BEUDAMED
    FDA Enforcement Class II Terminated

    RayStation 8B Service Pack 2, UDI # 07350002010235 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.

    Recall: Z-2348-2020 · Reported June 17, 2020

    Enforcement

    Recall Number
    Z-2348-2020
    Event ID
    85723
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    RAYSEARCH LABORATORIES AB
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    June 17, 2020
    Initiation Date
    May 18, 2020
    Classification Date
    June 10, 2020
    Termination Date
    August 6, 2021
    Address
    Sveavagen 9, N/A, Stockholm, N/A, N/A, Sweden

    Description

    RayStation 8B Service Pack 2, UDI # 07350002010235 - Product Usage: For radiation therapy and medical oncology which can also be used to administer treatments.

    Reason

    Software error was identified in the Pencil Beam Scanning (PBS) and Line Scanning (LS) dose calculation algorithms that could result in a local underestimation of expected dose.

    Code Info

    UDI # 07350002010235 Build number: 8.1.2.5

    Distribution

    US Nationwide distribution including in the states of Florida, Georgia, Utah, Virginia, California, Maryland, Arizona, Texas, Washington DC, Missouri, Massachusetts, Illinois, Oklahoma, New Jersey, Tennessee, and Louisiana.

    Quantity

    N/A