Events

Recall of Device Recall Artis Systems with Software Artis VC20x/VC21A/VD10x

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
    64662
  • Event Risk Class
    Class 2
  • Event Number
    Z-0997-2013
  • Event Initiated Date
    2013-03-08
  • Event Date Posted
    2013-03-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-11-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=116731
  • 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
    The firm has become aware of a potential issue on artis systems with the software artis vc20x/vc21a/vd10x that have a dsa license installed. under certain preconditions, executing roadmap ogp (organ program) in the dsa overlay mode may lead to imprecise registration of the dsa mask image with the roadmap image displayed on the live monitor.
  • Action
    Siemens sent a Customer Safety Advisory Notice on March 8, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to pass the information on to all those who need to be aware of it and to instruct their personnel accordingly. Customers were asked to forward the safety information to other organizations that couald be affected by this action. For questions regarding this recall call 610-219-6300.

Device

Device Recall Artis Systems with Software Artis VC20x/VC21A/VD10x
  • Model / Serial
    Model numbers 10094135, 10094137, 10094139, 10094141 and 10280959.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution including AL, CA, CO, FL, IA, IL, IN, KY, MA, MD, ME, MI, MN, MO, NC, ND, NJ, NY, OH, PA, SC, TX, UT, VA, WA, and WI and to Puerto Rico.
  • Product Description
    Artis Systems with Software Artis VC20x/VC21A/VD10x that have a DSA license installed. || Angiographic 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 Pkwy, Malvern PA 19355
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    USFDA