Company: Varian Medical Systems
Date of Enforcement Report 11/5/2008
Class:ll
PRODUCT
Varian RV Software Varian Treatment for Non-Varian Linacs Version 6.6.5042 and 6.6.5043; Model Number: H46; Designed to assist the operator of a radiation therapy device in providing accurate treatment setups for each patient by monitoring set up parameters and preventing the radiation therapy from commencing irradiation while any parameter is out of conformance with the treatment plan, Recall # Z-0164-2009
REASON
A malfunction within the Varis software might result in a misadministration (under dose). The software does not correctly interpret the number, causing field parameters having decimal values to be incorrect.
RECALLING FIRM/MANUFACTURER
Varian Medical Systems Oncology Systems, Palo Alto, CA, by letter on June 2, 2008. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
18 units
DISTRIBUTION
Nationwide, Canada, Austria, France, Germany, South Korea, Sweden, and the UK
