Cl ll Varian Eclipse Client software

Company: Varian Medical Systems.
Date of Enforcement Report 1/26/2011
Class ll:

PRODUCT
Varian Medical Systems, Eclipse Client software versions with build numbers from 7.3.10 through 8.6.15 (i.e. excluding 8.6.17); Model Number: H48; Radiation Treatment Planning System. Recall Z-0911-2011

REASON
Possible incorrect dose calculation: An anomaly in certain Eclipse versions where, under certain specific sequences of user actions, the dose distribution may fail to be re-calculated even though changes have been made which affect dose.

RECALLING FIRM/MANUFACTURER
Varian Medical Systems, Inc. Oncology Systems, Palo Alto, CA, by letters on August 6, 2010. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
7019

DISTRIBUTION
Nationwide and Internationally

Upcoming Training

62304, FDA, and Emerging Standards for Medical Device and HealthIT
Planned Instructors:  Brian Pate, John F. Murray, Jr
Location: Sunnyvale, CA, USA
Dates:  February 4-6, 2020

QSS Software Validation
Planned Instructors:  Brian Pate, John F. Murray, Jr
Location: Boston, MA, USA
Dates:  June 2-4, 2020

To pre-register and get info on deep discounts or if you have questions, email training@softwarecpr.com

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.