BEUDAMED
    FDA Enforcement Class II Terminated

    The product affected by this notice is sold under the trade name TomoTherapy SharePlan 1.1. To determine if the version you are using is affected, bring up the About box in the SharePlan application and check if the build number reported there is 1.3.1.10. Intended use: t-RayAutoplan is a software that, based on the planned dose distribution from a TomoPlan treatment planning system, generates a family of individually optimized IMRT plans and presents their characteristics to the user in a GUI. Among the generated plans, the user selects and clinically approves a treatment plan and exports it electronically to DICOM, for subsequent treatment of the patient. The intended users of t-RayAutoplan shall be clinically qualified staff, such as medical physicists, medical doctors or dosimetrists

    Recall: Z-2378-2012 · Reported September 26, 2012

    Enforcement

    Recall Number
    Z-2378-2012
    Event ID
    63110
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    RAYSEARCH LABORATORIES AB
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 26, 2012
    Initiation Date
    May 30, 2011
    Classification Date
    September 14, 2012
    Termination Date
    November 16, 2012
    Address
    Sveavaegen 9, Stockholm, N/A, Sweden

    Description

    The product affected by this notice is sold under the trade name TomoTherapy SharePlan 1.1. To determine if the version you are using is affected, bring up the About box in the SharePlan application and check if the build number reported there is 1.3.1.10. Intended use: t-RayAutoplan is a software that, based on the planned dose distribution from a TomoPlan treatment planning system, generates a family of individually optimized IMRT plans and presents their characteristics to the user in a GUI. Among the generated plans, the user selects and clinically approves a treatment plan and exports it electronically to DICOM, for subsequent treatment of the patient. The intended users of t-RayAutoplan shall be clinically qualified staff, such as medical physicists, medical doctors or dosimetrists

    Reason

    This field notice concerns two behaviors of the SharePlan (Multiple Fraction Groups and Depth Offset) that may be unexpected and are not clearly described in the user manual. None of these behaviors have caused patient mistreatment or other incidents. However, the described user actions must be adhered to for best agreement between treatment plan evaluation and the clinical outcome of the delivere

    Code Info

    SharePlan 1.1, aka t-RayAutoplan version 1.2.1 (build number 1.3.1.10).

    Distribution

    Worldwide Distribution - USA including CA, KY, MI, NY, OK, and OR. Internationally to Canada, Belgium, United Kingdom, Australia, France, Germany, and Poland.

    Quantity

    15 units