Reported Mar 4, 2026 · Ongoing

Brand Name: Hitachi Proton Beam Therapy REF: PROBEAT-CR

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 REFPROBEAT-CR
Lot codes and dates
  • Serial NumberCRUS01/
  • UDI(01)04560333350006(21)CRUS01(11)190920
Amount recalled
1 unit

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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:58 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.