Company: Varian Medical
Date of Enforcement Report 12/1/2010
Class ll:

PRODUCT
Varian brand TrueBeam and TrueBeam STx, Model Number: TMX- H19. Recall # Z-0106-2011

REASON
Due to a software anomaly, guidance-based couch shift values may not be applied as expected when the operator selects “Apply Shift” and presses Motion Enable buttons. This can result in the actual patient position differing from that position indicated by the imaging application affecting position accuracy and precision.

RECALLING FIRM/MANUFACTURER
Varian Medical Systems Oncology Systems, Palo Alto, CA, by letter dated May 24, 2010. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
2 units

DISTRIBUTION
NY, Switzerland