Siemens Medical Solutions Recalls syngo.via Cardiac Planning Software
Siemens Medical Solutions is recalling syngo.via syngo.CT Cardiac Planning software due to a potential risk of incorrect measurements during TAVI planning procedures.
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 (medical device software) where injury has not yet been reported, which aligns with the 'High' severity criteria in the rubric.
Plain-English summary
Siemens Medical Solutions USA, Inc. is recalling syngo.via syngo.CT Cardiac Planning software, Model Number 10496180. The affected software versions are VB20A and VB30A. A total of 112 units were distributed nationwide in the United States, including in states such as AK, AL, AR, AZ, CA, CT, FL, GA, IA, IL, KS, KY, MA, MD, MI, MN, MO, MS, MT, NC, NH, NJ, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, and WI.
The recall is due to a software issue in the TAVI algorithm that creates a potential risk of a wrong measurement in the annulus plane during a TAVI planning procedure. The software is designed to support physicians in evaluating cardiac CT angiography volume sets and determining functional parameters of the left and right ventricles.
Healthcare facilities and users of the affected software should contact Siemens Medical Solutions USA, Inc. for further instructions on how to address the software issue.
The recalled product
- Product
- syngo.via syngo.CT Cardiac Planning, Model Number 10496180 Product Usage: Syngo.CT Cardiac Planning and syngo CT. Cardiac Function are image analysis software packages for evaluating cardiac CT angiography (CTA) volume sets. The software packages are designed to support the p
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Category
- Medical Device — Software
- Hazard
- Affected units
- 112
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)
- Software versions VB20A or VB30A
Distribution
Part of a larger recall action
This product is one of 2 recalled by Siemens Medical Solutions USA, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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