Events

Recall of Axiom Artis and Artis Zee Systems with hand switch (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-00648-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-06-17
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00648-1
  • 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
    A problem may occur if the connection between cable connection and hand switch is contaminated with a large amount of fluid. in a worst case situation, uncontrolled release of a x-ray image may happen. the system terminates uncontrolled x-ray after a short period.
  • Action
    Siemens service personnel will contact affected customers to organise for the removal of the cable extension. The hand switch will be directly connected to the patient table preventing the issue from occurring.

Device

Axiom Artis and Artis Zee Systems with hand switch (Fluoroscopic angiographic X-ray system)
  • Model / Serial
    Axiom Artis and Artis Zee Systems with hand switch (Fluoroscopic angiographic X-ray system)Hand Switch Material Number: 3771750 ARTG Numbers: 102173 and 102177
  • Manufacturer
    Siemens Ltd

Manufacturer

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