Device product
Proteus 235
Z-1695-2017
Product summary
- Event
- Event 76696
- Status
- Terminated
- Classification
- Class II
- Quantity
- 8 worldwide, 4 in U.S.
- Official record key
device-enforcement:Z-1695-2017
Official wording
Reason: The Proton Therapy System can allow gantry rotation even if the snout is not properly locked.
Code information: Serial numbers: PAT.000, PAT.001, PAT.003, PAT.006, PAT.108, PAT.111, SAT.119, SAT.120
Distribution pattern: Distributed in MA, FL, VA, and TN. China, South Korea, France and Germany
Derived failure modes
-
Unknown
The Proton Therapy System can allow gantry rotation even if the snout is not properly locked.