Events

Recall of Device Recall Axiom Artis

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
    29327
  • Event Risk Class
    Class 2
  • Event Number
    Z-1108-04
  • Event Initiated Date
    2004-06-02
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-10-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=33553
  • 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
    Error appears in the automap function, module 2, when peristeeping or perivision is activated simultaneously that causes system to crash.
  • Action
    The recalling firm sent recall letter to their customers informing them of the software problem. The customers were informed that a Siemens Service Representative will visit each location to deactivate Module 2 of the AUTOMAP function per Update AX023/04S.

Device

Device Recall Axiom Artis
  • Model / Serial
    Model Numbers:  AXIOM Artis FC 5904433 AXIOM Artis BC 5904649 AXIOM Artis MP 5904466 AXIOM Artis FA 5904441 AXIOM Artis BA 5904656 AXIOM Artis TA 7007755  AXIOM Artis FC: 10050; 10052; 10055; 10064; 10072; 10086; 10094; 10124; 10148; 10151; 10153; 10176; 10177; 10182; 10198; 10217; 10228; 10237; 10240; 10243; 10249; 10251; 10253; 10266; 10284; 10298; 10307; 10326; 10335; 10338; 10348; 10364; 10365;  10367; 10369  AXIOM Artis BC: 14007  AXIOM Artis MP: 20022; 20024; 20032; 20036; 20045; 20048; 20070; 20078; 20082; 20090; 20094; 20107; 20110; 20111; 20155; 20169; 20177; 20190; 20199; 20203; 20205
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The recalled product has been distributed throughout the United States, such as: AK, AL, AZ, CA, DC, FL, GA, IA, IL, IN, KY, LA, MI, MN, MO, MS, NC, NJ, NY, OH, OK, PA, SC, TN, TX, VA, WA, WI,
  • Product Description
    SIEMENS AXIOM Artis - AUTOMAP FUNCTION
  • 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