syngo.via RT Image Suite with software versions recall: Software Issue
syngo.via RT Image Suite with software versions syngo.via VB30 or VB40
Why was syngo.via RT Image Suite with software versions recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
syngo.via VB30 or VB40: All Lots Model #: 10496180
- Product
- syngo.via RT Image Suite with software versions syngo.via VB30 or VB40
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Quantity
- 21 units
- Distribution
- 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.
- Recall date
- July 29, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)