18 results
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11ms
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Sources: EU EUDAMED, US FDA
Mevion S250 and S250i Proton Therapy Systems hand pendant (P/N 10263 or P/N 37808)
FDA Recall
Open, Classified
·Mevion Medical Systems, Inc.·Product code LHN·February 1, 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
Michael Graves with Stryker Highback Chair-intended for pediatric and adult person guest and patient seating use in an indoor medical setting, Model Number 4853, Part #4853000000
FDA Recall
Open, Classified
·Stryker Medical Division of Stryker Corporation·Product code KMN·May 12, 2021
Brand Name: Hitachi Proton Beam Therapy REF: PROBEAT-CR
FDA Recall
Open, Classified
·Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha 44-141-1, W 226 Wakashiba Kashiwa Japan·Product code LHN·February 6, 2026
Brand Name: PROBEAT Product Name: PROBEAT-FR Model/Catalog Number: N/A Software Version: N/A Product Description: The PROBEAT-FR is a proton beam irradiation system, which provides a therapeutic proton beam for clinical treatment. It is designed to deliver a proton beam with the prescribed dose, dose distribution and directed to the prescribed patient treatment site. Component: N/A
FDA Recall
Open, Classified
·Hitachi America, Ltd., Particle Therapy Division·Product code LHN·May 27, 2024
Brand Name: PROBEAT Product Name: PROBEAT-CR Model/Catalog Number: N/A Software Version: N/A Product Description: The PROBEAT-CR is a proton beam irradiation system, which provides a therapeutic proton beam for clinical treatment. It is designed to deliver a proton beam with the prescribed dose, dose distribution and directed to the prescribed patient treatment site. Component: N/A
FDA Recall
Open, Classified
·Hitachi America, Ltd., Particle Therapy Division·Product code LHN·May 27, 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
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
Stretcher Chair-for use in all acute care hospitals and medical outpatient services Model Number: 5050 Part # 5050000000
FDA Recall
Open, Classified
·Stryker Medical Division of Stryker Corporation·Product code KMN·May 12, 2021
Brand Name: Hitachi Proton Beam Therapy System Ref: PROBEAT-FR
FDA Recall
Open, Classified
·Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha 44-141-1, W 226 Wakashiba Kashiwa Japan·Product code LHN·February 6, 2026
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
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
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
Brand Name: PROBEAT Product Name: PROBEAT-V Model/Catalog Number: N/A Software Version: N/A Product Description: The PROBEAT-V is a proton beam irradiation system, which provides a therapeutic proton beam for clinical treatment. It is designed to deliver a proton beam with the prescribed dose, dose distribution and directed to the prescribed patient treatment site. Component: N/A
FDA Recall
Open, Classified
·Hitachi America, Ltd., Particle Therapy Division·Product code LHN·May 27, 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
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