BEUDAMED
    FDA Enforcement Class II Terminated

    Varian brand Varian ARIA Oncology Information System, Import Export application, v 11.0; Reference/FSCA Identifier: CP-08847; Model Number: HIT; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA The ARIA Radiation Oncology product is a treatment plan and image management application. It enables the authorized user to enter, access, modify, store and archive treatment plan and image data from diagnostic studies, treatment planning, simulation, plan verification and treatment. ARIA Radiation Oncology also stores the treatment histories including dose delivered to defined sites and provides tools to verify performed treatments. ARIA also includes optional tools to manage the oncology department's clinical and business information.

    Recall: Z-2153-2012 · Reported August 15, 2012

    Enforcement

    Recall Number
    Z-2153-2012
    Event ID
    62562
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Varian Medical Systems, Inc. Oncology Systems
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 15, 2012
    Initiation Date
    July 2, 2012
    Classification Date
    August 7, 2012
    Termination Date
    July 1, 2013
    Address
    911 Hansen Way, Palo Alto, CA, 94304-1028, United States

    Description

    Varian brand Varian ARIA Oncology Information System, Import Export application, v 11.0; Reference/FSCA Identifier: CP-08847; Model Number: HIT; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA The ARIA Radiation Oncology product is a treatment plan and image management application. It enables the authorized user to enter, access, modify, store and archive treatment plan and image data from diagnostic studies, treatment planning, simulation, plan verification and treatment. ARIA Radiation Oncology also stores the treatment histories including dose delivered to defined sites and provides tools to verify performed treatments. ARIA also includes optional tools to manage the oncology department's clinical and business information.

    Reason

    A software anomaly has been identified with the Import Export Application version 11.0 where MLC leaf positions for plans using BrainLab m3 and mMLC are incorrectly imported.

    Code Info

    Serial Numbers/CODES: HIT0535, HIT2953

    Distribution

    Nationwide Distribution including the states of New York and Ohio.

    Quantity

    2 Units.