Recall Number
    Z-1598-2021
    Event Number
    87868
    Firm
    RAYSEARCH LABORATORIES AB Sveavagen 9 Stockholm Sweden
    FEI Number
    3007774465
    Product Code
    MUJ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    April 7, 2021
    Terminated
    June 2, 2023

    Description

    RayStation standalone software radiation therapy treatment planning system. Model Number: 8A, 8B, 9A, 9B, 10A, 10B including some service packs

    Reason

    When using more than one plan in a treatment course, the Total dose display in Dose tracking may be incorrect. There may be a mismatch between the fractions that appear as selected in the Treatment course list in Dose tracking and the fractions that are included in the dose summation. The issue only affects RayTreat users and only the Total dose option. Accumulation and other options in Dose tracking are correct.

    Action

    On 04/08/2021, Gore issued an Urgent Medical Device Removal notice to customer via letter notifying them that a Gore Viabil Biliary Endoprosthesis 10 mm x 10 cm device appeared shorter than the labeled length.

    Distribution

    Domestic: TN