BEUDAMED
    FDA Enforcement Class II Terminated

    Radiation Therapy Treatment Planning System, Model 5.0

    Recall: Z-0079-2017 · Reported October 19, 2016

    Enforcement

    Recall Number
    Z-0079-2017
    Event ID
    74750
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    RAYSEARCH LABORATORIES AB
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 19, 2016
    Initiation Date
    May 30, 2016
    Classification Date
    October 13, 2016
    Termination Date
    September 22, 2017
    Address
    Sveavaegen 9, N/A, Stockholm, N/A, N/A, Sweden

    Description

    Radiation Therapy Treatment Planning System, Model 5.0

    Reason

    For a treatment plan consisting of multiple beam sets, the table for ROI plan dose statistics in the report may show the statistics for a beam set dose. The error can only be triggered when using a report template where statistics for a beam set dose is included as the last dose statistics prior to the plan dose statistics.

    Code Info

    5.0.0.37, 5.0.1.11 and 5.0.2.35

    Distribution

    AZ, CA, FL, MT, NC NY, TX, OH & WA

    Quantity

    491 units (187 domestically & 304 internationally)