medical Class II Updated 2020-06-10

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

Affected States: AZ, IL, UT, WI
Lot/Code Info: Serial Numbers: 180014 180015 180018 180019 180029
View official government recall

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