Device product
Proteus 235-Proton Therapy System
Z-2155-2021
Product summary
- Event
- Event 88196
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 5 US; 8 OUS
- Official record key
device-enforcement:Z-2155-2021
Official wording
Reason: if the user forgets to select the trigger input manually while beam gating is prescribed for the patient, the proton irradiation will be delivered without gating. If the beam is not gated as prescribed, the treatment field may be delivered with an error in position
Code information: Serial Numbers: PAT.107 (EU), PAT.108 (US), PAT.109 (US), PAT.115 (EU), SAT.117 (EU), SAT.118 (RU), SAT.119 (US), SAT.120 (EU), SAT.122 (EU), SAT.125 (IN), SAT.126 (US), SAT.132 (EU), SAT.133 (US).
Distribution pattern: FL, PA, TN, TX, VA Foreign: Germany, Italy, Russia, Sweden , India, Netherlands
Derived failure modes
-
Unknown
if the user forgets to select the trigger input manually while beam gating is prescribed for the patient, the proton irradiation will be delivered without gating. If the beam is not gated as prescribed, the treatment field may be delivered with an error in position