FDA recall Z-0466-2022

Ion Beam Applications S.A. · Class II · device

Product

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

IN USA: VA, OK, NJ, TN OUS: Czech Republic.

Key facts

Status: Terminated
Initiation date: 2021-11-29
Report date: 2022-01-19
Termination date: 2024-02-20
Voluntary/Mandated: Voluntary: Firm initiated
Location: Louvain-la-neuve, N/A, Belgium

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0466-2022