BEUDAMED
    FDA Recall Terminated

    ARIA versions 8.0 and 8.1 Varian Medical Systems, Palo Alto, CA 94304 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 provided tools to verify performed treatments. ARIA also includes optional tools to manage the oncology department's clinical and business information.

    Recall: Z-1905-2011 · Initiated February 18, 2011

    Recall

    Recall Number
    Z-1905-2011
    Event Number
    58112
    Firm
    Varian Medical Systems, Inc. Oncology Systems
    FEI Number
    2916710
    Product Code
    IYE
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 18, 2011
    Posted
    April 7, 2011
    Terminated
    June 19, 2012
    Address
    911 Hansen Way, Palo Alto, CA, 94304-1028

    Description

    ARIA versions 8.0 and 8.1 Varian Medical Systems, Palo Alto, CA 94304 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 provided tools to verify performed treatments. ARIA also includes optional tools to manage the oncology department's clinical and business information.

    Reason

    An anomaly was identified in the ARIA version 8.0 and 8.1, when an image sequence template is added to a field in RT chart and a CIAO (Completely Irradiated Aperture Opening) is calculated, the resulting CIAO display at 4DITC may be incorrect.

    Action

    Varian Medical Systems sent an Urgent Medical Device Correction letter dated February 18, 2011, to all affected customers via Federal Express.. The letter identified the product, the problem, and the action to be taken by the customer. Varian has made design changes to address the issue in ARIA Radiation Oncology versions 8.2 and later. A corrective action will be undertaken to upgrade all affected items. For questions regarding this recall call US and Canada 1-888-VARIAN5 (888-827-4265. Europe +41 41 749 8844

    Distribution

    Worldwide Distribution - USA (nationwide) and the countries of Algeria, Australia, Azerbaijan, Bahrain, Bangladesh, Barius, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Guadeloupe, HOng Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kuwait, Lebanon, Lithania, Malaysia, Maurtama, Morocco, Netherlands, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Reunion, Romania, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, and Yemen.

    Quantity

    645