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 | Completing Setup Without Program Move Complete Can Cause An Isocenter Error |
| Product | MEVION S250 Product Usage: Proton Radiation Therapy |
| Quantity | 6 units |
| Distribution | US Nationwide in the states of FL, MO, NJ and OK |
| Initiated | 2016-10-31 |
| Classified | 2016-11-14 |
| Terminated | 2017-06-29 |
| Recall number | Z-0409-2017 |
| 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-0409-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/75496/
Alerts for Mevion Medical Systems, Inc.
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.