MEVION S250i — Class II medical device recall Z-0705-2019
Terminated recall by Mevion Medical Systems, Inc., reported 2019-01-16, distributed in DC. Treatment is allowed to continue (via partials) in situations where dDose1 interlock has tripped
| Recall number | Z-0705-2019 |
|---|---|
| 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 | 2018-10-01 |
| Classified | 2019-01-09 |
| Reported by FDA | 2019-01-16 |
| Terminated | 2020-04-10 |
| Distributed | DC |
| Quantity | 1 units |
| UPC / GTIN / UDI-DI | 00864366000124 |
| Serial numbers | S250I-0007 |
Product
MEVION S250i
Reason for recall
Treatment is allowed to continue (via partials) in situations where dDose1 interlock has tripped
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-0705-2019. 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.