FDA-Device2014-01-01Class II
Plan Parameters workspace within Eclipse Treatment Planning System Version 11 and 13; ARIA Radiation Oncology versions 11 and 13 Acuity, versions 11 and 13. Manufactured by Varian Medical Systems Palo Alto, CA. Used in radiation therapy simulation.
Varian Medical Systems, Inc.
Hazard
An anomaly has been traced to a software deficiency within the Plan Parameters workspace. When a dose relevant parameter is changed and "do no clear MUs and Reference Point dose" is selected, the Monitor units may change.
Sold states
Worldwide Distribution.
Affected count
6701
Manufactured in
911 Hansen Way, N/A, Palo Alto, CA, United States
Products
Plan Parameters workspace within Eclipse Treatment Planning System Version 11 and 13; ARIA Radiation Oncology versions 11 and 13 Acuity, versions 11 and 13. Manufactured by Varian Medical Systems Palo Alto, CA. Used in radiation therapy simulation.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0552-2014Don't want to check this manually?
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