Company: Ion Beam Applications S.A.
Date of Enforcement Report: 1/19/2022
Class II
PRODUCT
Proteus 235; Version: PTS-8 versions before PTS-8.7.2
Recall Number: Z-0466-2022
REASON
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.
RECALLING FIRM/MANUFACTURER
Ion Beam Applications S.A. on 11/29/2021. Voluntary: Firm initiated
VOLUME OF PRODUCT IN COMMERCE
5 devices
DISTRIBUTION
U.S. Nationwide and International