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Home › FDA recalls › Brand Name: Hitachi Proton Beam Therapy System Ref: PROBEA
CLASS II · ModerateFDA

Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha recalls Brand Name: Hitachi Proton Beam Therapy System Ref: PROBEAT-FR

📅 Feb 6, 2026 · 📍 DC, TX, WA
Recalling company
Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha
Product
Brand Name: Hitachi Proton Beam Therapy System Ref: PROBEAT-FR
Reason
Software anomaly in the patient positioning system may result in positional discrepancy.
Classification
Class II – may cause temporary or medically reversible health consequences
Recall date
Feb 6, 2026
Reported
Mar 4, 2026
Distribution
US distribution to states of: TX, Washington DC
Status
Ongoing
Quantity
1
Lot / codes
Serial number: PTFR-01/ UDI:(01)04560333350204(11)240112(21)PTFR-01
Company location
Kashiwa, N/A
Recall type
Voluntary: Firm initiated
Recall number
Z-1429-2026
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-1429-2026 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.