Events

Recall of Artis zee and Artis zeego systems (software versions VC14 and VC21) with the A100 generator and specific manufacturing lots of 3 focal spot x-ray tube (fluoroscopic angiographic x-ray system)

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-2014-RN-01035-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-09-25
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01035-1
  • 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 a potential problem with the artis zee and artis zeego systems with the a100 generator and specific lots of a 3 focal spot x-ray tube. the “small focus” of a 3 focal spot x-ray tube may sporadically fail if the case grounding detaches from the focus head and overheating occurs. further radiation release won’t be possible. an ongoing procedure can be continued by using one of the two remaining focal spots ("large focus” or "micro focus") instead. to achieve that, the operator will need to switch over to the other focus, thus causing a short interruption of the ongoing procedure.
  • Action
    Siemens is implementing a software update that will protect the affected component from any damage in case the grounding detaches from the focus head. In case of such a potential failure, the system will automatically switch to the "Large Focus”. This action has been closed-out on 07/06/2016.

Device

Artis zee and Artis zeego systems (software versions VC14 and VC21) with the A100 generator and s...
  • Model / Serial
    Artis zee and Artis zeego systems (software versions VC14 and VC21) with the A100 generator and specific manufacturing lots of 3 focal spot x-ray tube (fluoroscopic angiographic x-ray system)ARTG number: 102177
  • Manufacturer
    Siemens Ltd

Manufacturer

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