Events

Recall of Luminos dRF and Luminos dRF Max systems(Fluoroscopic diagnostic x-ray systems)

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Siemens 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-2014-RN-00923-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-08-21
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00923-1
  • 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
    There is the potential for malfunction when exposing the table side control panel of the luminos drf / luminos drf max system to fluids. if the panel is infiltrated by fluids, malfunctions may occur when buttons on the control panel are pressed, in the worst case the patient may slip off the table if the table is activated erroneously. in a very unlikely scenario, fluid may cause a permanent short circuit within the control panel and automatically disable the affected button(s) with the start-up of the system. in this case the system remains functional as it can be operated via the remote control panel.
  • Action
    Siemens is advising end users to avoid extensive exposure of fluids to the table side control panel when using the system. When cleaning the system, please make sure that you do not apply excessive fluids: i.e., only use damp towels, in accordance with the product manual. The remote control panel is not affected by any malfunction of the table side control panel and can reliably be used at any time. Siemens is currently working on a permanent solution to eliminate the risk of fluid infiltration. This action has been closed-out on 24/05/206.

Device

Luminos dRF and Luminos dRF Max systems(Fluoroscopic diagnostic x-ray systems)
  • Model / Serial
    Luminos dRF and Luminos dRF Max systems(Fluoroscopic diagnostic x-ray systems)Luminos dRF systems with software version VD10Catalogue Number: 10094200Luminos dRF Max systems with software version VE10Catalogue Number: 10762471ARTG Number: 102182
  • Manufacturer
    Siemens Ltd

Manufacturer

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