BEUDAMED
    FDA Enforcement Class II Ongoing

    RayStation/RayPlan. Model/Catalog Numbers: 11.0.0, 11.0.1, 11.0.3, 11.0.4. Software Version: RayStation 11A, RayStation 11A SP1, RayStation 11A SP2, RayStation 11A SP3. Radiation Therapy Treatment Planning System

    Recall: Z-1103-2026 · Reported January 28, 2026

    Enforcement

    Recall Number
    Z-1103-2026
    Event ID
    98117
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    RAYSEARCH LABORATORIES AB
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    January 28, 2026
    Initiation Date
    November 28, 2025
    Classification Date
    January 16, 2026
    Address
    Eugeniavagen 18c, Stockholm, N/A, Sweden

    Description

    RayStation/RayPlan. Model/Catalog Numbers: 11.0.0, 11.0.1, 11.0.3, 11.0.4. Software Version: RayStation 11A, RayStation 11A SP1, RayStation 11A SP2, RayStation 11A SP3. Radiation Therapy Treatment Planning System

    Reason

    Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs). This issue occurs for some ROI(s) which have no contours and either have a material override defined, or are of type Bolus, Fixation, or Support. In these cases, adding geometry to the ROI, subsequently modifying geometry, or removing the material override does not invalidate dose as intended.

    Code Info

    Lot Code: UDI: 0735000201038920210518, 0735000201043320210610, 0735000201044020210916, 35000201063120220616. GTIN: 07350002010389, 07350002010433, 07350002010440, 07350002010631. Serial Numbers: 11.0.0.951, 11.0.1.29, 11.0.3.116, 11.0.4.15. Software Revision: RayStation 11A, 11A SP1, 11A SP2, 11A SP3. Expiration Date: 2027-06-22.

    Distribution

    Refer to the attached documents: Distribution list 167168 US - updated, Distribution list 167168 OUS

    Quantity

    10 units