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MEDICAL DEVICE RECALLMODERATE
Hitachi Proton Beam Therapy System
Hitachi is recalling the PROBEAT-FR Proton Beam Therapy System due to a software anomaly that may cause patient positioning discrepancies.
What to do
Contact Hitachi, Ltd. Radiation Oncology Systems for software update instructions and further guidance regarding the use of the affected system.
Why it was recalled
Software anomaly in the patient positioning system may result in positional discrepancy.
How to identify it
UPC 04560333350204
Brand Name: Hitachi Proton Beam Therapy System
Where it was sold
Distributed in US-DC, US-TX, US-WA.
Official source
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Editorial summary by Recall Canary · last updated 2026-06-05 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification