Device product
IBA Proton Therapy System - PROTEUS 235, PTS-10 versions, PTS-11 versions, and PTS-12 versions.
Z-1603-2024
Product summary
- Event
- Event 94297
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 8 units
- Official record key
device-enforcement:Z-1603-2024
Official wording
Reason: There is a risk of mistreatment as irradiation is not prevented when some safety parameters are out of tolerance.
Code information: PTS-10 versions, PTS-11 versions, and PTS-12 versions. UDI-DI: 05404013801138; Serial Numbers: SAT.123, SAT.126, SAT.133, SAT.140, SBF.105, SBF.113, SBF.128, SBF.135. All configurations.
Distribution pattern: US Nationwide distribution in the states of AR, FL, LA, KS, MI, TX, VA.
Derived failure modes
-
Unknown
There is a risk of mistreatment as irradiation is not prevented when some safety parameters are out of tolerance.