Hitachi recalled its Proton Beam Therapy System on February 6, 2026, due to a software anomaly that may result in positional discrepancies. The recall affects one unit distributed in Texas and Washington D.C. Healthcare providers and patients must stop using the device immediately.
Software anomaly in the patient positioning system may result in positional discrepancy.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha or your healthcare provider for instructions. Notification method: Visit
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The Hitachi Proton Beam Therapy System is a medical device used for cancer treatment, providing targeted radiation therapy. Healthcare providers use it to precisely position patients for treatment.
A software anomaly in the patient positioning system can lead to discrepancies in patient positioning, risking incorrect treatment delivery. This poses a serious risk to patient safety and treatment efficacy.
This recall is not part of a broader industry pattern.
The recall affects the use of the Proton Beam Therapy System for patients requiring radiation treatment. It necessitates immediate action from healthcare providers to ensure patient safety, potentially delaying treatment.
The serial number can typically be found on the device's label or in the user manual.
Expect a response regarding your refund or replacement within 4-6 weeks after contacting Hitachi.
Keep copies of any communications regarding the recall, including emails and notes from phone calls.
The recalled product is the Hitachi Proton Beam Therapy System, model PROBEAT-FR, with serial number PTFR-01 and UDI (01)04560333350204(11)240112(21)PTFR-01. It was distributed in the United States, specifically to Texas and Washington D.C.
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