Device product
ProBeam Proton Therapy System (HGA and HFB) Product Usage:ProBeam Proton Therapy System provides protons for precision radiotherapy of lesions, tumors, and conditions anywhere in the body. where radiation treatment is indicated.
Z-1846-2014
Product summary
- Event
- Event 68384
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1
- Official record key
device-enforcement:Z-1846-2014
Official wording
Reason: Anomaly with the ProBeam System where under certain conditions, the Treatment Control and Monitoring application could fail to send treatment history records to the ARIA database.
Code information: Codes: HFB0031, HGA0032, HGA0033, HGA0034, HFB0035.
Distribution pattern: US Distribution in tthe state of CA
Derived failure modes
-
Unknown
Anomaly with the ProBeam System where under certain conditions, the Treatment Control and Monitoring application could fail to send treatment history records to the ARIA database.