Class IIReported 2026-03-04

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

Recalled by Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha

Reason for Recall

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

Recall Number

Z-1429-2026

Classification

Class II

Status

Ongoing

Category

device

Initiated

2026-02-06

Reported

2026-03-04

Distribution

US distribution to states of: TX, Washington DC

Code Info

Serial number: PTFR-01/ UDI:(01)04560333350204(11)240112(21)PTFR-01

Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.