Company: Varian Medical Systems, Inc
Date of Enforcement Report: 3/26/03
VARiS 1.4G and Vision/Soma Vision Radiation Therapy Systems; VARiS versions 6.1.33 and 6.2.19 in conjunction with Eclipse 6.x/Soma Vision 6.x. Recall # Z-0633*03.
The product has a software problem. This could result in a treatment without a motorized wedge where one had been planned.
Serial Numbers: 44, 260, 315, 495, 746, 751, 873, 907, 984, 1098, 1131, and 9045.
Varian Medical Systems, Inc., Palo Alto, CA, by letters on January 16, 2003 and February 4, 2003. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
CA, MA, NC, SC, PA, LA, Canada, Austria, Germany and Finland.