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

Recall Z-2686-2020 — MEVION S250 Proton Radiation Treatment System; intended to deliver proton radiation treatment to patients

U.S. FDA — Device Enforcement · United States · 2020-06-23 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2686-2020
Date of alert
2020-06-23
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: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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