FDA-Device2020-07-29Class II

MEVION S250 Proton Radiation Treatment System; intended to deliver proton radiation treatment to patients

Mevion Medical Systems, Inc.
Hazard

The perforated screen that divides the inside of the process water tank has a very sharp edge across the top of the Heat Exchanger leading to potential injury for servicer.

Sold states
MO, NJ, OK, FL, OH, DC, Netherlands
Affected count
8 units
Manufactured in
300 Foster St, N/A, Littleton, MA, United States
Products
MEVION S250 Proton Radiation Treatment System; intended to deliver proton radiation treatment to patients

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2686-2020

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