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Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha: Brand Name: Hitachi Proton Beam Therapy System Ref: PROBEAT-FR

Medical DevicesSource: FDA (device) · Date: 2026-03-04

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha
Product
Brand Name: Hitachi Proton Beam Therapy System Ref: PROBEAT-FR
Reason / hazard
Software anomaly in the patient positioning system may result in positional discrepancy.
Classification
Class II
Status
Ongoing
Distribution / sold at
US distribution to states of: TX, Washington DC
Recall initiated
2026-02-06
Code info
Serial number: PTFR-01/ UDI:(01)04560333350204(11)240112(21)PTFR-01
Product quantity
1
Voluntary mandated
Voluntary: Firm initiated
City
Kashiwa
State
N/A
Country
Japan
Event id
98330
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