Events

Recall of Artis Zeego Systems (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 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-2013-RN-00201-1
  • Event Risk Class
    Class III
  • Event Initiated Date
    2013-03-05
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00201-1
  • 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
    After a functional check of the brakes on the artis zeego system, there is a possibility of any output system information being overlaid and obscured with different system information. the overlaid information requests users to contact the service department.
  • Action
    If after carrying out the regular brake test, the system can persistently only be moved at a reduced speed, customers are requested to notify the customer care centre. A software update will be implemented to prohibit information from being overlaid.

Device

Artis Zeego Systems (Fluoroscopic angiographic x-ray system)
  • Model / Serial
    Artis Zeego Systems (Fluoroscopic angiographic x-ray system)ARTG Number: 102177
  • Manufacturer
    Siemens Ltd

Manufacturer

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