BEUDAMED
    FDA Recall Terminated

    Eclipse Treatment Planning System versions 11, 13.0, 13.5 and 13.6; Model number: H48; Product Usage: The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients with malignant or benign diseases. Eclipse TPS is used to plan external beam irradiation with photon, electron and proton beams, as well as for internal irradiation (brachytherapy) treatments.

    Recall: Z-0805-2016 · Initiated January 11, 2016

    Recall

    Recall Number
    Z-0805-2016
    Event Number
    73092
    Firm
    Varian Medical Systems, Inc.
    FEI Number
    2916710
    Product Code
    MUJ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    January 11, 2016
    Posted
    February 12, 2016
    Terminated
    October 25, 2017
    Address
    911 Hansen Way, Palo Alto, CA, 94304-1028

    Description

    Eclipse Treatment Planning System versions 11, 13.0, 13.5 and 13.6; Model number: H48; Product Usage: The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments for patients with malignant or benign diseases. Eclipse TPS is used to plan external beam irradiation with photon, electron and proton beams, as well as for internal irradiation (brachytherapy) treatments.

    Reason

    When using PBC 11.0.31 to calculate the dose for a conventional arc field with more than 100 segments for Eclipse versions 11.0, 13.0, 13.5 or 13.6, the displayed dose does not correspond to the calculated Monitor Units (MU). Potential for unintended radiation exposure.

    Action

    Varian sent an Urgent Medical Device Correction letters dated January 11, 2016 to all affected customers. Letters were also sent to Varian Sales and Marketing and Service organizations to notify them of the recall. The letter identified the affected product, problem and actions to be taken. For questions customers were instructed to contact their local Varian Medical Systems Customer Support District or Regional Manager.

    Distribution

    Worldwide Distribution - US Nationwide and the countries of Albania, Guadeloupe, Norway,Algeria, Guam, Pakistan, Argentina, Guatemala, Panama,Australia, Hong Kong, Paraguay, Austria, Hungary, Peru,Azerbaijan, Iceland, Philippines, Bangladesh, India, Poland,Belgium, Indonesia ,Portugal, Belorussia, Iran, Puerto Rico,Brazil, Iraq, Qatar, Brunei Darussalam, Ireland, Reunion,Bulgaria, Israel, Romania, Burma, Italy, Russia,'Canada, Jamaica, Saudi Arabia, Chile, Japan, Singapore, China, Kazakhstan, Slovakia, Colombia, Kuwait, South Africa, Costa Rica, Latvia, South Korea,Czech Republic, Lebanon, Spain, Denmark, Libya, Sweden, Dominican Republic, Lithuania, Switzerland, Ecuador, Luxembourg, Taiwan, Egypt, Macau, Thailand, El Salvador, Macedonia, Trinidad and Tobago, Estonia, Madagascar, Tunisia, Finland, Malaysia, Turkey, France, Malta, Ukraine, French Polynesia, Mexico, United Arab Emirates, Georgia, Monaco, United Kingdom, Germany, Morocco, Venezuela, Ghana, Netherlands, Vietnam,Greece, New Zealand, and Zimbabwe.

    Quantity

    9499