FDA DevicesClass II
Brand Name: Hitachi Proton Beam Therapy System Ref: PROBEAT-FR
Published: March 4, 2026Recall ID: Z-1429-2026Category: devicesCountry: US
Reason for Recall / Hazard
Software anomaly in the patient positioning system may result in positional discrepancy.
Product Description & Identification
Brand Name: Hitachi Proton Beam Therapy System Ref: PROBEAT-FR
Affected Products
Brand Name: Hitachi Proton Beam Therapy System Ref: PROBEAT-FR
Additional Source Details
| Field | Value |
|---|---|
| City | Kashiwa |
| State | N/A |
| Event id | 98330 |
| Address 1 | 44-141-1,W 226 |
| Address 2 | Wakashiba |
| Code info | Serial number: PTFR-01/ UDI:(01)04560333350204(11)240112(21)PTFR-01 |
| Postal code | N/A |
| Report date | 20260304 |
| Product type | Devices |
| Product quantity | 1 |
| Reason for recall | Software anomaly in the patient positioning system may result in positional discrepancy. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260206 |
| Initial firm notification | Visit |
| Center classification date | 20260220 |
Overview
- Recalling FirmHitachi, Ltd. Radiation Oncology Systems, Kashiwanoha
- StatusOngoing
- Risk LevelClass II
- DistributionUS distribution to states of: TX, Washington DC