BEUDAMED
    FDA Enforcement Class II Ongoing

    IBA Proton Therapy System - PROTEUS 235 ProteusPLUS and ProteusONE Software versions: PTS-8 versions, PTS-10 versions, PTS-11 versions, and PTS-12 versions

    Recall: Z-3089-2024 · Reported September 18, 2024

    Enforcement

    Recall Number
    Z-3089-2024
    Event ID
    95080
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Ion Beam Applications S.A.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 18, 2024
    Initiation Date
    July 8, 2024
    Classification Date
    September 10, 2024
    Address
    Chemin Du Cyclotron 3, Ottignies-Louvain-La-Neuve, N/A, Belgium

    Description

    IBA Proton Therapy System - PROTEUS 235 ProteusPLUS and ProteusONE Software versions: PTS-8 versions, PTS-10 versions, PTS-11 versions, and PTS-12 versions

    Reason

    Safety Parameters Verification Mechanisms can be deactivated in clinical runtime

    Code Info

    UDI-DI: 05404013801138 Serial Numbers: PAT.107 (DE), PAT.108 (US), PAT.109 (US), PAT.110 (US), PAT.111 (FR), PAT.112 (US), PAT.113 (US), PAT.114 (CZ), PAT.115 (IT), SAT.116 (US), SAT.117 (PL), SAT.118 (RU), SAT.119 (US), SAT.120 (DE), SAT.122 (SE), SAT.123 (US), SAT.125 (IN), SAT.126 (US), SAT.127 (TW), SAT.132 (NL), SAT.133 (US), SAT.136 (IN), SAT.140 (US), SBF.101 (FR), SBF.103 (JP), SBF.104 (JP), SBF.105 (US), SBF.107 (FR), SBF.112 (BE), SBF.113 (US), SBF.117 (ES), SBF.124 (IT), SBF.125 (SG), SBF.128 (US), SBF.135 (US).

    Distribution

    Worldwide - US Nationwide distribution in the states of AK, NJ, PA, VA,OK,FL, KA, IL, LA, MI, TN , TX, VA and the countries of BE, CZ, DE, ES, FR, IN, IT, JP, NL, PL, RU, SE, SG, TW.

    Quantity

    35 units