Recall archive / FDA device enforcement
Brand Name: Hitachi Proton Beam Therapy REF: PROBEAT-CR — FDA record Z-1430-2026
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Feb 6, 2026. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Brand Name: Hitachi Proton Beam Therapy REF: PROBEAT-CR
- Reason
- Software anomaly in the patient positioning system may result in positional discrepancy.
- Classification
- Class II
- Recalling firm
- Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha
- Quantity
- 1 unit
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1430-2026
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Serial Number: CRUS01/ UDI: (01)04560333350006(21)CRUS01(11)190920 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US distribution to states of: TX, Washington DC
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Mar 4, 2026
- Recall initiation date
- Feb 6, 2026
- Center classification date
- Feb 20, 2026
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.