Reported Mar 4, 2026 · Ongoing
Brand Name: Hitachi Proton Beam Therapy System Ref: PROBEAT-FR
Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha · 44-141-1,W 226 · Kashiwa, N/A · N/A
Is this the product you have?
- Brand NameHitachi
- Proton Beam Therapy System RefPROBEAT-FR
- Lot codes and dates
- Serial numberPTFR-01/
- UDI(01)04560333350204(11)240112(21)PTFR-01
- Amount recalled
- 1
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Software anomaly in the patient positioning system may result in positional discrepancy.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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