Syngo.Via Software (2013-09-19)

Starting date:

September 19, 2013

Posting date:

October 31, 2013

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-36477

• Reason
• Affected products

Recalled Products

Syngo.Via Software

Reason

Siemens is providing an update package for all systems running on Syngo.Via software version VA20. This resolves issues encountered with the following software applications:

Syngo.Via CT

In workflows that contain the MM reading workflow step, especially,CT Neuro Perfusion and CT Dynamic Angio, data may not have been loaded to the MM reading workflow step if the data set was assigned to such a workflow scanner site.

In CT Bone reading, the Edit Rib function did not work properly:  After scrolling multiple times in an MPR image, the marker disappeared, and after editing a centerline multiple times, the edited rib was not correctly displayed in the unfolded rib view.

In CT Coronary Analysis, heart segmentation in VRT images may have been of poor quality as some parts of the heart were missing.

In CT Cardiac Function, the identification of the annular plane did not work in pediatric studies although the system confirmed a completion of preprocessing, preprocessing was not completed.

Syngo.Via MR

In the Neuro Perfusion workflow the task "remaining images" was missing. Therefore it could happen that some series were not available in the workflow.

Syngo.Via MI

In MM Oncology, editing a contour could lead to an erroneous segmentation.

Affected products