Events

Retiro De Equipo (Recall) de DOLPHIN inflation system

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 SEDAT.

¿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
    2006-11-02
  • 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/retrait-de-lot-d-un-systeme-d-inflation-dolphin-de-la-societe-sedat
  • 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    The SEDAT company has withdrawn from the market on October 27, 2006, the batches of the references specified in the annex of the medical device called "DOLPHIN inflation system" following a risk of blockage of the pressure gauge needle contained in this device, which would then cause a incorrect display of pressure. This system is used to inflate the balloon of an angioplasty catheter. The manufacturer has directly notified the recipients of the incriminated batches with the enclosed message (27/10/2006) (56 KB) validated by the This information is addressed to the directors of health establishments and local correspondents of materiovigilance for dissemination, where appropriate to the services concerned. The European competent authorities concerned are informed of this measure by Afssaps.

Device

DOLPHIN inflation system
  • Modelo / Serial
  • Descripción del producto
    medical_device
  • Manufacturer
    SEDAT

Manufacturer

SEDAT
  • Source
    LAANSM