Events

Alerta De Seguridad para AFX Introducer System

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Endologix Inc.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • Fecha
    2013-06-19
  • Fecha de publicación del evento
    2013-06-19
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130619.html
  • Notas / Alertas
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    Medical device safety alert: endologix afx introducer system the united states food and drug administration (fda) has issued a medical device safety alert concerning afx introducer system [model. no.: s17-45; lot no.: 1079840, 1079843, 1079844, 1079845], manufactured by endologix inc. according to the fda, the afx introducer system is intended to help introduce catheters and other medical devices into blood vessels during procedures with minimal blood loss. this product was recalled due to reports of the dilator breaking during procedures. use of this recalled product may cause serious adverse health consequences, including death. for details, please visit the following fda websites: http://www.Fda.Gov/safety/medwatch/safetyinformation/ safetyalertsforhumanmedicalproducts/ucm357563.Htm http://www.Fda.Gov/medicaldevices/safety/listofrecalls/ucm357544.Htm if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 19 june 2013.

Device

AFX Introducer System

Manufacturer

Endologix Inc