Company: Mevion Medical Systems, Inc.
Date of Enforcement Report 11/23/2016
MEVION S250 Product Usage: Proton Radiation Therapy System
Recall Number Z-0411-2017
Software defect:2D projection of contours in Verity. The defect causes structures to appear off from their true position in the DRR and the radiograph with an error that increases with the distance of the structure from isocenter.
Mevion Medical Systems, Inc., Littleton, MA on 11/14/2016. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
US Nationwide Distribution in the states of: FL, MO, NJ, OH, OK