[Recalled] ARTIS icono systems with Quantification Application SW (QVA/QCA) on a standalone XWP computer, an interventional Fluoroscopic X-Ray System Model Number: 11327600 — Using Quantification Application (QVA/QCA) on DSA images may lea

The product on this page is subject to an official recall. We summarise the regulator's findings and the recommended action.

Recall details

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: 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

This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

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This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.