Events

Recall of Artis systems with SW version VC14J(X-ray system, diagnostic, fluoroscopic, angiographic, stationary, digital)

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-2015-RN-00612-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-07-08
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00612-1
  • 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
    Artis system has an x-ray locking function that prevents any accidental release of radiation. if the systems enters "bypass fluoro" mode while the x-ray locking function is active a system error can occur which makes it impossible to exit the locking function without restarting the system or resolving the cause of the "bypass fluoro".In the situation described, no radiation is possible and no fluoroscopic images can be acquired.
  • Action
    Siemens is developing a software patch to ensure that the Artis system automatically unlocks the radiation release in "Bypass Flouro" mode. This will ensure that imaging is possible in all cases. This action has been closed-out on 22/08/2016.

Device

Artis systems with SW version VC14J(X-ray system, diagnostic, fluoroscopic, angiographic, station...
  • Model / Serial
    Artis systems with SW version VC14J(X-ray system, diagnostic, fluoroscopic, angiographic, stationary, digital)Catalogue/Lot number – 10094137, 10094135, 10094141, 10094139, 10280959 with software version VC14JARTG Number: 102177
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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