Device product
Proteus 235, Proton Therapy System
Z-1830-2017
Product summary
- Event
- Event 76804
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2 worldwide, 1 in U.S.
- Official record key
device-enforcement:Z-1830-2017
Official wording
Reason: In specific circumstances, the user is able to restart an aborted irradiation without having to select the correct partial irradiation data.
Code information: Serial Number: SAT.123 (US), and SBF.101 (EU). Versions PTS-9.3.1.2 and PTS-9.4.0
Distribution pattern: Distribution in US (to Louisiana), and France.
Derived failure modes
-
Unknown
In specific circumstances, the user is able to restart an aborted irradiation without having to select the correct partial irradiation data.