Events

Alerte De Sécurité sur digital mammography 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 Fujifilm Techno Products Co, Ltd || Fujifilm 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
    I1805-296
  • Numéro de l'événement
    2013EBC-0009847
  • Date
    2018-05-17
  • 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=47
  • 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

digital mammography system
  • Modèle / numéro de série
    AMULET - FDR-3500 DRLH, specific serials.
  • Description du dispositif
    FUJIFILM digital mammography system is indicated for obtaining digital mammographic radiographic images by means of low doses of RX in the following procedures, but without being limited to them: screening mammograms: diagnostic explorations for early detection of breast cancer, in women who do not have symptoms. Diagnostic mammograms: revisions to assist in the diagnosis of mammary diseases and evaluation of clinical abnormal pictures of screening mammograms in order to determine the cause of the conflicting area in the examination. Obtaining mammographic digital images, their processing, recording and post-production of mammographic images obtained with diagnostic purposes. Additionally, they can be used as support for the stereotactic guide or by three coordinates for the placement of mammary gland biopsy needles after the mammography, noting that this equipment or its accessories contain biopsy needles, only give the coordinates for their placement and allow their application in the site. chosen by the doctor through the FUJIFILM digital mammography system guide
  • Manufacturer
    Fujifilm Techno Products Co, Ltd || Fujifilm Corporation

Manufacturer

Fujifilm Techno Products Co, Ltd || Fujifilm Corporation