Device product
Proteus 235, Version PTS-11.0.1.2 and PTS-11.0.2 Product Usage: A device 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-2424-2018
Product summary
- Event
- Event 80298
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3 units
- Official record key
device-enforcement:Z-2424-2018
Official wording
Reason: Correction vector confirmation message is lost if access point is changed after sending the correction vector. As a result, the patient will be treated in the setup position or treatment position instead of the corrected position.
Code information: Serial Numbers: SAT.122 (EU) SAT.132 (EU) SAT.133 (US)
Distribution pattern: Worldwide Distribution - US Nationwide in the states of FL and the countries of Sweden, The Netherlands
Derived failure modes
-
Unknown
Correction vector confirmation message is lost if access point is changed after sending the correction vector. As a result, the patient will be treated in the setup position or treatment position instead of the corrected position.