Events

Recall of Device Recall Artis Q/ Q.Zen biplane, Artis Zee biplane

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
    79039
  • Event Risk Class
    Class 2
  • Event Number
    Z-0508-2018
  • Event Initiated Date
    2017-08-24
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161222
  • 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
    Within a specific number of artis zee biplane and artis q biplane systems, a connection in the ceiling mount consisting of 12 screws may not have been attached and fastened according to quality standards. a quality inspection will be initiated to ensure all screws in the rotation unit meet quality standards.
  • Action
    Siemens sent an Urgent: Medical Device Correction letter dated August 24, 2017 to all affected customers. The letter identified the affected product, problem and actions to be taken. A local management or dispatch will schedule for an inspection to correct the issue. For questions please call 1-800-888-7436

Device

Device Recall Artis Q/ Q.Zen biplane, Artis Zee biplane
  • Model / Serial
    10094141 10848282 10848355
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution
  • Product Description
    AArtis Q/ Q.Zen biplane || Artis zee biplane || Product Usage: Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
  • 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