Events

Retiro De Equipo (Recall) de ALLURA XPER FD20/15

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
    64935
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2017-08-16
  • 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 discovered through trend analysis an increase in the failure rate of certain anode drive units (adus) used in these products. early life failure of the adus only occurs when the hospital mains provide 480v to the system. when the adu fails the x-ray performance of the system is reduced to emergency fluoroscopy. exposure will not be possible and image quality is reduced.

Device

ALLURA XPER FD20/15
  • Modelo / Serial
    Model Catalog: 722058 (Lot serial: 110 / 65331325); Model Catalog: 722035 (Lot serial: 111 / 67475814); Model Catalog: 722035 (Lot serial: 128 / 68199187); Model Catalog: 722038 (Lot serial: 102 / 65331332); Model Catalog: 722028 (Lot serial: 1261 / 70828850); Model Catalog: 722028 (Lot serial: 1056 / 69430666); Model Catalog: 722028 (Lot serial: 1039 / 69397862); Model Catalog: 722028 (Lot serial: 942 / 68733944); Model Catalog: 722028 (Lot serial: 663 / 66650325); Model Catalog: 722028 (Lot serial: 878 / 68280389); Model Catalog: 722028 (Lot serial: 763 / 67493645); Model Catalog: 722028 (Lot serial: 758 / 67476532); Model Catalog: 722028 (Lot serial: 742 / 67341881); Model Catalog: 722028 (Lot serial: 905 / 68002624); Model Catalog: 722026 (Lot serial: 759 / 69723007); Model Catalog: 722026 (Lot serial: 866 / 67402179); Model Catalog: 722026 (Lot serial: 830 / 70417112); Model Catalog: 722026 (Lot serial: 271 / 64615994); Model Catalog: 722026 (Lot serial: 707 / 69150243); Model Catalog: 722026 (Lot seria
  • Descripción del producto
    ALLURA XPER FD20/15;ALLURA XPER FD20 OR TABLE (PRODUCT OF ALLURACLARITY FAMILY);ALLURA XPER FD20/20 (PRODUCT OF ALLURACLARITY FAMILY);ALLURA XPER FD20 (PRODUCT OF ALLURACLARITY FAMILY);ALLURA XPER FD10 (PRODUCT OF ALLURACLARITY FAMILY)
  • Manufacturer
    PHILIPS ELECTRONICS LTD.

Manufacturer

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