Mevion Medical Systems, Inc. recalls MEVION S250i, MEVION S250; Proton Radiation Treatment System - Product Usage: intended to deliver proton radiation trea…

Recall date

October 19, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0485-2021

FDA classification

Class II

Brand / firm

Mevion Medical Systems, Inc.

Sold / distributed

Worldwide distribution - US Nationwide distribution including in the states of DC, FL, MO, NJ, OK and the country of Netherlands.

Why it was recalled

Treatment beam information disappears on Treatment Console screen while beam delivery continues potential for harm to a patient could occur

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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