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