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Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha FDA Recalls

2 recalls on file across devices, 0 of them Class I and 2 still open. Matched by name to HTHIY.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product
Brand Name: Hitachi Proton Beam Therapy System Ref: PROBEAT-FRClass IIFeb 6, 2026Software anomaly in the patient positioning system may resul
Brand Name: Hitachi Proton Beam Therapy REF: PROBEAT-CRClass IIFeb 6, 2026Software anomaly in the patient positioning system may resul

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