Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall 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

U.S. FDA — Device Enforcement · United States · 2020-04-23 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2257-2020
Date of alert
2020-04-23
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Siemens Medical Solutions USA, Inc
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
11327600
Reported risk: 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
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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