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

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

Between the dates of February 5-11, 2026, Hitachi, Ltd, issued an "URGENT: MEDICAL DEVICE RECALL" notification dated January 21, 2026, via Service Team Manager to affected consignees. Hitachi is asking consignees to take the following actions: 1. Until the PPS software has been updated with the corrected version, users are instructed to follow the System Operation instruction in the document. 2. Users are also asked to post the document in a prominent space and sign its cover. 3. Complete and return the acknowledgment and receipt form. Action by the firm: Hitachi plans to update the PPS software to a corrected version that prevents the mismatch between the commanded error correction parameter and the internal variable. starting in late March 2026 and the users will be contacted after the update. If you have any questions, please call QA Manager at Tel: (408) 986-6300. Monday through Friday, 8:00 AM to 5:00 PM, Central Time.

• FDA enforcement recordOfficial FDA database entry for Z-1430-2026
• FDA 510(k) clearance · K191801The device's official FDA premarket clearance record
• FDA 510(k) clearance · K201042The device's official FDA premarket clearance record
• FDA device classification · LHNOfficial FDA classification for this device type
• CFR regulation · 21 CFR 892.5050The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Hitachi, Ltd. Radiation Oncology Systems, KashiwanohaSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.