Events

Retiro De Equipo (Recall) de BRILLIANCE 40/64 SLICE CT SYSTEM

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
    42652
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2016-05-02
  • 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
    Imr cardiac - irregular appearance of contrast in vessels missing image annotation's in cct halo artifacts incorrect z annotation on plan box for coronal/sagittal surviews unintended change of acquisition timing on scan ruler bolus tracker does not trigger as expected system unresponsive when paused system becomes unresponsive during timed scan unplanned results during multi-phase pulmo series may cause a system crash communication errors between host computer & gantry incorrect phase tolerance for cardiac step & shoot error when auto roi placement outside patient anatomy no "go" when hr outside of acceptable range console unresponsive when gantry cancels scan unable to match z locations on prescan and 4d ct scan pin wheel artifact using 0.67mm slice width tracker scan halted with fdom. (please contact manufacturer for details regarding reasons for recall).

Device

BRILLIANCE 40/64 SLICE CT SYSTEM
  • Modelo / Serial
    Model Catalog: 4550 110 09021 (Lot serial: ALL); Model Catalog: 728311 (Lot serial: ALL); Model Catalog: 728326 (Lot serial: ALL); Model Catalog: 728323 (Lot serial: ALL); Model Catalog: 728306 (Lot serial: ALL)
  • Descripción del producto
    BRILLIANCE 40/64 SLICE CT SYSTEM;BRILLIANCE ICT SP SYSTEM-MAIN;INGENUITY CT SYSTEM;BRILLIANCE ICT SYSTEM-SYSTEM
  • Manufacturer
    PHILIPS ELECTRONICS LTD.

Manufacturer

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