| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2022-RN-01330-1 |
| Product Name/Description |
Syngo.via with VB20, VB30, VB40, VB60 and VB70 software
ARTG 371150
(Siemens Healthcare Pty Ltd - Radiology DICOM image processing application software) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
14/11/2022 |
| Responsible Entity |
|
| Reason/Issue |
Siemens has become aware that under certain circumstances, distance measurement values in MRI images might be wrong in syngo.via.
In case:
1. Enhanced MRI images with rectangular FoV (Field of View) are created at the MR scanner and sent to syngo.via, and
2. at the syngo.via system, the user rotates the images to display the images in arbitrary orientation and saves them, and
3. afterwards, the user exports the images to another DICOM node using MR Export Rules (interoperability mode)
then distance measurements on the newly created series might be wrong when being performed at systems that receive these new series. |
| Recall Action |
Product Defect Correction |
| Recall Action Instructions |
Customers are advised to follow the workaround steps outlined in the customer letter (supplied to impacted facilities). Siemens will solve the issue with a software update which is now available.
This action has been closed out on 29/01/2024 |
| Contact Information |
1800 310 300 - Siemens Customer Care Centre |