Events

Recall of Ysio Max, Luminos dRF Max and Luminos Agile Max (with software version VE10 including SmarthOrtho license)

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-01318-1
  • Event Risk Class
    Class II
  • Event Initiated Date
    2014-12-15
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01318-1
  • 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 identified a potential malfunction which can occur when composed images are flipped on the integrated imaging system flourospot compact. when composed images are flipped (vertically or horizontally) the image information might become corrupted as a result of a software malfunction. the affected images and associated annotations such as labels (e.G. r/l) may show incorrectly.The corrupt image information might lead to an incorrect diagnosis.
  • Action
    Siemens is providing a new software version that will permanently resolve the described malfunction. In the interim end users are advised to follow work around instructions to ensure the safe use of the systems Ysio Max, Luminos dRF Max and Luminos Agile Max systems. This action has been closed-out on 08/08/2016.

Device

Ysio Max, Luminos dRF Max and Luminos Agile Max (with software version VE10 including SmarthOrtho...
  • Model / Serial
    Ysio Max, Luminos dRF Max and Luminos Agile Max (with software version VE10 including SmarthOrtho license) ARTG Number: 102182, 102184
  • Manufacturer
    Siemens Ltd

Manufacturer

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