Events

Recall of AXIOM Artis 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-00136-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-02-07
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00136-1
  • 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
    Axiom artis systems with certain serial numbers are using flat detector cooling unit with inappropriate connectors that may leak. this might cause a system failure resulting in a drop out of the gantry system.
  • Action
    All connectors will be checked for leak tightness and an additional protection unit will be installed by Siemens' technicians. This will prevent leakages in the connector and therefore, the potential drop out of the gantry system can be avoided.

Device

AXIOM Artis Systems (fluoroscopic angiographic x-ray system)
  • Model / Serial
    AXIOM Artis Systems (fluoroscopic angiographic x-ray system)Catalogue Numbers: 7412807, 7728392Serial Numbers: 35031, 44018ARTG Number: 102173
  • Product Classification
    Radiology Devices
  • Manufacturer
    Siemens Ltd

Manufacturer

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