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 | Recovery of Incorrect Isocenter -operational change |
| Product | MEVION S250 Product Usage: Proton Radiation Therapy System |
| Quantity | 6 units |
| Distribution | US Nationwide Distribution in the states of FL, MO, NJ, OH and OK, |
| Initiated | 2016-10-21 |
| Classified | 2016-11-14 |
| Terminated | 2017-05-10 |
| Recall number | Z-0410-2017 |
| 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-0410-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/75498/
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