HIGH

Hitachi Proton Beam Therapy System Recalled Due to Software Issue

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.

Quick Facts at a Glance

Recall Date
February 6, 2026
Hazard Level
HIGH
Brand
Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha
Category
Health & Personal Care
Sold At
Unknown
Geographic Scope
2 states
At-Risk Groups
GENERAL

Hazard Information

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

What You Should Do

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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About This Product

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.

Why This Is Dangerous

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.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

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.

Practical Guidance

How to identify if yours is affected

  1. Verify the model number of your device is PTFR-01.
  2. Check the serial number against the UDI provided: (01)04560333350204(11)240112(21)PTFR-01.
  3. If your device matches the recalled model, cease use immediately.

Where to find product info

The serial number can typically be found on the device's label or in the user manual.

What timeline to expect

Expect a response regarding your refund or replacement within 4-6 weeks after contacting Hitachi.

If the manufacturer is unresponsive

  • Document all communications with Hitachi and your healthcare provider.
  • Consider reaching out via multiple channels, such as phone and email.
  • If necessary, file a complaint with the FDA regarding unresponsive behavior.

How to prevent similar issues

  • Always check for recalls on medical devices regularly.
  • Ensure devices are up-to-date with the latest software patches from manufacturers.
  • Consult with healthcare providers about device safety before use.

Documentation advice

Keep copies of any communications regarding the recall, including emails and notes from phone calls.

Product Details

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.

Key Facts

  • Recalled product: Hitachi Proton Beam Therapy System
  • Recall date: February 6, 2026
  • Distribution: Texas and Washington D.C.
  • Stop using the device immediately
  • Contact Hitachi for further instructions

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product Details

Model Numbers
Serial number: PTFR-01/ UDI:(01)04560333350204(11)240112(21)PTFR-01
Affected States
TX, DC
Report Date
March 4, 2026
Recall Status
ACTIVE

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