Mevion S250 and S250i Proton Therapy Systems hand pendant — Class II medical device recall Z-0827-2022
Ongoing recall by Mevion Medical Systems, Inc., reported 2022-04-06, distributed nationwide. Malfunction of the hand pendant controlling movement of the therapy couch and nozzle may result in unintention
| Recall number | Z-0827-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mevion Medical Systems, Inc., Littleton, MA, United States |
| Recall initiated | 2022-02-01 |
| Classified | 2022-03-25 |
| Reported by FDA | 2022-04-06 |
| Distributed | Nationwide (US) |
| Countries outside the US | NL |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 00864366000100, 00864366000124 |
Product
Mevion S250 and S250i Proton Therapy Systems hand pendant (P/N 10263 or P/N 37808)
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0827-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.