Events

Alerta De Seguridad para digital mammography system

Según National Institute of Drugs and Food Surveillance (INVIMA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Colombia que fue producido por Fujifilm Techno Products Co, Ltd || Fujifilm Corporation.

¿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
  • ID del evento
    I1805-296
  • Número del evento
    2013EBC-0009847
  • Fecha
    2018-05-17
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=47
  • Notas / Alertas
    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.
  • Notas adicionales en la data

Device

digital mammography system
  • Modelo / Serial
    AMULET - FDR-3500 DRLH, specific serials.
  • Descripción del producto
    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