Events

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
    Recall
  • Event ID
    25073
  • Event Risk Class
    Class 2
  • Event Number
    Z-0347-03
  • Event Initiated Date
    2002-08-05
  • Event Date Posted
    2002-12-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-10-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25111
  • 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.

Device

Siemens Medical Axiom Artis System
  • 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
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The device was distributed to Hospitals nationwide.
  • Product Description
    Axiom Artis System, X-ray, Angiographic
  • Manufacturer
    Siemens Medical Systems Inc

Manufacturer

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