Events

Recall of Artis zee and Artis Q systems with software version VD11C

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Siemens Healthcare Pty 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-2017-RN-01186-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-09-13
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01186-1
  • 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
    Siemens has identified an issue whereby in the application “dsa roadmap” the artis system's intended behaviour is to reject the stored vesselmap from previously acquired dsa if the patient table was moved during the roadmap workflow. in rare cases the system does not reject the dsa vesselmap and uses it for the further roadmap workflow steps. depending on the amount of table movement which was applied during the roadmap workflow, the dsa vesselmap may be overlaid as vessel tree at a position which does not fulfil siemens' requirements for accuracy.If the displacement of the vessel tree is large, it may be recognised by the user. however, if the displacement is either slight or at an unfavourable plane, the user may rely on incorrect visualisation of the catheter relative to the vesselmap.
  • Action
    1. The software in affected systems will be updated to correct the issue. 2. Users are to return the supplied acknowledgement form. 3. If the device is no longer in their possession forward the notice to the new owners. 4. Siemens will contact users to arrange a time to perform the software upgrade.

Device

Artis zee and Artis Q systems with software version VD11C
  • Model / Serial
    Artis zee and Artis Q systems with software version VD11CCatalogue/Lot Numbers: 10094137, 10848281, 10848282, 10848280, 10848283, 10094135, 10094139, 10848355, 10280959 and 10848353ARTG Number: 273952
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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