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 | Ongoing |
| Reason | Malfunction of the hand pendant controlling movement of the therapy couch and nozzle may result in unintentional motion. Patient injury is possible if they come in contact with the nozzle or other objects in the treatment room. |
| Product | Mevion S250 and S250i Proton Therapy Systems hand pendant (P/N 10263 or P/N 37808) |
| Quantity | 39 (36 US, 3 OUS) |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of FL, MO, NJ, OH, OK, UT, DC and the country of Netherlands. |
| Initiated | 2022-02-01 |
| Classified | 2022-03-25 |
| Recall number | Z-0827-2022 |
| 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-0827-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/89758/
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