BEUDAMED
    FDA Enforcement Class II Terminated

    RayStation 4.7, version 4.7.1, used with Structure Definition or Automatic Breast Planning. Radiation Therapy Treatment Planning System, for treatment planning and analysis of radiation therapy.

    Recall: Z-2457-2015 · Reported September 2, 2015

    Enforcement

    Recall Number
    Z-2457-2015
    Event ID
    71414
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    RAYSEARCH LABORATORIES AB
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    September 2, 2015
    Initiation Date
    May 27, 2015
    Classification Date
    August 25, 2015
    Termination Date
    September 22, 2017
    Address
    Sveavaegen 9, N/A, Stockholm, N/A, N/A, Sweden

    Description

    RayStation 4.7, version 4.7.1, used with Structure Definition or Automatic Breast Planning. Radiation Therapy Treatment Planning System, for treatment planning and analysis of radiation therapy.

    Reason

    Issue with the algorithm for ROI contraction in RayStation 4.7 when non-uniform contraction distances are used. The ROI contraction tool uses six distances as input: right/left, inferior/superior and posterior/anterior. These contraction distances are, in error, pairwise reversed, i.e. right is interpreted as left, inferior is interpreted as superior, and posterior is interpreted as anterior.

    Code Info

    software build numbers are 4.7.1.10

    Distribution

    Distributed in CO, IL, MI, NC, OH,TN, and WA.

    Quantity

    126 programs