Events

Alerte De Sécurité sur AFX Introducer System

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Endologix Inc.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Date
    2013-06-19
  • Date de publication de l'événement
    2013-06-19
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130619.html
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    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
  • Modèle / numéro de série
  • Classification du dispositif
    Cardiovascular Devices
  • Description du dispositif
    Medical Device Safety Alert: Endologix AFX Introducer System
  • Manufacturer
    Endologix Inc

Manufacturer

Endologix Inc