Siemens Medical Solutions USA, Inc recalls ARTIS icono systems with Quantification Application SW (QVA/
Recalled Product
ARTIS icono systems with Quantification Application SW (QVA/QCA) on a standalone XWP computer, an interventional Fluoroscopic X-Ray System Model Number: 11327600
Hazard / Issue
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
Issued by
FDA
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