Company: Varian Medical Systems, Inc.,
Date of Enforcement Report 2/6/2008
Class:ll

PRODUCT
Varian Real-Time Position Management System (RPM), A Respiratory Gating System; Version 1.7.3, All Models, Recall # Z-0554-2008

REASON
Erroneously Resetting: RPM System version 1.7.3, software failure can occur that affects the gated radiotherapy treatment when phase-based gating is used. RPM 1.7 erroneously resets the phase-based gating thresholds to system default during the treatment session, if the user accesses the Session options during the treatment session. This can lead to difference between the planned and delivered dose distribution for the treatment fraction accepted.

RECALLING FIRM/MANUFACTURER
Varian Medical Systems, Inc., Palo Alto, CA, by letter on September 26, 2007. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
59 units

DISTRIBUTION
Nationwide and Internationally