RecallWatchUSA

Home / Recalls / Medical Devices

Siemens Medical Solutions USA, Inc recalls syngo.via RT Image Suite with software versions syngo.via VB30 or VB40

Recalled July 29, 2020 · FDA recall Z-2688-2020 · Siemens Medical Solutions USA

Hazard
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 occurence of this issue is very unlikely and has never been reported so far. · FDA Class II
Units
21 units
Sold at
US Nationwide distribution including in the states of AZ, MA, WI, FL, PA. TX, MD, LA, TX, MN, MI, NY, SC, OH, GA, CA, IL, MO, CA, TX.

Description

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 occurence of this issue is very unlikely and has never been reported so far.

Product
syngo.via RT Image Suite with software versions syngo.via VB30 or VB40
Manufacturer(s)
Siemens Medical Solutions USA, Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →

Siemens Medical Solutions USA, Inc recalls syngo.via RT Image Suite with software versions syngo.via VB30 or VB40 | RecallWatchUSA