Events

Recall of AXIOM Artis, Artis zee and Artis Q/Q.zen system (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-01004-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-07-28
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01004-1
  • 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 that contaminants in the form of biomass can develop in the cooling system of artis systems, which can result in damage to the pump system. the presence of contaminants in the tube cooling circuit could impair the performance of the pump. the tube assembly can become overheated so that no radiation can be released. there is a risk that an ongoing procedure cannot be continued, however, the probability of this occurring is unlikely.
  • Action
    Siemens is advising users that a technician will be installing an additional external filter in the cooling water circuit to prevent the failure of the pump system. A further correction will be implemented to prevent the development of biomass in the cooling circuit as a permanent correction. Siemens is advising that there is no requirement to re-examine patients.

Device

AXIOM Artis, Artis zee and Artis Q/Q.zen system (fluoroscopic angiographic x-ray system)
  • Model / Serial
    AXIOM Artis, Artis zee and Artis Q/Q.zen system (fluoroscopic angiographic x-ray system)Catalogue/Lot Numbers: 5904433, 5904649, 5904466, 5904441, 5904656, 7728350, 7007755, 7412807, 7727717, 7728392, 7413078, 5917054, 7555373, 7555357, 7008605, 7555365, 10502501, 10848280, 10848353, 10502502, 10848281, 10848354, 10502505, 10848283, 10502504, 10848282, 10848355, 10502507, 10094135, 10094142, 10094137, 10094143, 10094141, 10094139, 10280959ARTG Numbers: 102173, 27395, 102177
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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