Events

Recall of Device Recall AXIOM ARTIS MODULAR ANGIOGRAPHIC SYSTEM

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Siemens Medical Solutions USA, 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
    49569
  • Event Risk Class
    Class 2
  • Event Number
    Z-0315-2009
  • Event Initiated Date
    2008-08-25
  • Event Date Posted
    2008-12-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-01-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73824
  • 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
    Angiographic x-ray system - Product Code IZI
  • Reason
    System may switch to emergency fluoroscopy mode.
  • Action
    A Customer Safety Advisory Letter dated 8/20/08 was issued with Update Instructions AX045/08/S. The letter informed the customer of the potential issue and provided instruction to avoid its occurrence. A software update (VB31E) was released to correct the issue.

Device

Device Recall AXIOM ARTIS MODULAR ANGIOGRAPHIC SYSTEM
  • Model / Serial
    Model number 7413078. Serial numbers: 46130, 46150, and 46205.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including states of AR, CA, CO, FL, IA, IL, IN, KS, KY, MI, NY, TX, VA, and WY.
  • Product Description
    AXIOM Artis System dTC using software version VB31D with 30x40 cm2 flat detectors. || ¿AXIOM Artis is a angiography system developed for single and biplane diagnostic imaging and interventional procedures.
  • Manufacturer
    Siemens Medical Solutions USA, Inc

Manufacturer

Siemens Medical Solutions USA, Inc
  • Manufacturer Address
    Siemens Medical Solutions USA, Inc, 51 Valley Stream Pkwy, Malvern PA 19355-1406
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    USFDA