Events

Retiro De Equipo (Recall) de PRESSURE kit intracranial pressure

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 SOPHYSA.

¿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
    2005-12-06
  • 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-de-kits-de-monitorage-de-pression-intracranienne-sophysa
  • 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    The SOPHYSA company has withdrawn from the market on December 5, 2005 all batches of the medical device called "PRESSURE PRESSURE kit intracranial pressure" PSO-PB, PSO-PT, PSO-VTJ following reports of materiovigilance of no clinical consequence that have highlighted, on some catheters, an anomaly of surface of the end of the sensor, being able to cause the display of outliers and / or an error message. The company warned directly the recipients of the batches incriminated to using the attached message (05/12/2005) (21 ko) validated by Afssaps. This information is intended for health facility directors and local correspondents for material safety for dissemination, if applicable. to the services concerned. The relevant European Competent Authorities are informed of this measure by the manufacturer.

Device

PRESSURE kit intracranial pressure
  • Modelo / Serial
  • Descripción del producto
    medical_device
  • Manufacturer
    SOPHYSA

Manufacturer

SOPHYSA
  • Source
    LAANSM