Events

Recall of Artis zee, Artis Q and Artis Q.zen systems with software version VD11B

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-01637-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2016-12-20
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01637-1
  • 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
    During regular field observations siemens have identified a software issue with two possible, mutually independent causes of a system defect, these are as follows:1. in artis systems with a100plus or a100g generators, an attempt to resume operation following detection of a fault (such as a short circuit in the x-ray tube) can result in the failure of a module in the high-voltage generator; and2. for biplane systems delivered with software version vd11b since april of this year, software problems in conjunction with the graphics card may in rare cases result in the loss of image display in the examination room.Siemens advises they do not consider it necessary to re-examine any patients in this case and that this is a possible hardware defect that has no influence on the treatment of patients.A system software update will implement additional protective mechanisms for the generator and correct the software problem.
  • Action
    Siemens will be contacting affected users to arrange a date to perform a system software update, which will implement additional protective mechanisms for the generator and correct the software problem.

Device

Artis zee, Artis Q and Artis Q.zen systems with software version VD11B
  • Model / Serial
    Artis zee, Artis Q and Artis Q.zen systems with software version VD11BCatalogue/Lot Numbers: 10848281, 10848355, 10848282, 10848280, 10094139, 10094137, 10848353ARTG Number: 273952
  • Product Classification
    Radiology Devices
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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