Events

Retiro De Equipo (Recall) de Proton beam therapy system

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 Hitachi America, Ltd., Power Systems Division.

¿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
    71056
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1838-2015
  • Fecha de inicio del evento
    2015-04-21
  • Fecha de publicación del evento
    2015-07-18
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-03-24
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=135952
  • 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
    At a probeat iii site installed in japan, the operator of the system found that the radiation was delivered inconsistent with the treatment plan and stopped the irradiation. the irradiation control system may be potentially affected when rebooting a part of the control system.
  • Acción
    The recalling firm notified the one consignee about the incident that occurred in Japan on 4/7/15, then gave them an update on 4/13/15 and 4/21/15. The written notification had details for the consignee on how to prevent the device from malfunctioning. The recalling firm also had held conversations with the consignee to discuss the issue and revised work instructions via telephone conference and on site Hitachi personnel.

Device

Proton beam therapy system
  • Modelo / Serial
    No serial number or lot code. Each system is designed for a specific facility therefore no codes are needed for traceability
  • Clasificación del producto
    Radiology Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distribution in US (Texas) and Japan
  • Descripción del producto
    PROBEAT WITH DISCRETE SPOT SCANNING SYSTEM || Product Usage: || Hitachi PROBEAT with DSSS 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.
  • Manufacturer
    Hitachi America, Ltd., Power Systems Division

Manufacturer

Hitachi America, Ltd., Power Systems Division
  • Dirección del fabricante
    Hitachi America, Ltd., Power Systems Division, 1840 Old Spanish Trl, Houston TX 77054-2002
  • Empresa matriz del fabricante (2017)
    Hitachi Ltd
  • Source
    USFDA