Events

Retiro De Equipo (Recall) de HEARTSTART FRX AUTOMATED EXTERNAL DEFIBRILLATOR

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
    22538
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2010-05-20
  • 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
    Heartstart hs1 and frx automated external defibrillators (aeds) manufactured in march 2010 contain a relay that may not meet philips performance standards. possible contamination on the relay surface could compromise its performance over time and affect the aed's ability to make a therapy decision during use.

Device

HEARTSTART FRX AUTOMATED EXTERNAL DEFIBRILLATOR
  • Modelo / Serial
    Model Catalog: 861304 (Lot serial: B10C-02824); Model Catalog: 861304 (Lot serial: B10C-03286); Model Catalog: 861304 (Lot serial: B10C-02839); Model Catalog: M5066A (Lot serial: A10C-05759); Model Catalog: M5066A (Lot serial: A10C-05772); Model Catalog: M5066A (Lot serial: A10C-05751); Model Catalog: M5066A (Lot serial: A10C-05771); Model Catalog: M5066A (Lot serial: A10C-05778); Model Catalog: M5066A (Lot serial: A10C-05779); Model Catalog: M5066A (Lot serial: A10C-05752); Model Catalog: M5066A (Lot serial: A10C-06418); Model Catalog: M5066A (Lot serial: A10C-06407); Model Catalog: M5066A (Lot serial: A10C-05086); Model Catalog: M5066A (Lot serial: A10C-05081); Model Catalog: M5066A (Lot serial: A10C-05087); Model Catalog: M5066A (Lot serial: A10C-05941); Model Catalog: M5066A (Lot serial: A10C-06375)
  • Descripción del producto
    HEARTSTART FRX AED
  • Manufacturer
    PHILIPS ELECTRONICS LTD.

Manufacturer

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