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 is allowed to continue (via partials) in situations where dDose1 interlock has tripped |
| Product | MEVION S250i |
| Quantity | 1 unit |
| Distribution | DC |
| Initiated | 2018-10-01 |
| Classified | 2019-01-09 |
| Terminated | 2020-04-10 |
| Recall number | Z-0705-2019 |
| 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-0705-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/81751/
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