Brand Name: Hitachi Proton Beam Therapy REF: PROBEAT-CR recall (Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha)
Medical deviceClass IIOngoing
Summary: Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha is recalling Brand Name: Hitachi Proton Beam Therapy REF: PROBEAT-CR. Reason: Software anomaly in the patient positioning system may result in positional discrepancy.
What is being recalled
Brand Name: Hitachi Proton Beam Therapy REF: PROBEAT-CR
Why
Software anomaly in the patient positioning system may result in positional discrepancy.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
US distribution to states of: TX, Washington DC (states named: District of Columbia, Texas)
How to tell if yours is affected
Serial Number: CRUS01/ UDI: (01)04560333350006(21)CRUS01(11)190920
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-1430-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | February 6, 2026 |
| Reported | March 4, 2026 |
| Company | Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha |
| Company location | Kashiwa, N/A, Japan |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 1 unit |
More recalls from Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha · all medical device recalls · recalls from February 2026