Device product
Proteus 235, Proton Therapy System a medical device designed to produce and delivers a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.
Z-0938-2018
Product summary
- Event
- Event 79230
- Status
- Terminated
- Classification
- Class II
- Quantity
- 37
- Official record key
device-enforcement:Z-0938-2018
Official wording
Reason: There is a risk of misalignment of the patient when using treatment plans with multiple isocenters.
Code information: PAT.000 (US), PAT.001 (CN), PAT.003 (KR), PAT.006 (US), PAT.107 (EU), PAT.108 (US), PAT.109 (US), PAT.110 (US), PAT.111 (EU), PAT.112 (US), PAT.113 (US), PAT.114 (EU), PAT.115 (EU), SAT.116 (US), SAT.117 (EU), SAT.119 (US), SAT.120 (EU), SAT.122 (EU), SAT.123 (US), SAT.126 (US), SAT.132 (EU), SAT.133 (US), SBF.101 (EU), SBF.105 (US)
Distribution pattern: Nationally
Derived failure modes
-
Unknown
There is a risk of misalignment of the patient when using treatment plans with multiple isocenters.