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Hitachi Proton Beam Therapy System
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MEDICAL DEVICE RECALLMODERATE

Hitachi Proton Beam Therapy System

Hitachi recalls Proton Beam Therapy System over patient positioning software anomaly.

What to do

Contact Hitachi, Ltd. Radiation Oncology Systems for instructions on updating the software and verifying patient positioning before treatment.

Recalled
Listed
Updated
Recall No.
Z-1429-2026
Agency
FDA
Firm
Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha
Recall ID
98330
Status
ONGOING

Why it was recalled

Hitachi, Ltd. is recalling its Proton Beam Therapy System due to a software anomaly in the patient positioning system that may result in positional discrepancy, potentially affecting treatment accuracy.

Is mine affected?

Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

Brand Name: Hitachi Proton Beam Therapy

ProductRecall #UDI-DI
System Ref: PROBEAT-FRZ-1429-202604560333350204
REF: PROBEAT-CRZ-1430-202604560333350006

Where it was sold

Distributed in District of Columbia, Texas, and Washington.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Official source

View on U.S. Food and Drug Administration →

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Editorial summary by Recall Canary · summary updated 2026-08-04 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification