Device product
MEVION S250 Product Usage: Proton Radiation Therapy System
Z-0411-2017
Product summary
- Event
- Event 75494
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6 units
- Official record key
device-enforcement:Z-0411-2017
Official wording
Reason: 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
Code information: Serial Numbers: S250-0001 through S250-0006
Distribution pattern: US Nationwide Distribution in the states of: FL, MO, NJ, OH, OK
Derived failure modes
-
Device software or design
Software defect:2D projection of contours in Verity. The defect