Events

Recall of Artis Zeego Systems (Fluoroscopic diagnostic x-ray system for angiographic procedures) with SW revision VC14, VC20 & VC21 in conjunction with a specific technical configuration

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-2012-RN-01165-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2012-11-30
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-01165-1
  • 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
    In the course of siemens' product monitoring activities, a potential risk for patient or operators was determined during the operation of an artis zeego system with sw revision vc14, vc20 & vc21 in conjunction with a specific technical configuration which cannot be completely excluded. in case of an unlikely failure of brake, the c-arm may descent.This recall action was undertaken by siemens ltd before it was agreed with the tga.
  • Action
    All the affected systems were checked by Siemens technical engineer for the potential for the failure mode to occur.

Device

Artis Zeego Systems (Fluoroscopic diagnostic x-ray system for angiographic procedures) with SW re...
  • Model / Serial
    Artis Zeego Systems (Fluoroscopic diagnostic x-ray system for angiographic procedures) with SW revision VC14, VC20 & VC21 in conjunction with a specific technical configuration ARTG Number: 102177
  • Manufacturer
    Siemens Ltd

Manufacturer

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