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
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha
- Product type
- Proton Beam Therapy System
- Model numbers
- Serial number: PTFR-01/ UDI:(01)04560333350204(11)240112(21)PTFR-01
- Sold at
- Unknown
- Where affected
- TX, DC
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
February 6, 2026
Reported by FDA DEVICE
March 4, 2026
RecallRadar source check
March 11, 2026
Consumer action
Use the official remedy and keep documentation.
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
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
- Verify the model number of your device is PTFR-01.
- Check the serial number against the UDI provided: (01)04560333350204(11)240112(21)PTFR-01.
- 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.
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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
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