Events

Recall of Artis Q Systems with A100G generators

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-00303-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-03-02
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00303-1
  • 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
    In artis systems with a100g generators, a component can be affected by ageing, resulting in the failure of a module in the high-voltage generator. when the failure occurs, the system usually responds by providing emergency fluoroscopy. in the worst case, a spontaneous failure of the radiation generation function is conceivable. in the event of a spontaneous failure, it may be necessary to cancel or restart a clinical treatment or transfer it to a functioning system.
  • Action
    Siemens is advising users that potentially affected modules will be replaced. Users are further advised to implement standard emergency processes in the event of a system failure and to have these processes carefully prepared until the affected modules are replaced.

Device

Artis Q Systems with A100G generators
  • Model / Serial
    Artis Q Systems with A100G generators Catalogue Numbers: 10848353, 10848354, 10848355, 10848280, 10848281, 10848282, 10848283ARTG Number: 273952
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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