Events

Recall of Artis Systems with software versions VC14, VC21, VD10, VD11 and VE10(fluoroscopic angiographic digital 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-2017-RN-00228-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-02-14
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00228-1
  • 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 an issue with the current operating instructions. an existing system function is not fully described in the operating instructions, and this function may allow users to complete a treatment or diagnosis despite a defective focus.For artis systems with the specified software versions, a semi-automatic focus switch is implemented. interacting with a special type of defect due to wear in the foci "small" and "micro" (if present), this performs an automatic focus switch when the footswitch is pressed several times. this special system function is not fully described in the operating instructions currently available. if a focus (small/micro) develops a defect, an alternative focus can be selected by pressing the footswitch several times. this enables radiation to be generated once again so that the clinical treatment or diagnosis can be continued.
  • Action
    Siemens is providing supplement to the operating instructions that describes the corresponding "system messages" for the existing system function and explains how to use the function properly in the event of a fault. This action has been closed-out on 01/03/2018.

Device

Artis Systems with software versions VC14, VC21, VD10, VD11 and VE10(fluoroscopic angiographic di...
  • Model / Serial
    Artis Systems with software versions VC14, VC21, VD10, VD11 and VE10(fluoroscopic angiographic digital x-ray system)Catalogue Numbers: 10094135, 10094137, 10094139, 10094141, 10280959, 10848280, 10848281, 10848282, 10848283, 10848353, 10848355 ARTG Number: 273952
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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