BEUDAMED
    FDA Enforcement Class II Terminated

    Ray Station Radiation Therapy Treatment Planning System, Model Numbers 3.0, 3.5 and 4.0

    Recall: Z-0281-2014 · Reported November 20, 2013

    Enforcement

    Recall Number
    Z-0281-2014
    Event ID
    66600
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    RAYSEARCH LABORATORIES AB
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    November 20, 2013
    Initiation Date
    October 23, 2013
    Classification Date
    November 14, 2013
    Termination Date
    February 17, 2017
    Address
    Sveavaegen 9, Stockholm, N/A, Sweden

    Description

    Ray Station Radiation Therapy Treatment Planning System, Model Numbers 3.0, 3.5 and 4.0

    Reason

    Ray Search Laboratories found an issue with the dose calculation for Elekta motorized wedges in Ray Station 3.0, 3.5 and 4.0. The error presents when a wedge is used for a beam and the wedge angle differs from 60 degrees.

    Code Info

    Software version and build numbers 3.0.0.251, 3.5.0.16, 3.5.1.6, 4.0.0.14, 4.0.1.4.

    Distribution

    US Distribution in the states of: California, Colorado, Delaware, Florida, Maryland, Missouri, New Jersey, New York, Ohio, Pennsylvania, Tennessee, and Virginia.

    Quantity

    195 units domestically