Events

Recall of Ysio Systems (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-00558-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-05-16
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00558-1
  • 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
    If excessive liquid is used for cleaning, the liquid may infiltrate the generator console and cause a short circuit which may lead to an unintended release of radiation. to date, only one customer has reported this occurrence.
  • Action
    Siemens has prepared a modification to resolve the potential issue by sealing the generator consoles of the Ysio Systems against infiltration of liquid. This modification will be installed as field correction likely to occur during 2nd to 4th quarter 2014. Until the modification is implemented, users are advised to strictly follow the user manual to avoid liquid infiltration into the generator console. This action has been closed-out on 18/08/2016.

Device

Ysio Systems (X-ray system)
  • Model / Serial
    Ysio Systems (X-ray system)Catalogue Numbers: 10281013 & 10281163ARTG Number: 102184
  • Manufacturer
    Siemens Ltd

Manufacturer

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