Events

Recall of Device Recall Axiom Aristos FX

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
    49567
  • Event Risk Class
    Class 2
  • Event Number
    Z-0163-2009
  • Event Initiated Date
    2008-08-25
  • Event Date Posted
    2008-10-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-10-20
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73819
  • 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
    AXIOM ARISTOS FX (MULTI PURPOSE RADIOGRAPHY SYSTE - Product Code KPR
  • Reason
    Tube support arm or the detecting mounting hardware may become loose at the joint with the telescope.
  • Action
    Updated Instructions were issued in August 2008 (AX049/08/S) to Siemens Service Engineers to have them inspect and tighten any loose hardware on the affected systems.

Device

Device Recall Axiom Aristos FX
  • Model / Serial
    Serial numbers: 1059, 1078, 1083, 1088, 1093, 1109, and 1135.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution including states of CA, IN, KY, UT, VA and WI.
  • Product Description
    Axiom Aristos FX Multipurpose Radiography System, stationary X-Ray system, Model number: 7414803.
  • 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