Events

Retiro De Equipo (Recall) de Intracranial pressure kit

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
    2007-10-09
  • 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-kit-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
    On October 5, 2007, SOPHYSA withdrew from the market lots beginning with 7C or 6C of the following medical devices named. PRESSURE MONITORING PRESSURE MONITORING PRESSURE MONITORING KIT WITH BOLT REF. OSP-P. PRESSURE MONITORING KIT PRESSURE MONITORING PRESSURE INTRACRANIAL PARENCHYMATE TUNNELLIZABLE REF. OSP-P. PRESSIO® PRESSURE MONITORING KIT INTRACRANIAL VENTRICULAR TUNNELLIZABLE REF. PSO-VT,. manufactured by SOPHYSA, following a lack of electromagnetic insulation. The company SOPHYSA has directly notified the recipients of the incriminated lots with the message attached (09/10/2007) (219 KB) validated by Afssaps. This information is addressed to the directors and correspondents of materiovigilance for diffusion if necessary to the services concerned. The relevant European Competent Authorities are informed of this measure by the manufacturer.

Device

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

Manufacturer

SOPHYSA
  • Source
    LAANSM