FDA-Device2016-11-23Class II

MEVION S250 Product Usage: Proton Radiation Therapy System

Mevion Medical Systems, Inc.
Hazard

Recovery of Incorrect Isocenter -operational change

Sold states
US Nationwide Distribution in the states of FL, MO, NJ, OH and 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-0410-2017

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