Events

Recall of Artis zee and Artis zeego systems

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-00775-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-07-11
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00775-1
  • 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
    Under certain circumstances the release of radiation can become blocked unnecessarily. the system to block the release of radiation after the system has booted up if an error occurs with the large display. the radiation block remains even if the error that triggered the block was a temporary one or has been cleared.
  • Action
    Siemens is providing a software patch to correct this issue. The software limits the blockage of radiation release to three seconds and the screen in the control room displays the message "No Xray, try again". After the next attempt, radiation can then be released without restriction. This action has been closed-out on 02/06/2016.

Device

Artis zee and Artis zeego systems
  • Model / Serial
    Artis zee and Artis zeego systemsMultiple material numbers with software VC21B and Large DisplayARTG Number: 102177
  • Manufacturer
    Siemens Ltd

Manufacturer

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