Brand Name: Hitachi Proton Beam Therapy System Ref: Probeat-fr

Recall Summary Hitachi is recalling its Proton Beam Therapy System (model PROBEAT-FR) due to a software problem in the patient positioning system that could cause patients to be positioned incorrectly during treatment. This is classified as a Class II recall, meaning the issue could result in serious injury or adverse health effects. The recall affects Hitachi proton beam therapy systems used in medical facilities.

Recalling firm

Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha 44-141-1, W 226 Wakashiba Kashiwa Japan

Product

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

Category

consumer product recall

Country

United States

Agency

FDA-DEVICES

Recall date

2026-02-06

Status

Open, Classified

Official recall notice from FDA-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/fe6647ab-712b-47aa-ab52-ab048184c957