BEUDAMED
    FDA Enforcement Class II Completed

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

    Recall: Z-0942-2022 · Reported April 20, 2022

    Enforcement

    Recall Number
    Z-0942-2022
    Event ID
    89922
    Classification
    Class II
    Status
    Completed
    Product Type
    Devices
    Firm
    Varian Medical Systems Imaging Laboratory GmbH
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    N/A
    Report Date
    April 20, 2022
    Initiation Date
    March 21, 2022
    Classification Date
    April 14, 2022
    Address
    Tafernstrasse 7, DATTWIL, Baden, N/A, N/A, Switzerland

    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

    Code Info

    DI Numbers: 00856100006066, 00856100006080, 00856100006097, 00856100006110, 00856100006127,00856100006165

    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