MEVION S250i — Class II medical device recall Z-0485-2021
Terminated recall by Mevion Medical Systems, Inc., reported 2020-12-02, distributed nationwide. Treatment beam information disappears on Treatment Console screen while beam delivery continues potential for
| Recall number | Z-0485-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mevion Medical Systems, Inc., Littleton, MA, United States |
| Recall initiated | 2020-10-19 |
| Classified | 2020-11-24 |
| Reported by FDA | 2020-12-02 |
| Terminated | 2021-08-31 |
| Distributed | Nationwide (US) |
| Countries outside the US | NL |
| Quantity | 8 units |
| UPC / GTIN / UDI-DI | 00864366000100, 00864366000124 |
Product
MEVION S250i, MEVION S250; Proton Radiation Treatment System - Product Usage: intended to deliver proton radiation treatment to patients with localized tumors or any other conditions susceptible to treatment by radiation
Reason for recall
Treatment beam information disappears on Treatment Console screen while beam delivery continues potential for harm to a patient could occur
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-0485-2021. 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.