BEUDAMED
    FDA Enforcement Class II Terminated

    ARIA Radiation Oncology, versions 10, 11 , 13.0 and 13.5 with Clinical Assessment License. Model number HIT Product Usage: ARIA Radiation Oncology is a radiation treatment plan and image management application.

    Recall: Z-0170-2016 · Reported November 4, 2015

    Enforcement

    Recall Number
    Z-0170-2016
    Event ID
    72374
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Varian Medical Systems, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 4, 2015
    Initiation Date
    September 28, 2015
    Classification Date
    October 27, 2015
    Termination Date
    May 12, 2017
    Address
    911 Hansen Way, N/A, Palo Alto, CA, 94304-1028, United States

    Description

    ARIA Radiation Oncology, versions 10, 11 , 13.0 and 13.5 with Clinical Assessment License. Model number HIT Product Usage: ARIA Radiation Oncology is a radiation treatment plan and image management application.

    Reason

    An anomaly was identified with the ARIA for Radiation Oncology software with a Clinical Assessment license. Admin Instructions may not print on drug order prescriptions or be transmitted with e-Rx.

    Code Info

    Model number HIT: All units with software version 10, 11, 13.0 and 13.5 with Clinical Assessment license.

    Distribution

    Worldwide Distribution - US Nationwide and the countries of: Canada, Switzerland, South Korea, Germany, Spain, Ireland, Spain, France, Belgium, United Arab Emirates, United Kingdom, Norway, Italy, Trinidad and Tobago, Netherlands, Philippines, Portugal, Denmark, Sweden, Belgium, Saudi Arabia, Thailand, Australia, India, Taiwan, South Africa, Israel, Australia, Kuwait, Finland, Tunisia, Algeria, Argentina, Bangladesh, Brazil, Chile, China, Colombia, Costa Rica, Czech Republic, Guam, Guatemala, Hong Kong, Indonesia, Japan, Kazakhstan, Kuwait, Lebanon, Luxembourg, Madagascar, Moldova, Morocco, New Zealand, Panama, Poland, Qatar, Romania, Russia, Singapore, South Africa, Tunisia and Turkey.

    Quantity

    1971 units