Events

Recall of Ysio Max, Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max with software version VE10A to VE10C

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-00992-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-09-15
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00992-1
  • 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
    Loss of images - if an automatic ris worklist update is performed while a patient is already selected for examination, the subsequently acquired images of this patient might get lost under certain circumstances and cannot be recovered. this malfunction is not detectable to the user during the examination. only after the patient study is opened in the “examined patients” list, the user will be able to recognize that the acquired images are not available and irreversibly lost.Incorrect labels and annotations - under certain circumstances the image label (l, r) and annotations are displayed incorrectly after images have been sent to pacs or hardcopy/filming.
  • Action
    Siemens are working on a software update to correct both malfunctions. In the interim Siemens is providing the following work around instructions: - To avoid the potential risk of lost images Siemens is advising their customers to disable the automatic RIS worklist update and perform this procedure manually. - To ensure the correct orientation of images Siemens recommends to always use lead letters to indicate patient orientation on the x-ray image. This action has been closed-out on 06/06/2016.

Device

Ysio Max, Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max with software version VE10A to VE10C
  • Model / Serial
    Ysio Max, Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max with software version VE10A to VE10CARTG numbers – 102184, 102182
  • Manufacturer
    Siemens Ltd

Manufacturer

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