Events

Recall of Automatic External Defibrillators

According to L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), this recall involved a device in France that was produced by Cardiac Science France.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Date
    2010-02-17
  • Event Country
    France
  • Event Source
    ANSM
  • Event Source URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/rappel-de-defibrillateurs-externes-automatiques-cardiac-science
  • Notes / Alerts
    French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), 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 France.
  • Extra notes in the data
  • Action
    On February 9, 2010, Afssaps was informed that the company Cardiac Science France has proceeded to the voluntary recall of automatic external defibrillators using the attached letter (17/02/2010) (48 KB). In fact, these automatic external defibrillators may fail, under certain conditions of use, and may therefore not deliver the treatment during an attempt at resuscitation.

Device

Automatic External Defibrillators

Manufacturer

Cardiac Science France
  • Source
    LAANSM