Events

Recall of Artis systems used in conjunction with Artis table

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Siemens Healthcare Pty 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-2015-RN-00677-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-07-28
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00677-1
  • 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
    For artis systems used in conjunction with artis table;- in the event the tabletop is approximately fully extended at the head end and there is a large amount of liquid on the table surface, the liquid may make its way from the foot end of the tabletop onto the top cover of the table column where it can seep through a gap. this liquid may then cause interference with electronic components and table movements may no longer be possible.
  • Action
    The gap in the top of the table cover will be sealed to ensure protection against the entry of liquids.

Device

Artis systems used in conjunction with Artis table
  • Model / Serial
    Artis systems used in conjunction with Artis tableCatalogue and Serial number – Multiple serial number ranges of Artis tables with the following Siemens Material Numbers: 5767004 5767012 5767020 5767053 10759275 10759276 10759277 10759278ARTG number – 102173 and 102177
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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