Home / Recalls / Medical Devices
Varian Medical Systems, Inc. recalls Plan Parameters workspace within Eclipse Treatment Planning System Version 11 and 13; ARIA Radiation Oncology versions
Recalled January 1, 2014 · FDA recall Z-0552-2014 · Varian Medical Systems
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. · FDA Class II
Units
6701
Sold at
Worldwide Distribution.
Description
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.
Product
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.
Manufacturer(s)
Varian Medical Systems, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →