Recall – DSA image application may lead to incorrect diagnosis

Company: Siemens Medical Solutions USA, Inc
Date of Enforcement Report: 6/10/2020
Class II

PRODUCT

ARTIS icono systems with Quantification Application SW (QVA/QCA) on a standalone XWP computer, an interventional Fluoroscopic X-Ray System Model Number: 11327600

Recall Number: Z-2257-2020

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

RECALLING FIRM/MANUFACTURER

Siemens Medical Solutions USA, Inc on 4/23/2020. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

5 US

DISTRIBUTION

US Nationwide

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IEC 62304 and Emerging Standards and FDA Expectations for Medical Device and Health IT Software – Virtual

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