Devices

Device Recall ProteusPlus

  • Modèle / numéro de série
    Serial Numbers: PAT.006, PAT.108, PAT.112, PAT.113, SAT.116, PAT.003
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Distributed to FL, VA, IL, NJ, WA and South Korea
  • Description du dispositif
    Proteus 235, Proton Therapy System || Product Usage: || The Proton Therapy System - Proteus 235 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

Fabricant

Ion Beam Applications S.A.
  • Adresse du fabricant
    Ion Beam Applications S.A., Chemin du Cyclotron, 3, Louvain La Neuve Belgium
  • Société-mère du fabricant (2017)
    Ion Beam Applications SA
  • Source
    USFDA

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Device Recall ProteusPLUS
  • Modèle / numéro de série
    Serial numbers: PAT.000, PAT.001, PAT.003, PAT.006, PAT.108, PAT.111, SAT.119, SAT.120
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Distributed in MA, FL, VA, and TN. China, South Korea, France and Germany
  • Description du dispositif
    Proteus 235
  • Manufacturer
    Ion Beam Applications S.A.
Device Recall ProteusPLUS and ProteusONE
  • Modèle / numéro de série
    PAT.000 (US), PAT.001 (CN), PAT.003 (KR), PAT.006 (US), PAT.107 (EU), PAT.108 (US), PAT.109 (US), PAT.110 (US), PAT.111 (EU), PAT.112 (US), PAT.113 (US), PAT.114 (EU), PAT.115 (EU), SAT.116 (US), SAT.117 (EU), SAT.119 (US), SAT.120 (EU), SAT.122 (EU), SAT.123 (US), SAT.126 (US), SAT.132 (EU), SAT.133 (US), SBF.101 (EU), SBF.105 (US)
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationally
  • Description du dispositif
    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.
  • Manufacturer
    Ion Beam Applications S.A.
Device Recall ProteusPLUS
  • Modèle / numéro de série
    PAT.000 (US), PAT.003 (KR), PAT.006 (US), PAT.107 (EU), PAT.108 (US), PAT.109 (US), PAT.110 (US), SAT.119 (US).
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Distribution to the states of : MA, FL, VA, PA, OK, TN
  • Description du dispositif
    Proteus 235, Uniform and Pencil Beam Scanning || 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.
Device Recall ProteusPLUS and ProteusONE
  • Modèle / numéro de série
    Serial Numbers: SAT.122 (EU) SAT.132 (EU) SAT.133 (US)
  • Classification du dispositif
    Radiology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US Nationwide in the states of FL and the countries of Sweden, The Netherlands
  • Description du dispositif
    Proteus 235, Version PTS-11.0.1.2 and PTS-11.0.2 || Product Usage: || A 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.
  • Manufacturer
    Ion Beam Applications S.A.