Company: Varian Medical Systems Inc,
Date of Enforcement Report 2/20/2008
Class:ll

PRODUCT
Varian brand VARiS 1.4g (Medical Charged Particle Radiation Therapy System, Record and Verify System); Linear Accelerator with RTP Exchange v6.2, v6.6, & v8.0, All Models, Recall # Z-0720-2008

REASON
Incorrect Software Validation. The ARC treatment plans containing a Dose Dynamic MLC for IMRT delivery that will not be recognized properly by the system. Under these circumstances, an arc plan can be administered to a patient whereby the gantry will not rotate, resulting in delivery to a single location rather than through the gantry arc.

RECALLING FIRM/MANUFACTURER
Varian Medical Systems Inc, Palo Alto, CA, by letter on October 2, 2007. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
440 units

DISTRIBUTION
Nationwide and Internationally