Events

Retiro De Equipo (Recall) de Device Recall ProteusPLUS and ProteusONE

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Ion Beam Applications S.A..

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    80298
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2424-2018
  • Fecha de inicio del evento
    2018-05-16
  • Fecha de publicación del evento
    2018-06-20
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=165077
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    System, radiation therapy, charged-particle, medical - Product Code LHN
  • Causa
    Correction vector confirmation message is lost if access point is changed after sending the correction vector. as a result, the patient will be treated in the setup position or treatment position instead of the corrected position.
  • Acción
    On May 18, 2018 IBA issued URGENT FIELD SAFETY NOTICES to their customers. Customers were advised to take the following actions: It is recommended to ensure that the correction vector confirmation message appears on the expected access point. When the correction vector is applied (if deemed necessary1), ensure that the Patient Positioning System GoTo the corrected position for treatment before starting irradiation: - verify on adaPTdeliver screen that the corrected target position is selected before engaging the movement. - verify on adaPTdeliver screen that the corrected target position appears on the screen after the movement. Moreover, as advised in the Proton Therapy System Clinical User Guide, it is recommended to verify the patient position after each correction vector application. A software update will be deployed on all affected sites by July 2018. Customers with questions may email: vigiliance@iba-group.com

Device

Device Recall ProteusPLUS and ProteusONE
  • Modelo / Serial
    Serial Numbers: SAT.122 (EU) SAT.132 (EU) SAT.133 (US)
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US Nationwide in the states of FL and the countries of Sweden, The Netherlands
  • Descripción del producto
    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.

Manufacturer

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