Company: Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha
Date of Enforcement Report: 2/20/2026
Class: II
PRODUCT:
Brand Name: Hitachi Proton Beam Therapy System Ref: PROBEAT-FR
Recall Number:
Z-1429-2026
REASON:
Software anomaly in the patient positioning system may result in positional discrepancy.
RECALLING FIRM/MANUFACTURER:
Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha
VOLUME:
1
DISTRIBUTION:
US distribution to states of: TX, Washington DC
