BEUDAMED
    FDA Enforcement Class II Terminated

    Proteus 235; Version: PTS-8 versions before PTS-8.7.2

    Recall: Z-0466-2022 · Reported January 19, 2022

    Enforcement

    Recall Number
    Z-0466-2022
    Event ID
    89267
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ion Beam Applications S.A.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 19, 2022
    Initiation Date
    November 29, 2021
    Classification Date
    January 7, 2022
    Termination Date
    February 20, 2024
    Address
    Chemin Du Cyclotron 3, N/A, Louvain-la-neuve, N/A, N/A, Belgium

    Description

    Proteus 235; Version: PTS-8 versions before PTS-8.7.2

    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.

    Code Info

    PAT.108 (US), PAT.110 (US), PAT.113 (US), PAT.114 (EU), SAT.119 (US).

    Distribution

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

    Quantity

    5 devices