Company: Varian Medical Systems Oncology Systems
Date of Enforcement Report 8/20/2008
Varian Medical Systems On-Board Imager, Versions 1.0.15 and 1.2.05 Imaging Accessory to Medical Linear Accelerator. The On-Board Imager Device is used for verification of correct patient position in relation to isocenter and verification of the treatment fields in relation to anatomical and/or fiducial landmarks, Recall # Z-1442-2008
If used with a third party radiation therapy treatment planning software system, mistreatment may occur because of a misalignment.
Varian Medical Systems Oncology Systems, Palo Alto, CA, by letters starting January 3, 2008. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
Nationwide and Internationally