Events

Safety Alert for Syngo X-Workplace with software version VD10E

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Siemens..

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2016-03-16
  • Event Date Posted
    2016-03-16
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20160316.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: siemens syngo x-workplace with software version vd10e the therapeutic goods administration (tga) of australia has posted a medical device safety alert concerning syngo x-workplace with software version vd10e, manufactured by siemens. [catalogue numbers: 10094165, 10281299 and 10502522 when used in combination with carto systems]. according to the manufacturer, an issue can occur after the export of segmentation results of the left atrium created on syngo x workplace to an electro-anatomical 3d mapping carto system. after importing, the segmentation result appears mirrored at the carto system, and cannot be used for the ablation procedure. although unlikely, there is a risk of serious health effects if the incorrect image is used for ablation. the manufacturer is advising users that a software upgrade will be performed as a permanent correction. users are advised to stop using any segmentation result for export to the carto system until the software upgrade is performed. for details, please refer to the tga website: http://apps.Tga.Gov.Au/prod/sara/arn-detail.Aspx?k=rc-2016-rn-00267-1 if you are in possession of the affected products, please contact your supplier for necessary actions posted on 16 march 2016.

Device

Syngo X-Workplace with software version VD10E
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Siemens Syngo X-Workplace with software version VD10E
  • Manufacturer
    Siemens.

Manufacturer

Siemens.