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FDAApril 23, 2020device

ARTIS icono systems with Quantification Application SW (QVA/QCA) on a standalone XWP computer, an interventional Fluoroscopic X-Ray System Model Number: 11327600

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Terminated

Brands named

siemens medical solutionssiemenssiemens medical

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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