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
- Multiple Retailers
- 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: CRUS01/ UDI: (01)04560333350006(21)CRUS01(11)190920
- Sold at
- Multiple Retailers
- 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 used in radiation oncology to precisely target tumors while minimizing exposure to surrounding healthy tissues. Medical facilities purchase these devices for advanced cancer treatment.
Why This Is Dangerous
The software anomaly may lead to incorrect patient positioning, which could affect treatment outcomes and patient safety. This issue necessitates immediate action from users.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Patients and healthcare providers must stop using the device immediately, impacting treatment schedules and requiring alternative solutions.
Practical Guidance
How to identify if yours is affected
- Check the serial number of the device to confirm if it is the affected unit.
- Refer to the recall notice for specific identification guidance.
- Contact Hitachi for verification if uncertain.
Where to find product info
Serial numbers are usually located on the device's back panel or manufacturer label.
What timeline to expect
Expect a realistic timeline of 4-6 weeks for processing refunds or replacements.
If the manufacturer is unresponsive
- Document all correspondence with Hitachi.
- Reach out to regulatory bodies if no response is received.
- Consider legal consultation for unresolved issues.
How to prevent similar issues
- Research medical device recalls before purchase.
- Inquire about software updates and safety certifications.
- Consult reviews and professional opinions on medical equipment.
Documentation advice
Keep copies of all communications and any documentation related to the recall for your records.
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Product Details
The recalled product is the Hitachi Proton Beam Therapy System, reference number PROBEAT-CR. The only unit affected is identified by Serial Number: CRUS01, UDI: (01)04560333350006(21)CRUS01(11)190920. It distributed in the U.S. states of Texas and Washington D.C.
Key Facts
- Recall date: February 6, 2026
- Distribution states: Texas, Washington D.C.
- Quantity recalled: 1 unit
- Classification: Class II
- Risk level: High
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Safety Guide
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