Siemens syngo.via RT Image Suite Software Recall for Geometry Errors
Siemens is recalling syngo.via RT Image Suite software versions VB30 and VB40 because modified MR image orientations may result in incorrect geometry and radiation treatment plans.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (radiation treatment planning) where injury has not yet been reported, and the source explicitly states the issue has never been reported, fitting the 'High' severity criteria for theoretical hazards without confirmed illness.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling 21 units of the syngo.via RT Image Suite software, specifically versions VB30 and VB40. The recall was initiated because the software may fail to recognize adapted acquisition planes when users modify the original image orientation of standard MR protocols for Synthetic CT processing. This defect can result in images with incorrect geometry.
If these distorted images are exported to a treatment planning system, there is a risk of an incorrectly calculated radiation treatment plan. The source text notes that the occurrence of this issue is very unlikely and has never been reported so far. The affected units were distributed nationwide in the United States, including in the states of AZ, MA, WI, FL, PA, TX, MD, LA, MN, MI, NY, SC, OH, GA, CA, and IL.
Healthcare facilities using this software should contact Siemens Medical Solutions USA, Inc. for instructions on how to address the software defect. The recall is classified as Class II by the FDA.
The recalled product
- Product
- syngo.via RT Image Suite with software versions syngo.via VB30 or VB40
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Category
- Medical Device — Software
- Affected units
- 21
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- syngo.via VB30 or VB40: All Lots Model #: 10496180
Distribution
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