Events

Alerte De Sécurité sur Diagnostic Imaging System

Selon National Institute of Drugs and Food Surveillance (INVIMA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Colombia qui a été fabriqué par Volcano Corporation.

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
  • ID de l'événement
    I1507-320
  • Numéro de l'événement
    2013EBC-0010738
  • Date
    2015-07-28
  • Pays de l'événement
    Colombia
  • Source de l'événement
    INVIMA
  • URL de la source de l'événement
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=175
  • Notes / Alertes
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
  • Notes supplémentaires dans les données

Device

Diagnostic Imaging System
  • Modèle / numéro de série
    S5 / SI software versions 3.3 and 3.4
  • Description du dispositif
    The VOLCANO system is used for the qualitative and quantitative evaluation of the vascular morphology in the coronary arteries and vessels of the peripheral vasculature. They are also indicated as a complement to conventional angiographic procedures to provide an image of the vessel lumen and option wall structures. CHROMAFLO is indicated for qualitative information about the blood flow of the coronary and peripheral vasculature; this information can complement other methods used to estimate perfusion and blood flow. The VH IVUS system is intended to be used in conjunction with imaging catheters during ultrasound imaging of the peripheral and coronary vasculature. The VOLCANO VH IVUS system aims to visualize, in a semi-automatic manner, characteristics of the limits and perform spectral analysis of RF ultrasound signals, which the user may wish to follow more closely during routine diagnostic ultrasound imaging exams. The pressure function is designed to be used in all blood vessels, including the coronary and peripheral arteries, to measure intravascular blood pressure during diagnostic angiography and / or intervention procedures. The VOLCANO S5I system provides diagnostic information when used in conjunction with catheters deformation of images during VOLCANO formation of ultrasonic images of the peripheral and coronary vasculature. It is intended to be used as an adjunct to conventional angiographic procedures or interventional therapies such as balloon angioplasty.
  • Manufacturer
    Volcano Corporation

Manufacturer

Volcano Corporation
  • Société-mère du fabricant (2017)
    Philips
  • Source
    NIDFSINVIMA