Events

Retiro De Equipo (Recall) de The Proton Therapy System Proteus 235 (brand names: Proteus Plus and Proteus ONE)

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
    80217
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-2284-2018
  • Fecha de inicio del evento
    2016-04-11
  • 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=164898
  • 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
    Iba is conducting a voluntary recall to address a pts (proton therapy system) software issue and to reduce the risk related to this issue.
  • Acción
    IBA mailed an Urgent Field Safety Notice to affected customers to inform them and prevent risk associated with this issue. IBA also recommends users always check for any discrepancy between the prescribed and delivered MUs on their clinical screen after an irradiation in which a pause occurred. IBA also recommends users always check for any discrepancy between the prescribed and delivered MUs on their clinical screen after an irradiation in which a pause occurred. A software upgrade will be deployed on impacted units to correct this issue.

Device

The Proton Therapy System Proteus 235 (brand names: Proteus Plus and Proteus ONE)
  • Modelo / Serial
    PAT.003 and PAT.006
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Units were distributed to Korea and Jacksonville, FL.
  • Descripción del producto
    The Proton Therapy System - Proteus 235 (brand names: Proteus Plus and Proteus ONE) || Proteus 235, Beam Management System (PBS)
  • 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