Events

Recall of Luminos dRF and Uroskop Omnia systems with Software Version VD10

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-2013-RN-01083-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2013-10-25
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01083-1
  • 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 the following potential malfunctions:1. during a rad (radiography) examination with automatic exposure control, a highly unlikely malfunction can result in radiation continuing longer than required. this malfunction happens when the generator stops the tube power too late and therefore too much dose is applied during an acquisition. this may also result in an overexposed image that is not of diagnostic quality, so that the examination needs to be repeated. (note: this issue also affects software versions vc10 and vb10. devices running this software are being corrected under recall rc-2013-rn-01037-1.)2. when selecting a tomo ogp, in some cases the luminos drf system shows a message "wait for flc" and this state does not change on its own.3. radiation is not activated and therefore an exposure is performed without radiation.
  • Action
    It is not possible for the user to prevent this malfunction. The exposure time with the use of automatic exposure control is limited to 500ms, which is the maximum time that unwanted radiation will continue. The exposure can be interrupted by the user at anytime by releasing the exposure button. Siemens has implemented a field modification that will resolve the issues. The Australian roll out of this field modification is planned for completion in Q4 2013/Q1 2014.

Device

Luminos dRF and Uroskop Omnia systems with Software Version VD10
  • Model / Serial
    Luminos dRF and Uroskop Omnia systems with Software Version VD10Catalogue Numbers:10094200, 10094910Siemens Reference Numbers: XP031/13/SARTG Number: 102184
  • Manufacturer
    Siemens Ltd

Manufacturer

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