Brand Name: Hitachi Proton Beam Therapy System Ref: PROBEAT-FR
FDA Recall #Z-1429-2026 — Class II — February 6, 2026
Product Description
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.
Recalling Firm
Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha — Kashiwa, N/A
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
1
Distribution
US distribution to states of: TX, Washington DC
Code Information
Serial number: PTFR-01/ UDI:(01)04560333350204(11)240112(21)PTFR-01
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated