FDAHealthFebruary 6, 2026
Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha — Brand Name: Hitachi Proton Beam Therapy System Ref: PROBEAT-FR
⚠️ Software anomaly in the patient positioning system may result in positional discrepancy.
Is this relevant to me?
- Geography
- US, TX, DC
- Source agency
- FDA
- Category
- Health
- Published
- February 6, 2026
US distribution to states of: TX, Washington DC
What's affected?
- Product
- Brand Name: Hitachi Proton Beam Therapy System Ref: PROBEAT-FR
- Lot code
- Serial number: PTFR-01/ UDI:(01)04560333350204(11)240112(21)PTFR-01
Additional details
Serial number: PTFR-01/ UDI:(01)04560333350204(11)240112(21)PTFR-01
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 1.
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