Events

Recall of ARTIS Q, ARTIS pheno systems and X-ray generator

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-00836-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2018-06-26
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00836-1
  • 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 have identified that in the event of a short-circuit within the x-ray tube, a current leakage may cause an overload of the x-ray generator. if this current leak remains undetected it may cause damage to the generator by overheating after-which, taking an x-ray will not be possible.
  • Action
    Siemens are advising they will contact customers to schedule the installation of a Residual Current Device (RCD) on affected generators in order to detect current leakages.

Device

ARTIS Q, ARTIS pheno systems and X-ray generator
  • Model / Serial
    ARTIS Q, ARTIS pheno systems and X-ray generatorCatalogue number: 10848282, 10848281, 10848280, 10848283, 10848355, 10849000ARTG Number: 273952(Siemens Healthcare Pty Ltd - 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