Recall Z-1430-2026— Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha

Name: FDA recall Z-1430-2026
Creator: U.S. Food and Drug Administration
Published: 2026-02-06

Class II · Ongoing

Class II FDA medical device recall by Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha, initiated 2026-02-06. It names 2 FDA 510(k) clearances: K201042, K191801. Product: Brand Name: Hitachi Proton Beam Therapy REF: PROBEAT-CR. Reason: Software anomaly in the patient positioning system may result in positional discrepancy..

Recalling firm: Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha
Classification: Class II
Status: Ongoing
Initiated: 2026-02-06
Firm location: Kashiwa, N/A, Japan

510(k) clearances named in this recall

2 on FDA's record

K201042 — PROBEAT-CRHitachi , Ltd.·cleared 2020-07-13
K191801 — PROBEAT-CRHitachi , Ltd.·cleared 2019-09-13

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.