BEUDAMED
    FDA Recall Terminated

    Proteus 235, Pencil Beam Scanning, PTS-9.4.X, PTS-10.0.1.1 The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. The PTS may include a fixed small beam treatment room dedicated to the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation localized to the head and neck.

    Recall: Z-0943-2018 · Initiated November 1, 2017

    Recall

    Recall Number
    Z-0943-2018
    Event Number
    79229
    FEI Number
    3000256071
    Product Code
    LHN
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    November 1, 2017
    Terminated
    March 29, 2019
    Address
    Ion Beam Applications S.A. Chemin du Cyclotron, 3 Louvain La Neuve Belgium

    Description

    Proteus 235, Pencil Beam Scanning, PTS-9.4.X, PTS-10.0.1.1 The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. The PTS may include a fixed small beam treatment room dedicated to the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation localized to the head and neck.

    Reason

    The internal configuration of the electrometers and the Real-Time control boards of the Dekimo Scanning Controller is not checked before each patient treatment.

    Action

    The firm, IBA, sent an "Urgent Field Safety Notice" dated 10/31/2017 to customers on 10/31/2017. The notice described the product, problem and actions to be taken. stating the following: There is no specific recommendation for the user. IBA will provide an Internal User notice to the IBA site team, requesting the operator to select the Beam Delivery Point CGTR, by clicking on the BDP button, before each patient treatment preparation (see Annex 1 for details). This will begin the check of the internal configuration of all the elements of the Dekimo Scanning Controller. An updated system will be deployed on February 28, 2017. If you have any questions, contact Customer Complaints & Vigilance Director at [email protected] or +32 10 203 787 or helpdesk at +32 2 507 20 81 (available 24/7).

    Distribution

    Worldwide Distribution: US (nationwide) to: MI only and country of: France.

    Quantity

    3