Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha recalls Brand Name: Hitachi Proton Beam Therapy REF: PROBEAT-CR

Recall date

February 6, 2026

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1430-2026

FDA classification

Class II

Brand / firm

Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha

Sold / distributed

US distribution to states of: TX, Washington DC

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Brand Name: Hitachi Proton Beam Therapy REF: PROBEAT-CR