FDA-Device2016-11-23Class II
MEVION S250 Product Usage: Proton Radiation Therapy System
Mevion Medical Systems, Inc.
Hazard
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
Sold states
US Nationwide Distribution in the states of: FL, MO, NJ, OH, OK
Affected count
6 units
Manufactured in
300 Foster Street, N/A, Littleton, MA, United States
Products
MEVION S250 Product Usage: Proton Radiation Therapy System
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0411-2017Don't want to check this manually?
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