Safety Alerts

The Australian Therapeutic Goods Administration (TGA) has posted a medical device safety alert concerning Siemens Healthcare Syngo.via with VB20, VB30, VB40, VB60 and VB70 software [HKMD No.: 120476].

According to the TGA, the manufacturer 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.

For further information, please visit https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2022-RN-01330-1

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 16 Nov 2022