Retiro De Equipo (Recall) de Device Recall Powerheart AED, CardioVive AED, GE Responder AED, Nihon Kohden CardioLife AED

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Cardiac Science Corporation.

¿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 1
  • Número del evento
  • Fecha de inicio del evento
  • Fecha de publicación del evento
  • Estado del evento
  • País del evento
  • Fecha de finalización del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Automated external defibrillators (non-wearable) - Product Code MKJ
  • Causa
    The affected automated external defibrillators (aeds) contains a circuit board manufactured with a component that may fail unexpectedly due to a supplier manufacturing defect. if the component were to fail during a rescue attempt, the aed may not deliver defibrillation therapy.
  • Acción
    Cardiac Science sent an "URGENT-Voluntary Medical Device Recall" letter dated January 13, 2012 to all affected customers. The letter described the product, problem, and actions to be taken by the customers. Customers are advised to immediately return the device to the manufacturing location for repair. The affected devices will receive a hardware correction, and the same serial number device returned to the consignee in most cases. Customers in the US can call 1-888-402-2484 and customers outside the US can call 1-425-402-2482 or email at to arrange delivery of the shipping materials. Customers can also visit for more information about AEDs affected by this recall.


  • Modelo / Serial
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Worldwide distribution: USA (nationwide) and Puerto Rico; and to the following countries: Australia, Belgium, Brazil, Canada, China, Colombia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Hong Kong, Hungary, India, Indonesia, Israel, Italy, Jamaica, Japan, Korea, Kuwait, Malaysia, Maldives, Malta, Netherlands, New Zealand, Norway, Panama, Peru, Poland, Portugal, Qatar, Romania, Russia, Saint Lucia, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, United Arab Emirates, Ukraine, and United Kingdom.
  • Descripción del producto
    Powerheart G3 Automated External Defibrillators (Non-Wearable) and include the following models: Powerheart 9300A, 9300E, 9300P, 9390A, 9390E; CardioVive 92532, 92533; Nihon-Kohden 9200G, 9231; and GE Responder 2019198, 2023440 AEDs. || The Powerheart AED G3 is indicated for emergency treatment of victims exhibiting symptoms of sudden cardiac arrest who are unresponsive and not breathing. Post-resuscitation, if the victim is breathing, the AED should be left attached to allow for acquisition and detection of the ECG rhythm. If a shockable ventricular tachyarrhythmia recurs, the device will charge automatically and be able to deliver therapy. The device is intended to be used by personnel who have been trained it is operation. The user should be qualified by training in basic life support or other physician-authorized medical response.
  • Manufacturer


  • Dirección del fabricante
    Cardiac Science Corporation, 3303 Monte Villa Pkwy, Bothell WA 98021-8969
  • Empresa matriz del fabricante (2017)
  • Source