Device product
IBA Proton Therapy System - 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-2693-2024
Product summary
- Event
- Event 95024
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 19 units
- Official record key
device-enforcement:Z-2693-2024
Official wording
Reason: Temporary deactivation of collision detection for Forte Robotic Patient Positioning System occasionally experiences issues
Code information: UDI-DI: (01)05404013801138 Serial Numbers; PAT.108 (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.126 (US), SBF.101 (FR), SBF.103 (JP), SBF.104 (JP), SBF.105(US).
Distribution pattern: IL,LA, NJ, MI,OK, TN, TX, VA, WA Foreign: Czech Republic France Germany Italy Japan Poland Russia Sweden
Derived failure modes
-
Unknown
Temporary deactivation of collision detection for Forte Robotic Patient Positioning System occasionally experiences issues