Print version of this report
Type of Product Medical Device
TGA Recall Reference RC-2015-RN-01151-1
Product Name/Description syngo X-Workplace with software VD10E and tabcard ”4D”

Siemens Material Numbers: 105025522 and 10281299

ARTG Number: 160941
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 1/12/2015
Responsible Entity Siemens Healthcare Pty Ltd
Reason/Issue 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.
Recall Action Recall for Product Correction
Recall Action Instructions 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.
Contact Information 1800 310 300 - Siemens Technical Support Centre