Events

Safety Alert for digital mammography system

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Fujifilm Techno Products Co, Ltd || Fujifilm Corporation.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    I1805-296
  • Event Number
    2013EBC-0009847
  • Date
    2018-05-17
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=47
  • Notes / Alerts
    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.
  • Extra notes in the data

Device

digital mammography system
  • Model / Serial
    AMULET - FDR-3500 DRLH, specific serials.
  • Product Description
    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