Events

Recall of Artis systems with large display module

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-01109-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-11-23
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01109-1
  • 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
    Due to improper soldering in limited components of a specific production lot of large display bypass module, a loss of video signal could potentially occur (will not show any image). radiation can still be applied without image, which could result in dose to the patient without clinical benefit. the error has not been observed in the field.
  • Action
    Siemens will be replacing any potentially affected units with unaffected stock. This action has been closed-out on 24/08/2016.

Device

Artis systems with large display module
  • Model / Serial
    Artis systems with large display moduleSiemens Material Numbers: 10094135, 10094137, 10094141, 10094142, 10280959, 10848280, 10848281, 10848282, 10848283, 10848354 and 10848355ARTG Number: 102177
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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