Events

Recall of Axiom Artis MP XRay 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
    31647
  • Event Risk Class
    Class 2
  • Event Number
    Z-0818-05
  • Event Initiated Date
    2005-04-01
  • Event Date Posted
    2005-05-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-08-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=38293
  • 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
    Potential problem with the fluoroscopy switch on the power grip.
  • Action
    The recalling firm''s Customer Service Engineers are visiting each account to correct/replace the Power Grip button.

Device

Axiom Artis MP XRay System
  • Model / Serial
    Serial numbers 10, 1021, 1025, 1026, 1027, 1043, 1044, 1048, 1050, 1052, 1056, 1065, 1067, 1069, 1080, 1082, 1083, 1085, 1087, 1089, and 1097.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The products were shipped to hospitals in AL, AZ, DC, DE, IA, MI, NC, NE, PA, RI, TX, WA, and WI.
  • Product Description
    Axiom Artis MP X-Ray System
  • 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