Z-0466-2022 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- January 19, 2022
- Initiation Date
- November 29, 2021
- Termination Date
- February 20, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5 devices
Product Description
Proteus 235; Version: PTS-8 versions before PTS-8.7.2
Reason for Recall
Proton Therapy System (PTS) software can be started in the clinical environment (clinical user) while some processes are still running in the test environment (tcs user). Initiating the startup of the clinical processes in the environment is not prevented even if some processes of the test environment (tcs) are still running. It may lead to situations where the system is using test processes without notifying the clinical user. If the versions of the processes are different between both environments, this could have an impact on patient treatments.
Distribution Pattern
IN USA: VA, OK, NJ, TN OUS: Czech Republic.
Code Information
PAT.108 (US), PAT.110 (US), PAT.113 (US), PAT.114 (EU), SAT.119 (US).