FDA-Device2020-12-02Class II
MEVION S250i, MEVION S250; Proton Radiation Treatment System - Product Usage: intended to deliver proton radiation treatment to patients with localized tumors or any other conditions susceptible to treatment by radiation
Mevion Medical Systems, Inc.
Hazard
Treatment beam information disappears on Treatment Console screen while beam delivery continues potential for harm to a patient could occur
Sold states
Worldwide distribution - US Nationwide distribution including in the states of DC, FL, MO, NJ, OK and the country of Netherlands.
Affected count
8 units
Manufactured in
300 Foster St, N/A, Littleton, MA, United States
Products
MEVION S250i, MEVION S250; Proton Radiation Treatment System - Product Usage: intended to deliver proton radiation treatment to patients with localized tumors or any other conditions susceptible to treatment by radiation
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0485-2021Don't want to check this manually?
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