BEUDAMED
    FDA Recall 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 · Initiated April 25, 2014

    Recall

    Recall Number
    Z-1806-2014
    Event Number
    68162
    Firm
    RAYSEARCH LABORATORIES AB Sveavaegen 9 Stockholm Sweden
    FEI Number
    3007774465
    Product Code
    MUJ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    April 25, 2014
    Posted
    June 17, 2014
    Terminated
    June 26, 2017

    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.

    Action

    On April 25, 2014, RaySearch emailed all consignees of the affected product a copy of the recall notice as well as the response forms. Back up notification methods include phone calls and site visits.

    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)