Events

Recall of syngo X-Workplace with software VD10E and tabcard ”4D”Siemens

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-2015-RN-01151-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-12-01
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01151-1
  • 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 a software related issue with the syngo x-workplace (s/w vd10e) and tabcard "4d" viewer application. when a volume is acquired with a ct scanner with a tilted gantry, the measurements displayed in the 4d tabcard can be incorrect, due to incorrect calculations in the multi-planar reformattings (mprs) of the volume. this might potentially result in the physician selecting a device with the wrong size (too small), which then needs to be exchanged. in the event that the device needs to be exchanged, it could lead to a medium term delay in a clinical procedure.
  • Action
    The sponsor Siemens will contact the affected customers to arrange for the installation of a software update which will eliminate the reported problem. Users are advised to load the MPR acquired at a CT scanner with tilted gantry into “viewing” application and perform 2d measurements there until the software update has been installed. This action has been closed-out on 29/08/2016.

Device

syngo X-Workplace with software VD10E and tabcard ”4D”Siemens
  • Model / Serial
    syngo X-Workplace with software VD10E and tabcard ”4D”Siemens Material Numbers: 105025522 and 10281299ARTG Number: 160941
  • Manufacturer
    Siemens Healthcare Pty Ltd

Manufacturer

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