Z-2257-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- June 10, 2020
- Initiation Date
- April 23, 2020
- Termination Date
- October 26, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5 US
Product Description
ARTIS icono systems with Quantification Application SW (QVA/QCA) on a standalone XWP computer, an interventional Fluoroscopic X-Ray System Model Number: 11327600
Reason for Recall
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
Distribution Pattern
AZ, IL, UT, WI
Code Information
Serial Numbers: 180014 180015 180018 180019 180029