Device product
Brand Name: Hitachi Proton Beam Therapy System Ref: PROBEAT-FR
Z-1429-2026
Product summary
- Event
- Event 98330
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1
- Official record key
device-enforcement:Z-1429-2026
Official wording
Reason: Software anomaly in the patient positioning system may result in positional discrepancy.
Code information: Serial number: PTFR-01/ UDI:(01)04560333350204(11)240112(21)PTFR-01
Distribution pattern: US distribution to states of: TX, Washington DC
Derived failure modes
-
Device software or design
Software anomaly