Brand Name: Hitachi Proton Beam Therapy REF: PROBEAT-CR — Class II medical device recall Z-1430-2026
Ongoing recall by Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha, reported 2026-03-04, distributed in DC, TX, WA. Software anomaly in the patient positioning system may result in positional discrepancy.
| Recall number | Z-1430-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha, Kashiwa, N/A, Japan |
| Recall initiated | 2026-02-06 |
| Classified | 2026-02-20 |
| Reported by FDA | 2026-03-04 |
| Distributed | DC, TX, WA |
| Quantity | 1 units |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 04560333350006 |
| Serial numbers | CRUS01 |
Product
Brand Name: Hitachi Proton Beam Therapy REF: PROBEAT-CR
Reason for recall
Software anomaly in the patient positioning system may result in positional discrepancy.
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-1430-2026. 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.