FDA-Device2026-03-04Class IIPROCESSING DEFECT
Hitachi Proton Beam Therapy System recalled for patient positioning software error
Check Hitachi proton therapy system positioning
Hitachi's Proton Beam Therapy System (model PROBEAT-FR) has a software issue that could cause the patient positioning system to place a patient slightly out of the intended treatment position. This affects one system installed in the US. No injuries have been reported.
- If you operate this system, contact Hitachi immediately for guidance before using it
- Do not proceed with patient treatments until the positioning system is verified or corrected by the manufacturer
Hazard
Software anomaly in the patient positioning system may result in positional discrepancy.
Who it affects
Adults
Illnesses reported
None reported
Sold states
US distribution to states of: TX, Washington DC
Affected count
1
Manufactured in
44-141-1,W 226, Wakashiba, Kashiwa, N/A, Japan
Products
Brand Name: Hitachi Proton Beam Therapy System Ref: PROBEAT-FR
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1429-2026Don't want to check this manually?
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