Events

Recall of AED20 semi-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 Welch Allyn.

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
    2006-12-22
  • Event Country
    France
  • Event Source
    ANSM
  • Event Source URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/alerte-relative-a-des-defibrillateurs-externes-semi-automatiques-aed-20-de-la-societe-welch-allyn
  • 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
    A worldwide recall of AED20 semi-automatic external defibrillators has been implemented due to a risk of dysfunction preventing or delaying unacceptably the delivery of shock by the defibrillator, with a possible failure of the patient's resuscitation. In France, only 20 demonstration devices were concerned by this recall: after multiple searches, 2 devices numbers 205519 and 205520, were not found. As a result and in agreement with Afssaps, the company WELCH ALLYN asks all potential users of these devices, to check if they do not have these 2 serial numbers and to warn if necessary, the company WELCH ALLYN at +33 (0) 1 60 09 33 66. This information is addressed to the directors and pharmacists of health establishments, and to the local correspondents of materiovigilance for dissemination, where applicable to the services concerned. SDIS are also affected by this alert.

Device

AED20 semi-automatic external defibrillators
  • Model / Serial
  • Product Description
    medical_device
  • Manufacturer
    Welch Allyn

Manufacturer

Welch Allyn
  • Source
    LAANSM