BEUDAMED
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    EUB-5500 VISION 5500 Diagnostic Ultrasound Scanner w/Step 5 (V05-7) Software. Imaging device intended to provide the physician with physiological and clinical information.

    FDA Recall
    Terminated ·Hitachi Medical Systems America Inc·Product code LHN·February 25, 2008

    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

    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

    PROBEAT-V, software versions 4.8.1S, and 5.1M Radiation therapy system.

    FDA Recall
    Terminated ·Hitachi America, Ltd., Power Systems Division·Product code LHN·April 15, 2019

    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

    Proteus 235 Proton Therapy System Legacy Software version 7.2.7 and higher, models 110, 112, 113, and 116. Proton therapy

    FDA Recall
    Terminated ·Product code LHN·December 4, 2013

    MEVION S250, used for proton radiation therapy.

    FDA Recall
    Terminated ·Mevion Medical Systems, Inc.·Product code LHN·November 10, 2014

    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

    MEVION S250/MEVION S250i Proton Beam Radiation therapy system Product Usage: Indicated for the delivery of radiation for the treatment of patients with localized tumors or other conditions susceptible to treatment by radiation.

    FDA Recall
    Terminated ·Mevion Medical Systems, Inc.·Product code LHN·June 29, 2018

    Proteus 235, Proton Therapy System

    FDA Recall
    Terminated ·Product code LHN·March 21, 2017

    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

    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

    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

    OSI, Allegro 6800 Imaging Table (Operating), single pedestal AC or battery operated table, Orthopedic Systems, Inc., Union City, CA

    FDA Recall
    Terminated ·Mizuho Orthopedic Systems Inc·Product code LHN·February 28, 2007

    MEVION S250, System, Radiation Therapy, Charged-Particle, Medical used for Proton Radiation Therapy Product Usage: Proton Radiation Therapy

    FDA Recall
    Terminated ·Mevion Medical Systems, Inc.·Product code LHN·March 5, 2014

    Proteus 235, Proton Therapy System a medical device designed to produce and delivers a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.

    FDA Recall
    Terminated ·Product code LHN·November 17, 2017

    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

    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

    MEVION S250i

    FDA Recall
    Terminated ·Mevion Medical Systems, Inc.·Product code LHN·October 1, 2018

    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