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 Stephanix.

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
    I1409-373
  • Event Number
    2014EBC-0011673
  • 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 has detected a potential risk when using fluoroscopy in multi-rad mode, where the fluoroscopy is not interrupted when the foot pedal is released, despite the release of the pedal with a non-defined exposure time, which can lead to the potential occurrence of adverse events. about patients or users.

Device

Digital X-ray system
  • Model / Serial
    D2RS, DX-D800, XCELLENCE DYNAMIC and D2-50RF
  • Product Description
    3-in-1 direct radiography system that offers real-time images for fluoroscopy, general radiography and
  • Manufacturer
    Stephanix

Manufacturer

Stephanix
  • Manufacturer Parent Company (2017)
    Stephanix
  • Source
    NIDFSINVIMA