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
  • Numéro de l'événement
    2013EBC-0009847
  • Date
    2017-10-04
  • 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=69
  • 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 MS-2500/2000 and FDR MS-3500, serial 16940043,
  • Description du dispositif
    The FUJIFILM digital mammography system is indicated for obtaining digital radiographic mammographic 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 abnormal clinical pictures of exploration mammograms in order to determine the cause of the controversial area in the exploration examination. Obtaining digital mammographic images, their processing, recording and post-production. of the mammographic images obtained for diagnostic purposes. Additionally, they can be used as a support for the stereotaxic guide or for 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 its placement and allow its application in the exact place 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