Events

Recall of Artis systems with wireless footswitch Products Affected: AXIOM Artis FC, AXIOM Artis MP, AXIOM Artis dTA, AXIOM Artis dFC, AXIOM Artis dTC, AXIOM Artis dBA, AXIOM Artis dMP, AXIOM Artis dFC Magnetic Navigation, AXIOM Artis dBC, Artis zee floor, Artis zee ceiling, Artis zee multi-purpose, Artis zee biplane, Artis zeego, Artis Q floor, Artis Q ceiling, Artis Q biplane, Artis zeego.Q, Artis Q.zen floor, Artis Q.zen biplane, Artis one, ARTIS pheno

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-01240-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-09-27
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01240-1
  • 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 is advising that the wireless foot switch can fail due to impacts by external factors, such as electrostatic discharge that exceeds a certain intensity. if a wireless foot switch fails, it will no longer be possible to use it to release radiation, however it will still be possible to trigger exposures if a wired foot switch or hand switch is present. fluoroscopy with the hand switch is not possible.This may result in a situation where it is necessary to cancel or restart clinical treatment or transfer the treatment to a functioning system.
  • Action
    Siemens is advising users that the affected control assembly will be replaced with a new version to correct the issue.

Device

Artis systems with wireless footswitch Products Affected: AXIOM Artis FC, AXIOM Artis MP, AXIOM A...
  • Model / Serial
    Artis systems with wireless footswitchProducts Affected: AXIOM Artis FC, AXIOM Artis MP, AXIOM Artis dTA, AXIOM Artis dFC, AXIOM Artis dTC, AXIOM Artis dBA, AXIOM Artis dMP, AXIOM Artis dFC Magnetic Navigation, AXIOM Artis dBC, Artis zee floor, Artis zee ceiling, Artis zee multi-purpose, Artis zee biplane, Artis zeego, Artis Q floor, Artis Q ceiling, Artis Q biplane, Artis zeego.Q, Artis Q.zen floor, Artis Q.zen biplane, Artis one, ARTIS phenoARTG Numbers: 273952 and 222194
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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