Device product
ARTIS icono systems with Quantification Application SW (QVA/QCA) on a standalone XWP computer, an interventional Fluoroscopic X-Ray System Model Number: 11327600
Z-2257-2020
Product summary
- Event
- Event 85615
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5 US
- Official record key
device-enforcement:Z-2257-2020
Official wording
Reason: 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
Code information: Serial Numbers: 180014 180015 180018 180019 180029
Distribution pattern: AZ, IL, UT, WI
Derived failure modes
-
Unknown
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