Company: Varian Medical Systems, Inc.
Date of Enforcement Report:1/1/2014
Class lI:

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.
Recall Number Z-0552-2014

REASON
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.

RECALLING FIRM/MANUFACTURER
Varian Medical Systems, Inc., Palo Alto, CA on 11/18/2013. Voluntary: Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
6701

DISTRIBUTION
Nationwide andI Internationally

___________________________________