Events

Recall of Device Recall Artis Q

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
    75606
  • Event Risk Class
    Class 2
  • Event Number
    Z-0601-2017
  • Event Initiated Date
    2016-11-01
  • Event Date Posted
    2016-11-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-06-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=150895
  • 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 that the semi-automatic focus switch may not work as intended when pressing the footswitch multiple times.
  • Action
    Siemens mailed a Customer Safety Advisory Notice to affected customers to inform them of a corrective action they plan to perform to prevent a possible hazard to persons and equipment. The notice identified the associated risks, underlying issues, impact on system operation and actions to be taken.

Device

Device Recall Artis Q
  • Model / Serial
    Model Numbers: 10848280, 10848281, 10848282, 10848283, 10848353, 10848354, 10848355
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution.
  • Product Description
    Artis Q, Angiographic x-ray system || Product Usage: || The Artis systems are 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. Procedures that can be performed with the Artis zee / zeego and Q/ Q.zen include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. Artis zee / zeego and Q/ Q.zen can also support the acquisition of position triggered imaging for spatial data synthesis.
  • 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