BEUDAMED
    FDA Recall 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 · Initiated September 28, 2015

    Recall

    Recall Number
    Z-0170-2016
    Event Number
    72374
    Firm
    Varian Medical Systems, Inc.
    FEI Number
    2916710
    Product Code
    MUJ
    Status
    Terminated
    Root Cause
    Software design (manufacturing process)
    Initiated
    September 28, 2015
    Posted
    October 30, 2015
    Terminated
    May 12, 2017
    Address
    911 Hansen Way, Palo Alto, CA, 94304-1028

    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.

    Action

    Varian sent an Urgent Medical Device Corrections letter dated September 29, 2015 via trackable method to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were informed that Varian is developing a technical correction for this issue. Customers will be contacted by a Varian Field Service. A copy of the notification is to be kept with the most current product labeling and all appropriate personnel in the radiation oncology department should be aware of this issue. For questions contact your local Varian Medical Systems Customer Support District or Regional Manager

    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