Recall of Siemens Medical Axiom Artis System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Siemens Medical Systems Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
  • Event ID
  • Event Risk Class
    Class 2
  • Event Number
  • Event Initiated Date
  • Event Date Posted
  • Event Status
  • Event Country
  • Event Terminated Date
  • Event Source
  • Event Source URL
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    System, X-Ray, Angiographic - Product Code IZI
  • Reason
    Set delay time for contrast injection exceeds 10 seconds, radiation release button is blocked.
  • Action
    A Safety Advisory Letter was sent 7/23/2002 by Siemens Medical. The letter advised the technicians of the problem and Siemens would be coming out to do the software modificaitons.


  • Model / Serial
    Axiom Artis System:  Axiom Artis FC Model #5904433 --all serial #s  Axiom Artis FA Model #5904441 --all serial #s  Axiom Artis BC Model #5904649 --all serial #s  Axiom Artis BA Model #5904656 --all serial #s  Axiom Artis MP Model #5904466 -- all serial #s
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    The device was distributed to Hospitals nationwide.
  • Product Description
    Axiom Artis System, X-ray, Angiographic
  • Manufacturer


  • Manufacturer Address
    Siemens Medical Systems Inc, 186 Wood Ave So, Iselin NJ 08830
  • Source