Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0485-2021 — 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

U.S. FDA — Device Enforcement · United States · 2020-10-19 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0485-2021
Date of alert
2020-10-19
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Mevion Medical Systems, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00864366000100
Reported risk: Treatment beam information disappears on Treatment Console screen while beam delivery continues potential for harm to a patient could occur
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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