MEVION S250-Proton Radiation Therapy Product Usage: Proton Radiation… — Class II medical device recall Z-1122-2017
Terminated recall by Mevion Medical Systems, Inc., reported 2017-02-08, distributed nationwide. An error can occur causing Delta corrections to be lost when one setup field is closed and another is opened
| Recall number | Z-1122-2017 |
|---|---|
| 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 | 2016-12-16 |
| Classified | 2017-02-02 |
| Reported by FDA | 2017-02-08 |
| Terminated | 2017-04-13 |
| Distributed | Nationwide (US) |
| Quantity | 2 units |
Product
MEVION S250-Proton Radiation Therapy Product Usage: Proton Radiation Therapy
Reason for recall
An error can occur causing Delta corrections to be lost when one setup field is closed and another is opened
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-1122-2017. 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.