Events

Recall of Artis zeego systems with a C - arm (Fluoroscopic X-ray 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-01112-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-10-17
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01112-1
  • 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
    Siemens have identified that a cable inside the c - arm of affected systems may have been routed in an inappropriate manner and there is a potential that with increase wear the cable inside the c - arm may break. a cable break will result in restricted functionality or system failure.
  • Action
    A Siemens service technician will contact affected customers to organise the modification of the cable routing to prevent the issue from occurring. This action has been closed-out on 14/07/2016.

Device

Artis zeego systems with a C - arm (Fluoroscopic X-ray systems)
  • Model / Serial
    Artis zeego systems with a C - arm (Fluoroscopic X-ray systems)C - arm serial number range: 1000 to 1599ARTG number: 102177
  • Manufacturer
    Siemens Ltd

Manufacturer

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