Reported Jun 10, 2020 · Terminated
ARTIS icono systems with Quantification Application SW (QVA/QCA) on a standalone XWP computer, an interventional…
Siemens Medical Solutions USA, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Siemens Medical Solutions USA, Inc · 40 Liberty Blvd · Malvern, PA · 19355
Is this the product you have?
- ARTIS icono systems with Quantification Application SW (QVA/QCA) on a standalone XWP computer, an interventional
- Fluoroscopic X-Ray System Model Number11327600
- Lot codes and dates
- Serial Numbers180014 180015 180018 180019 180029
- Amount recalled
- 5 US
Where it was sold
Why it was 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
This product could cause temporary or reversible health problems — stop using it.
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