Events

Recall of Artis Systems with 19" Live Display(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-00924-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2016-07-11
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00924-1
  • 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 an error in the 19" live display, image reproduction may fail in the examination room. the loss of image can only occur immediately after system start-up. this failure does not occur during normal operation or when the live image is displayed. only systems which use a live display (reference dshc1914-dc with part number 10656055) in the examination room are affected. live displays with other part numbers are not affected by this issue.
  • Action
    Siemens is advising users that the system can continue to be used. A firmware upgrade will be implemented as a permanent correction.

Device

Artis Systems with 19" Live Display(fluoroscopic angiographic x-ray system)
  • Model / Serial
    Artis Systems with 19" Live Display(fluoroscopic angiographic x-ray system)Reference Number: DSHC1914-DCPart Number: 10656055ARTG Number: 273952
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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