HIGH

Brand Name: Hitachi Proton Beam Therapy System Ref: PROBEAT-FR

Software anomaly in the patient positioning system may result in positional discrepancy.

Quick Facts at a Glance

Recall Date
February 6, 2026
Hazard Level
HIGH
Brand
Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha
Geographic Scope
2 states

Hazard Information

Software anomaly in the patient positioning system may result in positional discrepancy.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha or your healthcare provider for instructions. Notification method: Visit

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Full Description

Brand Name: Hitachi Proton Beam Therapy System Ref: PROBEAT-FR. Reason: Software anomaly in the patient positioning system may result in positional discrepancy.. Classification: Class II. Quantity: 1. Distribution: US distribution to states of: TX, Washington DC

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Product Classification

Product Details

Model Numbers
Serial number: PTFR-01/ UDI:(01)04560333350204(11)240112(21)PTFR-01
Affected States
TX, DC
Report Date
March 4, 2026
Recall Status
ACTIVE

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