ProBeam Proton Therapy System — Class II medical device recall Z-1846-2014
Terminated recall by VARIAN MEDICAL SYSTEMS PARTICLE THERAPY GMBH, reported 2014-07-02, distributed in CA. Anomaly with the ProBeam System where under certain conditions, the Treatment Control and Monitoring applicati
| Recall number | Z-1846-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | VARIAN MEDICAL SYSTEMS PARTICLE THERAPY GMBH, BERGISCH GLADBACH, N/A, Germany |
| Recall initiated | 2014-05-09 |
| Classified | 2014-06-20 |
| Reported by FDA | 2014-07-02 |
| Terminated | 2014-11-12 |
| Distributed | CA |
| Quantity | 1 |
Product
ProBeam Proton Therapy System (HGA and HFB) Product Usage:ProBeam Proton Therapy System provides protons for precision radiotherapy of lesions, tumors, and conditions anywhere in the body. where radiation treatment is indicated.
Reason for recall
Anomaly with the ProBeam System where under certain conditions, the Treatment Control and Monitoring application could fail to send treatment history records to the ARIA database.
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-1846-2014. 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.