Events

Recall of Artis Systems 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-2017-RN-00813-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2017-06-23
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00813-1
  • 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 identified an issue where large amounts of liquid can enter the artis table which may result in electric table movement failure. the patient table will not be able to be moved, or will only have limited movements. if function failure occurs, it could result in a situation where it may be necessary to cancel treatment or restart clinical treatment on a functioning system.
  • Action
    Various gaps and openings on the top of the table will recieve additional sealing.

Device

Artis Systems in conjunction with Artis Table
  • Model / Serial
    Artis Systems in conjunction with Artis TableCatalogue Numbers: 5904441, 7728392, 7412807, 7413078, 7008605, 7555357, 7555373, 7727717, 10094141, 10094135, 10094137, 10280959, 10848281, 10848280, 10848283, 10848282 with Artis tableARTG Numbers: 273952, 222194 and 274081
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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