Events

Safety Alert for System for Angiography AXIOM ARTIS

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Siemens Shenzhen Magnetic Resonance Ltd. || Siemens A.G..

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
    I1603-130
  • Event Number
    2008EBC-0001426
  • Date
    2016-03-31
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=149
  • 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 that in the angles near the collision zone of the arc, they can cause damage to the cable entry causing mechanical malfunctions, any attempt to resume operations after the detection of a fault (for example, a short circuit in the tube). x-rays) can cause the failure of a module in the high voltage generator, leading to potential adverse events on the patient or delays in the execution of procedures.

Device

System for Angiography AXIOM ARTIS

Manufacturer

Siemens Shenzhen Magnetic Resonance Ltd. || Siemens A.G.
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    NIDFSINVIMA