Events

Recall of Siemens Ysio Max, Luminos dRF Max, Luminos Agile Max and Uroskop Omnia Max with software version VE10E(fluoroscopic and standard 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-2015-RN-00361-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2015-04-23
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00361-1
  • 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
    Images might be lost and corresponding acquisitions have to be repeated under the following circumstances:· during an image recovery process on systems with portable detectors (max wi-d, max mini) the connection of the portable detector is sporadically not re-established.· if either the “undo” button on the rad subtask card or the “previous series” button on the image subtask card are pressed during image readout.· sporadically, during an automatic or a manual ris update. this may cause the deletion of the currently used study and all acquired images within this study.
  • Action
    Siemens is providing temporary instructions for users to follow to prevent the issues from occurring. A software update will be available in Q2 2015 which will permanently resolve the issue. This action has been closed-out on12/08/2016.

Device

Siemens Ysio Max, Luminos dRF Max, Luminos Agile Max and Uroskop Omnia Max with software version ...
  • Model / Serial
    Siemens Ysio Max, Luminos dRF Max, Luminos Agile Max and Uroskop Omnia Max with software version VE10E(fluoroscopic and standard diagnostic x-ray systems )Catalogue Numbers: 10762470, 10762471ARTG Numbers: 102184, 102182, 213886
  • Manufacturer
    Siemens Ltd

Manufacturer

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