FDA DeviceClass IINotable

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

Date: 2026-03-04
Brand: Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha
Category: Medical Device
FDA Class: Class II

Description

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

Hazard

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

Remedy

1

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