MEVION S250 Proton Radiation Treatment System — Class II medical device recall Z-2686-2020
Terminated recall by Mevion Medical Systems, Inc., reported 2020-07-29, distributed in DC, FL, MO, NJ, OH, OK. The perforated screen that divides the inside of the process water tank has a very sharp edge across the top o
| Recall number | Z-2686-2020 |
|---|---|
| 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 | 2020-06-23 |
| Classified | 2020-07-22 |
| Reported by FDA | 2020-07-29 |
| Terminated | 2020-12-09 |
| Distributed | DC, FL, MO, NJ, OH, OK |
| Countries outside the US | NL |
| Quantity | 8 units |
| UPC / GTIN / UDI-DI | 00864366000100, 00864366000124 |
Product
MEVION S250 Proton Radiation Treatment System; intended to deliver proton radiation treatment to patients
Reason for recall
The perforated screen that divides the inside of the process water tank has a very sharp edge across the top of the Heat Exchanger leading to potential injury for servicer.
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-2686-2020. 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.