Events

Recall of Device Recall Artis Q systems

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
    71711
  • Event Risk Class
    Class 2
  • Event Number
    Z-2341-2015
  • Event Initiated Date
    2015-06-29
  • Event Date Posted
    2015-08-05
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-12-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139160
  • 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
    The possibility exists for a large amount of liquid to seep through the top cover of the table and penetrate the components inside the table. if this occurs, table movements may no longer be possible. no injuries reported.
  • Action
    A customer safety notice, dated June 29, 2015, was sent to direct accounts to alert them about the issue and that Siemens' service organization will be contacting them to perform the corrective action.

Device

Device Recall Artis Q systems
  • Model / Serial
    Model Number of device: 10848282 10848281 10848355 10848354 serial numbers: 121006 121013 109016 121011 123008 123003 123011 121014 109011 121004 121018 121036 121012 109015 109009 121019 121010 121015 121016 109007 111000 121020 121009 121056 121057 109021 121008 109020 109027 109010 123010 121041
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide
  • Product Description
    Artis Q systems; || dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed include cardiac angiography, neuro angiography, general angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures.
  • 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