Kashiwa-Shi, JP · 2 510(k) clearances · 2 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| LHN | System, Radiation Therapy, Charged-Particle, Medical | Class II | Radiology | 2 | 2024-01-12 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2026-02-06 | Class II | Ongoing | Z-1430-2026 | Brand Name: Hitachi Proton Beam Therapy REF: PROBEAT-CR | — | Software anomaly in the patient positioning system may result in positional discrepancy. |
| 2026-02-06 | Class II | Ongoing | Z-1429-2026 | Brand Name: Hitachi Proton Beam Therapy System Ref: PROBEAT-FR | — | Software anomaly in the patient positioning system may result in positional discrepancy. |