Device product
Proteus 235- designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation
Z-2434-2021
Product summary
- Event
- Event 88449
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 27 worldwide, 11 in U.S.
- Official record key
device-enforcement:Z-2434-2021
Official wording
Reason: Users may be misled by the popup message displayed by the Proton Therapy System when the Oncology Information System appears disconnected, may cause mistreatment
Code information: PAT.006 (US), PAT.107 (EU), PAT.108 (US), PAT.110 (US), PAT.112 (US), PAT.113 (US), PAT.114 (EU), PAT.115 (EU), SAT.116 (US), SAT.118 (RU), SAT.119 (US), SAT.120 (EU), SAT.122 (EU), SAT.123 (US), SAT.125 (IN), SAT.126 (US), SAT.132 (EU), SBF.101 (EU), SBF.103 (JP), SBF.104 (JP), SBF.105 (US), SBF.107 (EU), SBF.109 (UK), SBF.110 (UK), SBF.113 (US), SBF.115 (UK), SBF.117 (EU).
Distribution pattern: Worldwide distribution - US Nationwide distribution in the states of FL, OK, VA, IL, NJ, TN, WA, LA, TX, MI and the countries of Germany, Italy, Russia, Sweden, India, Japan, France, England, Spain.
Derived failure modes
-
Unknown
Users may be misled by the popup message displayed by the Proton Therapy System when the Oncology Information System appears disconnected, may cause mistreatment