FDA-Device2026-03-04Class IIPROCESSING DEFECT
Hitachi Proton Beam Therapy system recalled for patient positioning software error
What this means
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
The agency's original wording
Hazard
Software anomaly in the patient positioning system may result in positional discrepancy.
Intended for
Adults
Illnesses reported
None reported
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-1430-2026Want us to check the next one for you?
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