syngo X-Workplace with software VD10E and tabcard ”4D”Siemens 의 리콜

Recall

RC-2015-RN-01151-1

Class II

2015-12-01

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01151-1

There is a software related issue with the syngo x-workplace (s/w vd10e) and tabcard "4d" viewer application. when a volume is acquired with a ct scanner with a tilted gantry, the measurements displayed in the 4d tabcard can be incorrect, due to incorrect calculations in the multi-planar reformattings (mprs) of the volume. this might potentially result in the physician selecting a device with the wrong size (too small), which then needs to be exchanged. in the event that the device needs to be exchanged, it could lead to a medium term delay in a clinical procedure.

The sponsor Siemens will contact the affected customers to arrange for the installation of a software update which will eliminate the reported problem. Users are advised to load the MPR acquired at a CT scanner with tilted gantry into “viewing” application and perform 2d measurements there until the software update has been installed. This action has been closed-out on 29/08/2016.