Events

Retiro De Equipo (Recall) de Microtome control console

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 ThermoFisher;Micromech Microtech France.

¿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
    2010-02-10
  • 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/rappel-du-pupitre-de-commande-des-microtomes-hm340e-et-hm355s-fabrique-par-la-societe-thermofisher-et-distribue-par-la-societe-microm-microtech-france
  • 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
    The Afssaps was informed on 25/01/2010 of a recall of the microtome control console HM340E and HM355S made by the manufacturer ThermoFisher and made in France by the Micromech Microtech France distributor on 15/01/2010. The users of this device concerned by this defect, in France, have received the attached letter (10/02/2010) (16 KB). The competent European authorities have been informed of this measure by the manufacturer. This information is intended for laboratory managers, directors of health establishments and local correspondents of reactive vigilance for distribution to the concerned biology departments.

Device

Microtome control console

Manufacturer

ThermoFisher;Micromech Microtech France