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.
Product 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 for Recall
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.
Details
- Recalling Firm
- Varian Medical Systems, Inc.
- Units Affected
- 9499
- 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.
- Location
- Palo Alto, CA
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