Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha: Brand Name: Hitachi Proton Beam Therapy REF: PROBEAT-CR
Read the official notice at FDA (device) →
The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha
- Product
- Brand Name: Hitachi Proton Beam Therapy REF: PROBEAT-CR
- Reason / hazard
- Software anomaly in the patient positioning system may result in positional discrepancy.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- US distribution to states of: TX, Washington DC
- Recall initiated
- 2026-02-06
- Code info
- Serial Number: CRUS01/ UDI: (01)04560333350006(21)CRUS01(11)190920
- Product quantity
- 1 unit
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Kashiwa
- State
- N/A
- Country
- Japan
- Event id
- 98330
Free daily digest + "My products" watchlist