BEUDAMED
    FDA Enforcement Class II Terminated

    RaySearch RayStation 2.5, 3.0, 3.5 and 4.0; Radiation Therapy Treatment Product Usage: RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user. The system functionality can be configured based on user needs. The intended users of RayStation shall be clinically qualified radiation therapy staff trained in using the system.

    Recall: Z-1679-2015 · Reported June 3, 2015

    Enforcement

    Recall Number
    Z-1679-2015
    Event ID
    71289
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    RAYSEARCH LABORATORIES AB
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    June 3, 2015
    Initiation Date
    May 8, 2015
    Classification Date
    May 27, 2015
    Termination Date
    April 11, 2017
    Address
    Sveavaegen 9, Stockholm, N/A, Sweden

    Description

    RaySearch RayStation 2.5, 3.0, 3.5 and 4.0; Radiation Therapy Treatment Product Usage: RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user. The system functionality can be configured based on user needs. The intended users of RayStation shall be clinically qualified radiation therapy staff trained in using the system.

    Reason

    RaySearch Laboratories AB became aware of an issue with the dose calculation for some imported VMAT plans where controls points are defined with wide gantry angle spacing.

    Code Info

    Software Version (Build numbers) 2.5.1.89, 3.0.0.251, 3.5.0.16, 3.5.1.6, 4.0.0.14, 4.0.1.4, 4.0.2.9, or 4.0.3.4

    Distribution

    US Nationwide Distribution

    Quantity

    Domestic: 539 units