Events

Recall of Wireless Foot Switch - Artis systems

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-00325-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2017-03-08
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00325-1
  • 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 whereby the gap in the housing of the wireless foot switch can result in liquids penetrating the interior. liquids may include disinfection and cleaning agents as well as bodily fluids. this can result in the failure of the foot switch. if the foot switch fails, it will no longer be possible to use it to release radiation. the hand switch provided can still be used to release exposures, but fluoroscopic examinations will not be possible. consequently, a situation may arise whereby it is necessary to cancel or restart clinical treatment or to transfer treatment to a functioning system.
  • Action
    Siemens is currently working on a solution which is expected during the second quarter of 2017. Siemens generally recommend the use of sterile covers to protect the foot switch from all types of contamination. This is an effective way to prevent the foot switch from coming into contact with liquids. In the event of foot switch failure, users are further advised that the release of radiation for imaging purposes is still possible using the hand switch. Users are to note that standard emergency processes should be in place and ready for implementation until corrective actions are carried out.

Device

Wireless Foot Switch - Artis systems
  • Model / Serial
    Wireless Foot Switch - Artis systemsCatalogue Numbers: 4787797, 4787805, 4787813(Artis Systems supplied after 01 January 2005)ARTG Number: 145549
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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