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Sources: EU EUDAMED, US FDA
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FDA Recall
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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
FDA Recall
Terminated
·Product code LHN·February 9, 2017
Proteus 235 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.
FDA Recall
Terminated
·Ion Beam Applications S.A. Chemin Du Cyclotron 3 Louvain-la-neuve Belgium·Product code LHN·July 17, 2020
Proteus 235, Universal Nozzle with snout 300x400; PBS dedicated nozzle with snout XL Product Usage: Device is designed to produce and deliver 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
·Ion Beam Applications S.A. Chemin Du Cyclotron 3 Louvain-la-neuve Belgium·Product code LHN·June 27, 2018
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
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 Product Usage: 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
·Ion Beam Applications S.A. Chemin Du Cyclotron 3 Louvain-la-neuve Belgium·Product code LHN·December 12, 2018
Proteus 235 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.
FDA Recall
Terminated
·Ion Beam Applications S.A. Chemin Du Cyclotron 3 Louvain-la-neuve Belgium·Product code LHN·April 21, 2020
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
ProteusPLUS and ProteusONE- designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation Proteus 235
FDA Recall
Open, Classified
·Ion Beam Applications S.A. Chemin Du Cyclotron 3 Louvain-la-neuve Belgium·Product code LHN·February 15, 2022
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
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
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
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·May 10, 2024
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