Device product
IBA Proton Therapy System - PROTEUS 235. PTS-11 versions, PTS-12 versions with Orion PPS version OSS6.0. Configured with Orion Patient Positioning System.
Z-0295-2024
Product summary
- Event
- Event 93293
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 5 (US), 9 (OUS)
- Official record key
device-enforcement:Z-0295-2024
Official wording
Reason: The patient positioning system can perform motions in unexpected directions, creating the potential for crushing of the patient between the patient positioning devices.
Code information: UDI-DI: (01)05404013801138. Serial numbers (US): SAT133, SAT140, SBF113, SBF128, SBF135 & (OUS): SAT125, SAT127, SAT132, SAT136, SBF107, SBF112, SBF117, SBF124, & SBF125.
Distribution pattern: Worldwide - US Nationwide distribution in the states of Arkansas, Florida, Kansas, and Virginia and the countries of Belgium, France, India, Italy, Netherlands, Spain, Singapore, and Taiwan.
Derived failure modes
-
Unknown
The patient positioning system can perform motions in unexpected directions, creating the potential for crushing of the patient between the patient positioning devices.