Events

Recall of Device Recall Artis One

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
    73606
  • Event Risk Class
    Class 2
  • Event Number
    Z-1282-2016
  • Event Initiated Date
    2016-03-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-11-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=144567
  • 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
    Interventional fluoroscopic x-ray system - Product Code OWB
  • Reason
    After importing segmentation results of the left atrium created on the artis one system, the possibility exists for the results to be mirrored to an electro-anatomical 3d mapping system, carto from biosense webster inc.
  • Action
    Siemens mailed an Important Customer Safety Notice to customers to inform them of the issue and the corrective actions they plan to take to address the problem. The letter stated that Siemens service organization will contact customers to arrange a date for the installation of the software update. Customers were instructed to call Siemens service organization for an appointment at 1-800-888-7436.

Device

Device Recall Artis One
  • Model / Serial
    Serial # 82010, material # 10848600
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution to Michigan only
  • Product Description
    Artis One, Interventional, Fluoroscopic, x-ray system || Artis one is an angiography system developed for diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the Artis One include cardiac angiography, neuro-angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures as well as procedures next to the table for patient extremities.
  • Manufacturer
    Siemens Medical Solutions USA, Inc

Manufacturer

Siemens Medical Solutions USA, Inc
  • Manufacturer Address
    Siemens Medical Solutions USA, Inc, 40 Liberty Blvd, Malvern PA 19355-1418
  • Manufacturer Parent Company (2017)
    Siemens Ag
  • Source
    USFDA