10
Nov
2008

Cl Il Varian RV Software

0

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

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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