Events

Recall of Artis systems with Artis tables

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-2017-RN-01506-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-12-14
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01506-1
  • 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 systems with artis tables. the artis table top carriage is mounted on top of the table base and fixed with a bolt. a snap right is used to secure the bolt. in the case of a missing or wrongly installed snap ring the bolt could slide out of its base, and the table top carriage will slide to the floor.
  • Action
    Siemens Healthcare will be in contact with affected customers to arrange for a service to ensure the snap ring has been installed correctly.

Device

Artis systems with Artis tables
  • Model / Serial
    Artis systems with Artis tablesCatalogue number – Artis systems – 5904433, 7008605, 7412807, 7413078, 7555357, 7555365, 7727717, 7728392, 10094135, 10094137, 10094139, 10094141, 10280959, 10848280, 10848281, 10848282, 10848283, 10848353, 10848355, 10848600, 10849000 in combination with various different material number tables.ARTG: 273952
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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