Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
syngo.via syngo.CT Cardiac Function Recalled by Siemens Medical Solutions USA, Inc Due to There is a potential risk of a wrong...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Siemens Medical Solutions USA, Inc directly.
Affected Products
syngo.via syngo.CT Cardiac Function, 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 physician in determining the functional parameters of the left and right ventricles, confirming the presence or absence of physicianidentified myocardial enhancement defects and evaluation documentation and follow-up of any such finding.
Quantity: 112 total
Why Was This Recalled?
There is a potential risk of a wrong measurement in the annulus plane during a TAVI planning procedure. This risk is due to a software issue found in the TAVI algorithm.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Siemens Medical Solutions USA, Inc
Siemens Medical Solutions USA, Inc has 613 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report