Company: Siemens Medical Solutions USA, Inc
Date of Enforcement Report: 7/29/2020
Class II

PRODUCT

Syngo.via RT Image Suite with software versions syngo.via VB30 or VB40

Recall Number: Z-2688-2020

REASON

If the user modifies for any reason (e.g. reduction of artifacts) the original image orientation of a standard MR protocol to acquire images in a different orientation for further processing in Synthetic CT , the software does not recognize the adapted acquisition plane. This may result in images with wrong geometry. When this distortion remains unnoticed and the images are subsequently exported to a treatment planning system (TPS), an incorrect calculated radiation treatment plan cannot be excluded. The occurrence of this issue is very unlikely and has never been reported so far.

RECALLING FIRM/MANUFACTURER

Siemens Medical Solutions USA, Inc on 6/24/2020. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

21 units

DISTRIBUTION

U.S. Nationwide