Events

Recall of Luminos dRF (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-00456-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-04-17
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00456-1
  • 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
    Under rare environmental conditions (i.E., extremely dry air in combination with a highly isolated floor) electrostatic discharges (esd) >8 kv at the system control console may trigger an unintended movement of the system which may cause an emergency situation, danger to the patient (e.G., falling off the table, squeezing), to operating personnel or to the unit. to date, a sporadic occurrence of this system malfunction has been reported from two sites.
  • Action
    Customers are advised to press one of the red emergency STOP buttons immediately in case of an unintended movement. The system needs to be restarted afterwards to be fully functional again. Siemens is preparing a modification of the Luminos dRF system control console that will resolve this potential malfunction. The field modification will be available from May 2014.

Device

Luminos dRF (Fluoroscopic diagnostic x-ray systems)
  • Model / Serial
    Luminos dRF (Fluoroscopic diagnostic x-ray systems)Catalogue number: 10094200 ARTG Number: 102182
  • Product Classification
    Radiology Devices
  • Manufacturer
    Siemens Ltd

Manufacturer

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