FDA recall, , Moderate risk
Hitachi Proton Beam Therapy
The Hitachi Proton Beam Therapy System has a software anomaly in its patient positioning system that may cause positional discrepancy.
Summary by Recall Canary from the FDA notice
What happened
Hitachi, Ltd. Radiation Oncology Systems, of Kashiwa, Japan, recalled the Hitachi Proton Beam Therapy System, models PROBEAT-FR and PROBEAT-CR, on February 6, 2026, due to a software anomaly in the patient positioning system that may result in positional discrepancy. The FDA added the recall to its Enforcement Report on February 20, 2026, and the affected systems were located in Texas, Washington, and the District of Columbia.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
2 products
Match the UDI-DI and serial number listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
Brand Name: Hitachi Proton Beam Therapy System Ref: PROBEAT-FR
- UDI-DI
- 04560333350204
- Serial number
- PTFR-01
Brand Name: Hitachi Proton Beam Therapy REF: PROBEAT-CR
- UDI-DI
- 04560333350006
- Serial number
- CRUS01
Recall details
- Company began the recall
- Company
- Hitachi, Ltd. Radiation Oncology Systems, KashiwanohaKashiwa, Japan
- Hazard
- Software defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98330
- Recall numbers
- Z-1429-2026 to Z-1430-2026
- Recall type
- Voluntary: Firm initiated
- How the company first told customers
- Visit
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
Summary updated
