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    12C

    FDA Recall
    Terminated ·Product code LHN·September 16, 2016

    Proteus ONE and Proteus Plus

    FDA Recall
    Terminated ·Product code LHN·September 16, 2016

    IBA Proton Therapy System - PROTEUS 235 - Designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.

    FDA Recall
    Open, Classified ·Ion Beam Applications S.A. Chemin Du Cyclotron 3 Ottignies-Louvain-La-Neuve Belgium·Product code LHN·May 10, 2024

    IBA Proton Therapy System - PROTEUS 235. PTS-11 versions, PTS-12 versions with Orion PPS version OSS6.0. Configured with Orion Patient Positioning System.

    FDA Recall
    Open, Classified ·Ion Beam Applications S.A. Chemin Du Cyclotron 3 Ottignies-Louvain-La-Neuve Belgium·Product code LHN·September 18, 2023

    IBA Proton Therapy System - PROTEUS 235- Designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation

    FDA Recall
    Open, Classified ·Ion Beam Applications S.A. Chemin Du Cyclotron 3 Ottignies-Louvain-La-Neuve Belgium·Product code LHN·July 10, 2024

    Large Stealth Chamber, Catalog Numbers: DS50-001-XL-T, DS50-002-XL-T, DS50-003-XL-T, DS50-102-XL-T, DS50-103-XL-T

    FDA Recall
    Terminated ·Iba Dosimetry·Product code IYE·April 26, 2017

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

    FDA Recall
    Terminated ·Ion Beam Applications S.A. Chemin Du Cyclotron 3 Louvain-la-neuve Belgium·Product code LHN·November 29, 2021

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

    FDA Recall
    Open, Classified ·Ion Beam Applications S.A. Chemin Du Cyclotron 3 Ottignies-Louvain-La-Neuve Belgium·Product code LHN·July 8, 2024

    IBA Proton Therapy System - PROTEUS 235

    FDA Recall
    Open, Classified ·Ion Beam Applications S.A. Chemin Du Cyclotron 3 Ottignies-Louvain-La-Neuve Belgium·Product code LHN·February 3, 2026

    The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) Proteus 235, Beam Management System (PBS)

    FDA Recall
    Terminated ·Product code LHN·April 11, 2016

    adaPT insight (12C), v1.3.2, PAT.109 (US), Treatment room 4: I2C 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 device.

    FDA Recall
    Terminated ·Product code LHN·November 7, 2014

    iba COMPASS SW Version 3.0, Catalog Number CS10-100 (medical linear accelerator) radiological

    FDA Recall
    Terminated ·Iba Dosimetry Gmbh Bahnhofstr. 5 Schwarzenbruck Germany·Product code IYE·August 20, 2013

    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.

    FDA Recall
    Terminated ·Product code LHN·October 28, 2016

    Proteus 235, Pencil Beam Scanning version PTS-6.4.11.X 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.

    FDA Recall
    Terminated ·Product code LHN·October 19, 2017

    IBA Proton Therapy System - PROTEUS 235, PTS-10 versions, PTS-11 versions, and PTS-12 versions.

    FDA Recall
    Open, Classified ·Ion Beam Applications S.A. Chemin Du Cyclotron 3 Ottignies-Louvain-La-Neuve Belgium·Product code LHN·March 4, 2024

    Proteus235- Proton Therapy System: to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation

    FDA Recall
    Open, Classified ·Ion Beam Applications S.A. 3 Chemin Du Cyclotron Louvain-la-neuve Belgium·Product code LHN·April 20, 2022

    Proteus 235- designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation

    FDA Recall
    Open, Classified ·Ion Beam Applications S.A. Chemin Du Cyclotron 3 Louvain-la-neuve Belgium·Product code LHN·June 14, 2021

    Proteus 235 The PTS 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.

    FDA Recall
    Terminated ·Product code LHN·August 7, 2016

    Proteus 235-Proton Therapy System

    FDA Recall
    Open, Classified ·Ion Beam Applications S.A. Chemin Du Cyclotron 3 Louvain-la-neuve Belgium·Product code LHN·May 26, 2021

    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.

    FDA Recall
    Terminated ·Product code LHN·November 1, 2017