IBA Proton Therapy System - PROTEUS 235 ProteusPLUS and ProteusONE Software versions: PTS-8 versions, PTS-10 versions, PTS-11 versions, and PTS-12 versions

Reason: Safety Parameters Verification Mechanisms can be deactivated in clinical runtime

Code information: UDI-DI: 05404013801138 Serial Numbers: PAT.107 (DE), PAT.108 (US), PAT.109 (US), PAT.110 (US), PAT.111 (FR), PAT.112 (US), PAT.113 (US), PAT.114 (CZ), PAT.115 (IT), SAT.116 (US), SAT.117 (PL), SAT.118 (RU), SAT.119 (US), SAT.120 (DE), SAT.122 (SE), SAT.123 (US), SAT.125 (IN), SAT.126 (US), SAT.127 (TW), SAT.132 (NL), SAT.133 (US), SAT.136 (IN), SAT.140 (US), SBF.101 (FR), SBF.103 (JP), SBF.104 (JP), SBF.105 (US), SBF.107 (FR), SBF.112 (BE), SBF.113 (US), SBF.117 (ES), SBF.124 (IT), SBF.125 (SG), SBF.128 (US), SBF.135 (US).

Distribution pattern: Worldwide - US Nationwide distribution in the states of AK, NJ, PA, VA,OK,FL, KA, IL, LA, MI, TN , TX, VA and the countries of BE, CZ, DE, ES, FR, IN, IT, JP, NL, PL, RU, SE, SG, TW.