Events

Safety Alert for digital mammography system AMULET

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by manufacturer #121.

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
    I1409-371
  • Event Number
    2013EBC-0009847
  • Date
    2014-09-17
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=196
  • 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
  • Reason
    The manufacturer reports that it has detected a possible failure in the compression tray which after the capture of an instant breast has been blocked and does not allow the decompression for the normal withdrawal of the patient, which may lead to the occurrence of potentially adverse events on the patient .

Device

digital mammography system AMULET
  • Model / Serial
  • Product Description
    The FUJIFILM digital mammography system is indicated for obtaining radiographic digital mammographic images by means of low doses of RX in the following procedures, but not limited to: screening mammograms: diagnostic tests 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 charts of screening mammograms in order to determine the cause of the controversial area in screening examination. Obtaining of digital mammographic images, their processing, recording and post-production of the mammographic images obtained with diagnostic purposes. Additionally, they can be used as a support for the stereotactic guide or for three coordinates for the placement of mammary gland biopsy needles after the mammography, noting that this equipment or its accessories do not contain biopsy needles, only give the coordinates for their placement and allow their application in the exact place chosen. by the doctor through the guide of the FUJIFILM digital mammography system.
  • Manufacturer
    manufacturer #121

Manufacturer

manufacturer #121
  • Manufacturer Parent Company (2017)
    Abbott Laboratories
  • Manufacturer comment
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    NIDFSINVIMA