Events

Recall of Axiom Artis dTC

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
    49584
  • Event Risk Class
    Class 2
  • Event Number
    Z-0123-2009
  • Event Initiated Date
    2008-09-02
  • Event Date Posted
    2008-11-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-10-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73843
  • 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
    Angiography X-Ray - Product Code IZI
  • Reason
    Incorrect contour finding: image may be calibrated to the wrong size catheter.
  • Action
    Siemens issued a Customer Safety Advisory Notice dated 8/29/08 to inform customers of the potential issue. The recalling firm issued Update Instructions AX040/08/S to the service engineers which provides information to fix the problem.

Device

Axiom Artis dTC
  • Model / Serial
    Model number 7413078. Serial numbers: 46129, 46189, 46190, 46206, 46208, 46209, 46210, 46211, 46212, 46213, 46214, 46215, 46216, 46217, 46218, 46219, 46220, 46221, 46222, 46223, 46224, 46225, 46226, 46227, 46228, 46229, 46230, 46231, 46232, 46233, 46234, 46235, 46236, 46237, 46238, 46239, 46241, 46242, 46243, 46244, 46245, 46246, 46248, 46249, 46250, 46251, 46253, 46254, and 46255.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide.
  • Product Description
    Axiom Artis dTC, Axiom Artis Modular Angiography X-Ray System, Model number 7413078.
  • 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
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    USFDA