BEUDAMED
    FDA Enforcement Class II Ongoing

    Brand Name: RayStation -Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 8.1.0.47, 8.1.1.8, 8.1.2.5, 9.0.0.113 and 9.0.1.142 Software Version: RayStation 8B, 8B Service Pack 1 and 2, 9A and 9A Service Pack 1

    Recall: Z-1186-2025 · Reported February 26, 2025

    Enforcement

    Recall Number
    Z-1186-2025
    Event ID
    96156
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    RAYSEARCH LABORATORIES AB
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    February 26, 2025
    Initiation Date
    January 16, 2025
    Classification Date
    February 19, 2025
    Address
    Eugeniavagen 18c, N/A, Stockholm, N/A, N/A, Sweden

    Description

    Brand Name: RayStation -Intended as a Radiation Therapy Treatment Planning System Model/Catalog Number: 8.1.0.47, 8.1.1.8, 8.1.2.5, 9.0.0.113 and 9.0.1.142 Software Version: RayStation 8B, 8B Service Pack 1 and 2, 9A and 9A Service Pack 1

    Reason

    Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, Robust evaluation and Compute perturbed dose for proton and light ion treatment plans when a HU-to-mass density CT calibration curve used in RayStation version 4.5 to 2024B including some service packs.

    Code Info

    Lot Code: UDI: 0735000201011220180608, 0735000201013620180928, 0735000201017420190612 and 0735000201048820220420 GTIN: 07350002010112, 07350002010136, 07350002010174 and 07350002010488 Serial Numbers: 8.0.0.61, 8.0.1.10, 9.0.0.113 and 9.0.1.142 Software Revisions: RayStation 8B, 8B Service Pack 1 and 2, 9A and 9A Service Pack 1 Expiration Date: 2027-12-15

    Distribution

    Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Belgium ENG, Canada, China, China APactron, Denmark, France, Germany, Hong Kong S.A.R. China, India, Italy, Japan, Korea, Netherlands, Norway, Poland, Singapore, Spain, SwitzerlandENG, Taiwan, Thailand, UK.

    Quantity

    1