Company:Varian Medical Systems
Date of Enforcement Report 2/25/2009
Class:ll
PRODUCT
Varian Medical Systems Eclipse treatment planning system, Model Number H48, versions 6.5/7.x and Inspiration 8.0. Recall # Z-0861-2009
REASON
Possible incorrect wedge orientation in treatment: Software labeling was issued without warning message relating to preservation of user selected values for Siemens wedge orientation, wedge limits and SAD values for Elekta machines, and collimator operating limits for Saturne Machines when the software version is upgraded.
RECALLING FIRM/MANUFACTURER
Varian Medical Systems oncology Systems, Palo Alto, CA, by letter dated November 21, 2008. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
516 units
DISTRIBUTION
Nationwide and Internationally
