BEUDAMED
    FDA Enforcement Class II Terminated

    RayStation software version 4.0.3.4 RayStation is a software system designed for treatment planning and analysis of radiation therapy.

    Recall: Z-1806-2014 · Reported June 25, 2014

    Enforcement

    Recall Number
    Z-1806-2014
    Event ID
    68162
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    RAYSEARCH LABORATORIES AB
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    June 25, 2014
    Initiation Date
    April 25, 2014
    Classification Date
    June 16, 2014
    Termination Date
    June 26, 2017
    Address
    Sveavaegen 9, N/A, Stockholm, N/A, N/A, Sweden

    Description

    RayStation software version 4.0.3.4 RayStation is a software system designed for treatment planning and analysis of radiation therapy.

    Reason

    This notice concerns a problem with the computation of ROI voxel volumes for cases where the CT has variable slice spacing. The dose grid volumetric representation of an ROI can be wrong. This affects all dose-volume properties for such ROIs, including DVH, dose statistics, clinical goals and constraints or objective functions. Furthermore, if material override ROIs are used, or if the external is not represented by contours, the bug can trigger an error in the 3D dose distribution.

    Code Info

    Software version 4.0.3.4

    Distribution

    Worldwide Distribution-USA (nationwide) including the states of AZ, CA, FL, IL, MA, MD, MO, MS, NJ, NV, NY, OH, PA, TN, VA, and WA, and the countries of Australia, Belgium, Germany, France, Italy, New Zealand, Republic of Korea, Switzerland, Spain, and United Kingdom.

    Quantity

    25 sites/245 units (US), 25 sites/124 units (foreign)