Hitachi recalls proton beam therapy systems with software positioning anomalies that may cause patient misalignment. Affected units require immediate review by medical professionals.
Software anomaly in the patient positioning system may result in positional discrepancy.
Hitachi is recalling proton beam therapy systems that have a software issue potentially causing patient positioning errors. This could lead to inaccurate treatment delivery if not corrected.
The software anomaly in the patient positioning system may cause the treatment beam to be misaligned with the target area. This could result in incorrect radiation delivery to the patient's tissues. The risk is specific to medical procedures requiring precise positioning.
Medical facilities using Hitachi Proton Beam Therapy Systems with serial numbers starting PTFR-01 are affected. Patients receiving treatment with these systems are at risk of inaccurate positioning.
Check for serial numbers starting with PTFR-01 on the system. The product reference is PROBEAT-FR. This recall applies to systems sold with the specific UDI code (01)04560:033350204(11)240112(21)PTFR-01.
Reach out to your medical facility to confirm if your system is affected and get guidance on next steps.
The recall states a software anomaly may cause positional discrepancy, but does not specify injury risk. Medical facilities are advised to review the system.
Look for serial numbers starting with PTFR-01 on the system. The product reference is PROBEAT-FR with the specific UDI code (01)04560333350204(11)240112(21)PTFR-01.
Contact your medical facility to determine if your system is affected and follow their instructions.
We’ve drafted a message you can send Hitachi to request your refund or repair — edit it as you like.
Subject: Recall Z-1429-2026 — Hitachi Hitachi Hello, I own a Hitachi that is covered by recall Z-1429-2026 from Hitachi. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
