Events

Retiro De Equipo (Recall) de AED20 semi-automatic external defibrillators

Según L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en France que fue producido por Welch Allyn.

¿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
  • Fecha
    2006-12-22
  • País del evento
    France
  • Fuente del evento
    ANSM
  • URL de la fuente del evento
    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
  • Notas / Alertas
    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.
  • Notas adicionales en la data
  • Acción
    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
  • Modelo / Serial
  • Descripción del producto
    medical_device
  • Manufacturer
    Welch Allyn

Manufacturer

Welch Allyn
  • Source
    LAANSM