FDA-Device2026-03-04Class IIPROCESSING DEFECT
Hitachi Proton Beam Therapy system recalled for patient positioning software error
Check Hitachi Proton Beam Therapy positioning
Hitachi's Proton Beam Therapy system (model PROBEAT-CR) has a software issue that may cause the patient positioning system to be inaccurate during treatment. One unit was distributed in Texas and Washington, DC. No injuries have been reported.
- If you operate this device, contact Hitachi immediately for software verification or correction
- Do not rely on automatic positioning until the issue is resolved
- Verify patient positioning manually before each treatment
Hazard
Software anomaly in the patient positioning system may result in positional discrepancy.
Sold states
US distribution to states of: TX, Washington DC
Affected count
1 unit
Manufactured in
44-141-1,W 226, Wakashiba, Kashiwa, N/A, Japan
Products
Brand Name: Hitachi Proton Beam Therapy REF: PROBEAT-CR
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1430-2026Don't want to check this manually?
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