Z-2257-2020 Class II Terminated
FDA device recall Z-2257-2020 was initiated by Siemens Medical Solutions USA, Inc on April 23, 2020 and is designated Class II. 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 inappropriat… The recall status is terminated (terminated October 26, 2020). Affected quantity: 5 US.
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