FDA recall Z-1429-2026
Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha · Class II · device
Product
Brand Name: Hitachi Proton Beam Therapy System Ref: PROBEAT-FR
Reason for recall
Software anomaly in the patient positioning system may result in positional discrepancy.
Distribution
US distribution to states of: TX, Washington DC
Key facts
- Status
- Ongoing
- Initiation date
- 2026-02-06
- Report date
- 2026-03-04
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Kashiwa, N/A, Japan
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1429-2026