Events

Recall of Axiom Artis XRay System using software version VB11D or VB20B

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
    31761
  • Event Risk Class
    Class 2
  • Event Number
    Z-0796-05
  • Event Initiated Date
    2005-04-11
  • Event Date Posted
    2005-05-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-08-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=38458
  • 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
    Live display in exam room may sporadically stop working although the display in the control room remains fully operational.
  • Action
    The manufacturer provided a Customer Safety Advisory letter dated 3/24/05. The letter describes the problem and the interim work around. This letter was forward to the recalling firm''s direct accounts.

Device

Axiom Artis XRay System using software version VB11D or VB20B
  • Model / Serial
    model numbers 5904433, 5904441, 5904466, 7007755, 7008605, 7412807, 7413078, 7555365, 7555373, 7727717, and 7728350
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The product was shipped to hospitals in AL, AR, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, VA,WA,WI, and WV.
  • Product Description
    Axiom Artis X-Ray System using software version VB11D or VB20B
  • 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