Class II — Mevion Medical Systems, Inc.
| Recalling firm | Mevion Medical Systems, Inc. |
|---|---|
| Registered facility | MEVION MEDICAL SYSTEMS, INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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 |
| Quantity | 8 units |
| Distribution | Worldwide distribution - US Nationwide distribution including in the states of DC, FL, MO, NJ, OK and the country of Netherlands. |
| Initiated | 2020-10-19 |
| Classified | 2020-11-24 |
| Terminated | 2021-08-31 |
| Recall number | Z-0485-2021 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Mevion Medical Systems, Inc. (Z-0485-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/86693/
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