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-2014-RN-01303-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-12-12
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01303-1
  • 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
    A cable inside the c-arm of systems affected may have been routed in an inappropriate manner and there is a potential that with increased wear a cable inside the c-arm may break. a cable break will result in restricted functionality and even system failure.
  • Action
    Siemens is replacing the affected cable harness with a modified version in addition to re-routing the cables to prevent wear. This action has been closed-out on 01/03/2016.

Device

Artis Zeego Systems (Fluoroscopic angiographic x-ray system)
  • Model / Serial
    Artis Zeego Systems (Fluoroscopic angiographic x-ray system)C-arm Serial Number Range: 1000 to 1599ARTG Number: 102177
  • Manufacturer
    Siemens Ltd

Manufacturer

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