| 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 |
|
| 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 |