Events

Recall of Artis Zeego systems (Angiographic fluoroscopic digital diagnostic x-ray system) with software Artis VC20x/VC21A/VD10x that have a DSA license installed

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Siemens Ltd.

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
    RC-2013-RN-00212-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2013-03-08
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00212-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    There is 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 overlay of the dsa mask image with the roadmap image displayed on the live monitor.
  • Action
    End users are being requested to keep the system (stand or table) stationary between DSA taken and DSA used as mask when executing the OGP roadmap in the DSA overlay mode. A software update will be implemented to correct the issue.

Device

Artis Zeego systems (Angiographic fluoroscopic digital diagnostic x-ray system) with software Art...
  • Model / Serial
    Artis Zeego systems (Angiographic fluoroscopic digital diagnostic x-ray system) with software Artis VC20x/VC21A/VD10x that have a DSA license installedARTG Number: 102177
  • Product Classification
    Radiology Devices
  • Manufacturer
    Siemens Ltd

Manufacturer

Siemens Ltd
  • Manufacturer Parent Company (2017)
    Siemens AG
  • Source
    DHTGA