Retiro De Equipo (Recall) de Philips HeartStart Home and OnSite (HS1) Automated External Defibrillators

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Philips Electronics Australia 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
  • ID del evento
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    Phillips has determined in a limited number of heartstart home and onsite (hs1) aeds, one or both contact pins may be contaminated by residue from the soldering process. this contamination could prevent an adequate connection between the pads cartridge and the aed resulting in the device being unable to deliver therapy.
  • Acción
    End users are requested to identify if they have an affected AED and contact Philips immediately. Philips is advising that if no alternative is available that AEDs should be kept in service until replacement unit can be supplied. This action has been closed-out on 18/02/2016.


  • Modelo / Serial
    Philips HeartStart Home and OnSite (HS1) Automated External DefibrillatorsModel numbers: M5066A and M5068ASerial number range : A13G-00047 to A136-006576ARTG number: 92346
  • Clasificación del producto
  • Manufacturer


  • Empresa matriz del fabricante (2017)
  • Source