Events

Recall of ARTIS Zeego (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-00383-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-04-01
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00383-1
  • 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 healthcare has determined that the crimping of motor connectors a1 to a3 may have been incorrectly carried out. incorrectly executed crimping where the crimping tool was used on the wrong point of the crimp contact has led to substandard contacting. the resulting increase in interference resistance can cause heat build up and potentially lead to scorching of the corresponding cables.
  • Action
    Siemens will be inspecting the connectors to ensure they are correctly crimped at the A1 to A3 motor terminals. A Siemens representative will be in touch to schedule the visit.

Device

ARTIS Zeego (Fluoroscopic angiographic x-ray system)
  • Model / Serial
    ARTIS Zeego (Fluoroscopic angiographic x-ray system)Serial number of the motor connectors lower than 946925
  • Manufacturer
    Siemens Ltd

Manufacturer

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