BEUDAMED
    FDA Recall Completed

    ARIA Radiation Therapy Management (RTM) VERSIONS 13.6, 15.1, 15.5, 15.6, 16.0, 16.1

    Recall: Z-0942-2022 · Initiated March 21, 2022

    Recall

    Recall Number
    Z-0942-2022
    Event Number
    89922
    Firm
    Varian Medical Systems Imaging Laboratory GmbH Tafernstrasse 7 DATTWIL Baden Switzerland
    FEI Number
    3003094912
    Product Code
    IYE
    Status
    Completed
    Root Cause
    Software Design Change
    Initiated
    March 21, 2022

    Description

    ARIA Radiation Therapy Management (RTM) VERSIONS 13.6, 15.1, 15.5, 15.6, 16.0, 16.1

    Reason

    Software issue for treatment plan and image management application may result in mismatch values which could result in treatment in the wrong location

    Action

    On 3/21/22, Varian Medical Systems issued a "Urgent Medical Device Correction" notification to affected consignees. In addition to informing consignees about the recall, Varian asked consignees to take the following actions: Please retain a copy of this document along with your most current product labeling. Advise the appropriate personnel working in your radiotherapy department of the content of this letter. This document will be posted to the Varian Medical Systems customer support website: http://www.MyVarian.com. Please complete the attached Return Response form provided. Kindly return the completed form to [email protected].

    Distribution

    Worldwide distribution - US Nationwide distribution in the states of MI, KS, OH, VA, DC, FL, PA, OK, MN, AZ and the countries of South Korea, Netherlands, Poland, China.

    Quantity

    14