Events

Recall of Ysio Systems with fixed detector in the wall stand, software version VC10 (Diagnostic digital x-ray system)

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-00956-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-09-05
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00956-1
  • 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 received several reports from customers that in case of ysio with fixed detector in the wall stand, an unlikely error may occur, resulting in line artifacts in the image. should these artifacts appear in the region of interest, the examination may need to be repeated.
  • Action
    Siemens service engineer will contact affected customers to organise and implement a hardware upgrade which will resolve the issue. This action has been closed-out on 06/06/2016.

Device

Ysio Systems with fixed detector in the wall stand, software version VC10 (Diagnostic digital x-r...
  • Model / Serial
    Ysio Systems with fixed detector in the wall stand, software version VC10 (Diagnostic digital x-ray system)Catalogue Numbers: 10281013, 10281163 ARTG number: 102184
  • Manufacturer
    Siemens Ltd

Manufacturer

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