BEUDAMED
    FDA Recall Terminated

    ARIA, versions 8.0 and 8.1; Varian Medical Systems, Palo Alto, CA. Product Usage: Aria Radiation Oncology product is a treatment and image management application. It enables the authorized user to enter, access, modify, store and archive treatment plan and image data from diagnostic studies.

    Recall: Z-2763-2011 · Initiated May 17, 2011

    Recall

    Recall Number
    Z-2763-2011
    Event Number
    58974
    Firm
    Varian Medical Systems, Inc. Oncology Systems
    FEI Number
    2916710
    Product Code
    IYE
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    May 17, 2011
    Posted
    July 8, 2011
    Terminated
    March 15, 2012
    Address
    911 Hansen Way, Palo Alto, CA, 94304-1028

    Description

    ARIA, versions 8.0 and 8.1; Varian Medical Systems, Palo Alto, CA. Product Usage: Aria Radiation Oncology product is a treatment and image management application. It enables the authorized user to enter, access, modify, store and archive treatment plan and image data from diagnostic studies.

    Reason

    An issue has been detected when using the RT Chart function in ARIA versions 8.0 and 8.1. When users select the "Convert to Setup Field" option, a Set-up field is created, that removes the DMLC plan components in order to create an open collimator field for setup purposes.

    Action

    Varian Medical Systems, Inc. sent an "URGENT MEDICAL DEVICE CORRECTION" letters on May 17, 2011, via Certified Mail to US; Federal Express to Canada. Foreign distribution will be handled by Varian Managers. The letter contained recommended actions. For additional information contact Varian Medical Systems, Inc at 888- 827-4265. ***12-20-12, AMENDED INFO ***: An additional letter was sent to consignees on 11/5/12 that Varian identified as also being affected by the recall.***

    Distribution

    Worldwide Distribution -- USA (nationwide) and countries of Algeria, Australia, Austria, Belgium, Brazil, Chile, China, Canada, Colombia, Denmark, Ecuador, Egypt, Finland, France, Germany, Hong Kong, India, Iraq, Ireland, Italy, Japan Jordan, Kuwait, Malaysia, Morocco, Netherlands, Oman, Pakistan, Panama, Portugal, Romania, Russia, South Korea, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Tunsia, Turkey, Ukraine, United Arab Emirates, and United Kingdom,

    Quantity

    357