FDA DeviceClass IINotable

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

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

Date: 2026-03-04

FDA Class: Class II

Description

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

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