BEUDAMED
    FDA Recall Terminated

    Eclipse Radiation Treatment Planning System, model H48; Varian Medical Systems Inc..

    Recall: Z-2702-2011 · Initiated May 3, 2011

    Recall

    Recall Number
    Z-2702-2011
    Event Number
    58836
    Firm
    Varian Medical Systems, Inc. Oncology Systems
    FEI Number
    2916710
    Product Code
    MUJ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    May 3, 2011
    Posted
    June 29, 2011
    Terminated
    July 9, 2014
    Address
    911 Hansen Way, Palo Alto, CA, 94304-1028

    Description

    Eclipse Radiation Treatment Planning System, model H48; Varian Medical Systems Inc..

    Reason

    In affected Analytical Anisotropy Algorithm versions when modeling the second source, the collimator jaw positions are read from the first control point of the field. This can cause the delivered dose to be higher than planned locally by up to 10%.

    Action

    Varian Medical Systems, Inc. Oncology Systems sent a "Urgent Medical Device Correction" letters on May 3, 2011 ***12-12-12, AMENDED INFO ***: An additional letter was sent to consignees on 11/5/12 that Varian identified as also being affected by the recall.*** The letter contained recommended actions. For additional information contact Varian Medical Systems, Inc. at 888- 827-4265.

    Distribution

    Worldwide distribution; Nationwide (USA) and the countries of Vietnam, Venezuela, United Kingdom, United Arab Emirates, Ukraine, Turkey, Tunisia, Trinidad and Tobago, Thailand, Taiwan, Syria, Switzerland, Sweden, Sri Lanka, Spain, South Korea, South Africa, Slovenia, Singapore, Saudi Arabia, Russia, Romania, Qatar, Portugal. Poland, Philippines, Panama, Pakistan, Norway, New Zealand, Netherlands, Morocco, Mexico, Malaysia, Macau, Lithuania, Libya, Latvia, Kuwait, Kazakjstan, Japan, Italy, Israel, Ireland, Iraq, Indonesia, India, Hungary, Hong Kong,, Guam, Greece, Germany, France, Finland, Egypt, Ecuador, Denmark, Czech Republic, Colombia, China, Canada, Brazil, Belgium, Belarus, Bangladesh, Bahrain, Austria, Australia, Argentenia, Algeria and Canada.

    Quantity

    5201 units ***12-12-12 AMENDED TO: 5448 units***