BEUDAMED
    FDA Recall Terminated

    12C (AdaPTinsight) Affected component: AdaPTinsight software Product Usage: 12C is used with a charged particle or photon radiation therapy system for localization of the patient position with respect to the therapy equipment and to provide correction feedback to the radiation therapy system.

    Recall: Z-2109-2018 · Initiated October 28, 2016

    Recall

    Recall Number
    Z-2109-2018
    Event Number
    80219
    FEI Number
    3000256071
    Product Code
    LHN
    Status
    Terminated
    Root Cause
    Software change control
    Initiated
    October 28, 2016
    Terminated
    August 9, 2019
    Address
    Ion Beam Applications S.A. Chemin du Cyclotron, 3 Louvain La Neuve Belgium

    Description

    12C (AdaPTinsight) Affected component: AdaPTinsight software Product Usage: 12C is used with a charged particle or photon radiation therapy system for localization of the patient position with respect to the therapy equipment and to provide correction feedback to the radiation therapy system.

    Reason

    IBA is initiating this recall to address an issue identified with AdaPTinsight software and to reduce risk related to this problem.

    Action

    IBA mailed an Urgent Field Safety Notice to affected customers on 10/28/2016 to inform them of the issue. The issue will be solved in AdaPTinsights versions starting from Al 2.0. The solution was to be deployed on impacted IBA Proton Therapy sites by September 2017.

    Distribution

    Worldwide Distribution - US Nationwide in the states of LA, TX, Italy, Sweden and France. Each country's National Competent Authorities were notified of the firm's Field Safety Notice.

    Quantity

    5 units (12C)