ARTIS icono systems with Quantification Application SW (QVA/QCA) on a standalone XWP computer, an interventional Fluoroscopic X-Ray System Model Number: 11327600
Reported: June 10, 2020 Initiated: April 23, 2020 #Z-2257-2020
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
Details
- Recalling Firm
- Siemens Medical Solutions USA, Inc
- Units Affected
- 5 US
- Distribution
- AZ, IL, UT, WI
- Location
- Malvern, PA
Frequently Asked Questions
What product was recalled? ▼
ARTIS icono systems with Quantification Application SW (QVA/QCA) on a standalone XWP computer, an interventional Fluoroscopic X-Ray System Model Number: 11327600. Recalled by Siemens Medical Solutions USA, Inc. Units affected: 5 US.
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 10, 2020. Severity: Moderate. Recall number: Z-2257-2020.
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