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

Recall Z-2406-2020 — MEVION S250i, MEVION S250; Proton Radiation Treatment System

U.S. FDA — Device Enforcement · United States · 2020-05-15 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2406-2020
Date of alert
2020-05-15
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: Couch Correction moves sent after using a 3D CT scan are partially lost if the previous correction sent or recorded had some of the Couch Correction checkboxes turned off
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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