MEVION S250 for Proton Radiation Therapy — Class II medical device recall Z-1529-2016
Terminated recall by Mevion Medical Systems, Inc., reported 2016-04-27, distributed nationwide. Possibility of Gantry Motion with Aperture or Compensator only partially inserted. An Aperture may fall out du
| Recall number | Z-1529-2016 |
|---|---|
| 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 | 2016-03-15 |
| Classified | 2016-04-20 |
| Reported by FDA | 2016-04-27 |
| Terminated | 2017-08-24 |
| Distributed | Nationwide (US) |
| Quantity | 5 |
Product
MEVION S250 for Proton Radiation Therapy
Reason for recall
Possibility of Gantry Motion with Aperture or Compensator only partially inserted. An Aperture may fall out during Gantry motion. It is possible that it can hit a patient and cause traumatic injury or death.
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-1529-2016. 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.