Company: Varian Medical Systems, Inc.
Date of Enforcement Report: 9/1/04
Class: II

PRODUCT
Varian Mdical device and software systems. Version Numbers 6.2.27 and 6.2.35, 510k number K001643. Recall # Z-1314-04.

REASON
A malfunction in the software of the VARiS versions 6.2.27 and 6.2.35 which is used to set up radiation therapy devices which will reset parameters to null for future treatments if a patient receives treatment on a non-varian machine and a varian machine and a non-varian field is loaded in the treatment session.

CODE
Serial numbers H8__ (31901, 50044, 50149, 50181, 50187,50260, 50284, 50315, 50357, 50397, 50430, 50804, 50873, 51096, 51152, 51186, 51082, 51463, 51534, 51580, 51658, 51773, 51787, 59032, 59040, 59041, 59045).

RECALLING FIRM/MANUFACTURER
Varian Medical Systems, Inc., Palo Alto, CA, by letter on June 14, 2004. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
28 units.

DISTRIBUTION
Nationwide and Internationally.