Events

Recall of AXIOM Artis, Artis zee and Artis Q/Q.zen (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 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-2016-RN-00229-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-03-04
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00229-1
  • 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
    Due to a leak in the cooling system, fluids could seep into the equipment cabinet. this leak can occur sporadically in the affected systems. the issue was identified during regular field observations. in this case, there was a leak in the hose connectors. loss of coolant can result in cooling system failure, and in a worst case scenario, this leak can cause system failure.
  • Action
    Siemens are advising users that service personnel will be replacing the affected couplings in order to prevent the issue from occurring.

Device

AXIOM Artis, Artis zee and Artis Q/Q.zen (fluoroscopic angiographic x-ray system)
  • Model / Serial
    AXIOM Artis, Artis zee and Artis Q/Q.zen (fluoroscopic angiographic x-ray system)Catalogue Numbers: 7555365, 10094141, 10094139, 10094137, 10094135, 10280959, 10848281, 10848280, 10848282, 7413078, 7412807, 7008605, 10848355, 7728392, 7555357, 7727717ARTG Numbers: 102173 and 102177
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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