Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
ARTIS icono systems with Quantification Application SW (QVA/QCA) on a Recalled by Siemens Medical Solutions USA, Inc Due to Using Quantification Application (QVA/QCA) on DSA images may...
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
ARTIS icono systems with Quantification Application SW (QVA/QCA) on a standalone XWP computer, an interventional Fluoroscopic X-Ray System Model Number: 11327600
Quantity: 5 US
Why Was This Recalled?
Using Quantification Application (QVA/QCA) on DSA images may lead to a failure in vessel detection or incorrect quantification of vessel detection and result in an incorrect diagnosis and inappropriate treatment of the patient
Where Was This Sold?
This product was distributed to 4 states: AZ, IL, UT, WI
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