Retiro De Equipo (Recall) de Acrobat Stabilizer-Vacuum 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 Edwards Lifesciences.

¿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
  • Fecha
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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    The company Edwards Lifesciences has withdrawn from the market on December 15, 2006 the batches between 4120181 and 6100281 of the medical device called "Acrobat stabilizer-vacuum system" references OM9000S, OM9100S and XO49000S manufactured by GUIDANT-BOSTON Scientific Cardiac Surgery following a highlighting Vacuum leakage may result in partial loss of suction force during 2-year aging tests. As a result, the expiration is changed from 2 years to one year .. This device is used in cardiac surgery. The company has directly notified the recipients of the incriminated lots with the message attached (18/12/2006) (35 ko) validated by the Afssaps. This information is addressed to the directors of health establishments and the local correspondents of materiovigilance for diffusion, if necessary with the services concerned .. The competent European authorities concerned are informed of this measure by the manufacturer.