Recall – PTS inadvertently allows test software to run in clinical environment

Company: Ion Beam Applications S.A.
Date of Enforcement Report: 1/19/2022
Class II

PRODUCT

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