Events

Retiro De Equipo (Recall) de ALLURA XPER FD20/10 SYSTEM - MAIN UNIT

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por PHILIPS ELECTRONICS LTD..

¿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
    31685
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2015-09-22
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Notas adicionales en la data
  • Causa
    Philips has become aware that memory problems on the embedded technology extended (etx)-module in the system interface board (sib) box cause intermittent failures. the sibbox plays a role in starting and stopping and controlling the image functionality. although highly intermittently the failure can occur both during startup as during system use. the failure does not affect an active x-ray run and the run can be finished. however no new run can be started until the system is rebooted. as such the failure has no impact on the critical moment in a critical procedure.

Device

ALLURA XPER FD20/10 SYSTEM - MAIN UNIT
  • Modelo / Serial
    Model Catalog: ALLURA XPER FD20/10 (Lot serial: ALL); Model Catalog: ALLURA XPER FD10/10 (Lot serial: ALL); Model Catalog: 000454 (Lot serial: ALL); Model Catalog: ALLURA XPER FD20 (Lot serial: ALL); Model Catalog: ALLURA XPER FD20/20 (Lot serial: ALL); Model Catalog: ALLURA XPER FD10 (Lot serial: ALL)
  • Descripción del producto
    ALLURA XPER FD20/10 SYSTEM - MAIN UNIT
  • Manufacturer
    PHILIPS ELECTRONICS LTD.

Manufacturer

PHILIPS ELECTRONICS LTD.
  • Dirección del fabricante
    MARKHAM
  • Empresa matriz del fabricante (2017)
    Philips
  • Source
    HC