BEUDAMED
    FDA Enforcement Class II Terminated

    Radiation Therapy Treatment Planning System software 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.

    Recall: Z-2785-2015 · Reported September 23, 2015

    Enforcement

    Recall Number
    Z-2785-2015
    Event ID
    71477
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    RAYSEARCH LABORATORIES AB
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    September 23, 2015
    Initiation Date
    May 29, 2015
    Classification Date
    September 17, 2015
    Termination Date
    March 13, 2017
    Address
    Sveavaegen 9, Stockholm, N/A, Sweden

    Description

    Radiation Therapy Treatment Planning System software 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.

    Reason

    An error caused by a floating point precision problem tends to cause a problem with the display of isodose lines for dose and dose difference and color tables for dose, dose difference and PET images

    Code Info

    software build numbers are 4.7.0.15 or 4.7.1.10

    Distribution

    Worldwide Distribution: US (nationwide) to state of WA; and countries of: France, Sweden, Austria, Spain, Germany, Italy, UK, New Zealand.

    Quantity

    20 devices