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Mevion Medical Systems, Inc. recalls MEVION S250i, MEVION S250; Proton Radiation Treatment System - Product Usage: intended to deliver proton radiation treat
Recalled December 2, 2020 · FDA recall Z-0485-2021 · Mevion Medical Systems
Hazard
Treatment beam information disappears on Treatment Console screen while beam delivery continues potential for harm to a patient could occur · FDA Class II
Units
8 units
Sold at
Worldwide distribution - US Nationwide distribution including in the states of DC, FL, MO, NJ, OK and the country of Netherlands.
Description
Treatment beam information disappears on Treatment Console screen while beam delivery continues potential for harm to a patient could occur
Product
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
Manufacturer(s)
Mevion Medical Systems, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →