Home / Recalls / Medical Devices
Siemens Medical Solutions USA, Inc recalls ARTIS icono systems with Quantification Application SW (QVA/QCA) on a standalone XWP computer, an interventional Fluoros
Recalled June 10, 2020 · FDA recall Z-2257-2020 · Siemens Medical Solutions USA
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 · FDA Class II
Units
5 US
Sold at
AZ, IL, UT, WI
Description
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
Product
ARTIS icono systems with Quantification Application SW (QVA/QCA) on a standalone XWP computer, an interventional Fluoroscopic X-Ray System Model Number: 11327600
Manufacturer(s)
Siemens Medical Solutions USA, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →