Events

Recall of Artis One in conjunction with 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-2018-RN-00054-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-01-19
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00054-1
  • 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 has been made aware of an issue with the artis one systems in conjunction with artis tables. the artis table top carriage is mounted on top of the table base and fixed with a bolt. a fixation ring is used to secure the bolt. in the event of a missing or wrongly installed fixation ring, the bolt will remain in place and the patient table may appear to operate normally. in extreme cases after long periods of use, the bolt persistently bears the unexpected force from non-vertical direction and may slide out of its base and lead to the table top carriage slide to the floor. no complaints have been received for the artis one system to date.
  • Action
    Siemens will be in contact with affected users to arrange for a service technician to examine potentially affected tables. The positioning of the bolt as well as the fixation rings will be verified and if necessary corrected or replaced.

Device

Artis One in conjunction with table
  • Model / Serial
    Artis One in conjunction with tableCatalogue number – 10848600ARTG number – 222194 (Siemens Healthcare Pty Ltd- Artis one - X-ray system, diagnostic, fluoroscopic, angiographic, stationary, digital)
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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