Retiro De Equipo (Recall) de CARTO® 3 Interface Cable

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 ETHICON SAS;CORDIS SAS;Johnson-Johnson.

¿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
    On 20/10/2010, the company: ETHICON SAS - CORDIS SAS Johnson-Johnson compagny, has withdrawn from the market all batches of the reference CR3410CT, of the medical device called "CARTO® interface cable", manufactured by: BIOSENCE WEBSTER Inc. Biosense Webster has determined that crossing the electrical signal in the cable can contribute to loss or distortion of surface ECG signals when using this cable. This is due to the presence of an electrical wire connecting two pins inside the connector of the interface cable with the CARTO® 3 system, which can cause a short circuit at the analog ground of the CARTO® 3 system. This short-circuit can also generate a low continuous electrical current when a CELSIUS ® DS catheter is connected. The company ETHICON SAS - CORDIS SAS has directly notified the recipients of the incriminated lots with the enclosed message validated by the Afssaps (22/10/2010) (160 ko) .. 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.