Device product
Brand Name: Hitachi Proton Beam Therapy REF: PROBEAT-CR
Z-1430-2026
Product summary
- Event
- Event 98330
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1 unit
- Official record key
device-enforcement:Z-1430-2026
Official wording
Reason: Software anomaly in the patient positioning system may result in positional discrepancy.
Code information: Serial Number: CRUS01/ UDI: (01)04560333350006(21)CRUS01(11)190920
Distribution pattern: US distribution to states of: TX, Washington DC
Derived failure modes
-
Device software or design
Software anomaly