Events

Retiro De Equipo (Recall) de Compact Medisorb Absorbers

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 GE Healthcare Clinical Systems.

¿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
    2006-10-03
  • 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-lots-d-absorbeurs-compact-medisorb-de-la-societe-ge-healthcare-clinical-systems
  • 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
    GE Healthcare Clinical Systems withdrew from the market on September 29, 2006 the batches of the references specified in the appendix of the medical device called Compact Medisorb Absorbers used on the ADU GE Healthcare anesthesia stations due to an increased internal resistance to the passage of gas that can be causing hypoventilation and hypoxia of the patient. No case has been reported in France .. The company has directly notified the recipients of the incriminated lots with the message attached (29/09/2006) (39 KB) validated by Afssaps .. This information is addressed to the directors of health establishments and the local correspondents of materiovigilance for dissemination, where appropriate to the services concerned. The relevant European competent authorities are informed of this measure by the manufacturer.

Device

Compact Medisorb Absorbers

Manufacturer

GE Healthcare Clinical Systems
  • Source
    LAANSM