FDAFDA · Food and drugs·Recall number Z-2257-2020
ARTIS icono systems with Quantification Application SW (QVA/QCA) on a standalone XWP computer, an interventional Fluoroscopic X-Ray System Model Number: 11327600
Published June 10, 2020 · Recall initiated: April 23, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's 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
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Distributor
- AZ, IL, UT, WI
- Lot
- Serial Numbers: 180014 180015 180018 180019 180029
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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