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 | An error can occur causing Delta corrections to be lost when one setup field is closed and another is opened |
| Product | MEVION S250-Proton Radiation Therapy Product Usage: Proton Radiation Therapy |
| Quantity | 2 units |
| Distribution | US Nationwide in the states of OK, NJ |
| Initiated | 2016-12-16 |
| Classified | 2017-02-02 |
| Terminated | 2017-04-13 |
| Recall number | Z-1122-2017 |
| 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-1122-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/76090/
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