Events

Recall of Axiom Aristos 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
    26596
  • Event Risk Class
    Class 2
  • Event Number
    Z-0984-03
  • Event Initiated Date
    2003-04-19
  • Event Date Posted
    2003-07-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-08-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=27955
  • 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, Stationary - Product Code KPR
  • Reason
    Software malfunction. may indicate that the image is flipped when it is not.
  • Action
    The recalling firm issued recall letters dated 4/19/03 to their accounts along with instructions for handling images that have already been archived.

Device

Axiom Aristos XRay System
  • Model / Serial
    part numbers 5895003 and 7414803. serial numbers 01001, 01170, 01219, 01221, and 01030.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The units were shipped to medical facilities nationwide.
  • Product Description
    Axiom Aristos 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 Parkway, Malvern PA 19355
  • Source
    USFDA