Events

Retiro De Equipo (Recall) de INGENUITY 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
    15694
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2016-08-29
  • 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 while performing high resolution head scans the reconstructed images may exhibit degraded image quality manifested as: - non uniformity of the image - ct number shift greater than 5 hounsfield units - reduction in gray/white matter differentiation the issue is most severe in the high resolution mode. philips provides factory reference pediatric scan protocols which are set to high resolution by default. adult head scans have a factory reference protocol that defaults to standard resolution which does not experience the issue.

Device

INGENUITY CT SYSTEM
  • Modelo / Serial
    Model Catalog: 728323 (Lot serial: 32021); Model Catalog: 728326 (Lot serial: 320123); Model Catalog: 728323 (Lot serial: 320123); Model Catalog: 728326 (Lot serial: 320227); Model Catalog: 728326 (Lot serial: 32021); Model Catalog: 728326 (Lot serial: 30003); Model Catalog: 728323 (Lot serial: 30003); Model Catalog: 728326 (Lot serial: 30004); Model Catalog: 728323 (Lot serial: 30004); Model Catalog: 728323 (Lot serial: 320227); Model Catalog: 4550 110 09021 (Lot serial: 10213); Model Catalog: 4550 110 09021 (Lot serial: 9074); Model Catalog: 4550 110 09021 (Lot serial: 9920); Model Catalog: 4550 110 09021 (Lot serial: 9923)
  • Descripción del producto
    INGENUITY CT SYSTEM;BRILLIANCE 40/64 SLICE CT SYSTEM
  • Manufacturer
    PHILIPS ELECTRONICS LTD.

Manufacturer

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