FDA-Device2026-03-04Class II
Brand Name: Hitachi Proton Beam Therapy REF: PROBEAT-CR
Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha
Hazard
Software anomaly in the patient positioning system may result in positional discrepancy.
Sold states
US distribution to states of: TX, Washington DC
Affected count
1 unit
Manufactured in
44-141-1,W 226, Wakashiba, Kashiwa, N/A, Japan
Products
Brand Name: Hitachi Proton Beam Therapy REF: PROBEAT-CR
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1430-2026Original summary
Brand Name: Hitachi Proton Beam Therapy REF: PROBEAT-CR Software anomaly in the patient positioning system may result in positional discrepancy. Serial Number: CRUS01/ UDI: (01)04560333350006(21)CRUS01(11)190920 Distribution: US distribution to states of: TX, Washington DC Affected quantity: 1 unit
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