Events

Safety Alert for Digital X-ray system

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Agfa Healthcare N.V..

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
    I1407-306
  • Event Number
    2011EBC-0007060
  • Date
    2014-07-30
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=199
  • 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 informs about the movement of asientoinesperado of the tube crane, although the team has security measures so that no movement can occur without user interaction, which can lead to potentially occuring adverse events on patients or users .

Device

Digital X-ray system
  • Model / Serial
    DX-D600
  • Product Description
    It allows to capture and process a wide range of studies with greater productivity thanks to the image quality, in an agile way it is passed to direct radiology, ideal for the study of external and internal patients, small hospitals and radiological imaging centers, emergency room, orthopedic centers and clinics private, as well as medical consultations allow to reduce the doses applied to the patient, thanks to cesium iodide technology, and does so for DR as for CR based on water technology is easily installed in limited spaces requires minimal training, provides a wide range of images in a short time
  • Manufacturer
    Agfa Healthcare N.V.

Manufacturer

Agfa Healthcare N.V.