Devices

Device Recall ProteusONE

  • Modelo / Serial
    SBF.101 (EU), SBF.105 (US)
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution: US (nationwide) to: MI only and country of: France.
  • Descripción del producto
    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.
  • Manufacturer
    Ion Beam Applications S.A.
  • 1 Event

Fabricante

Ion Beam Applications S.A.
  • Dirección del fabricante
    Ion Beam Applications S.A., Chemin du Cyclotron, 3, Louvain La Neuve Belgium
  • Empresa matriz del fabricante (2017)
    Ion Beam Applications SA
  • Source
    USFDA