MEVION S250 — Class II medical device recall Z-1271-2014
Terminated recall by Mevion Medical Systems, Inc., reported 2014-04-02, distributed nationwide. Geometric positioning error can occur after a rotational correction has been applied to one or more treatment
| Recall number | Z-1271-2014 |
|---|---|
| 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 | 2014-03-05 |
| Classified | 2014-03-21 |
| Reported by FDA | 2014-04-02 |
| Terminated | 2014-04-03 |
| Distributed | Nationwide (US) |
| Quantity | 1 units |
Product
MEVION S250, System, Radiation Therapy, Charged-Particle, Medical used for Proton Radiation Therapy Product Usage: Proton Radiation Therapy
Reason for recall
Geometric positioning error can occur after a rotational correction has been applied to one or more treatment fields
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-1271-2014. 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.