CLASS II Device recall · Reported 10 Jun 2020 · FDA Enforcement Report

Artis icono systems with Quantification Application SW recalled

Siemens Medical Solutions USA is recalling Artis icono systems with Quantification Application SW (QVA/QCA) on a standalone XWP, distributed in Arizona, Illinois, Utah, Wisconsin. The recall was initiated on 23 Apr 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial Numbers: 180014 180015 180018 180019 180029

Quantity recalled5 US

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2257-2020
FDA event ID: 85615
Recalling firm: Siemens Medical Solutions USA, Malvern, PA
Classification: Class II
Status: Terminated
Recall initiated: 23 Apr 2020
FDA classified: 3 Jun 2020
Reported: 10 Jun 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Lead & Heavy Metals
Device type: Imaging Equipment

Timeline

23 Apr 2020	Recall initiated by company
3 Jun 2020	Classified by FDA	+41 days
10 Jun 2020	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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

Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.

Product as listed by the FDA

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

Where it was distributed

AZ, IL, UT, WI

Arizona Illinois Utah Wisconsin

Questions about this recall

Is Artis icono systems with Quantification Application SW (QVA/QCA) on a standalone XWP recalled?

Yes. Siemens Medical Solutions USA recalled Artis icono systems with Quantification Application SW (QVA/QCA) on a standalone XWP on 23 Apr 2020. The recall is Class II and its status is Terminated. Recall number Z-2257-2020.

Why was it recalled?

Which lots are affected?

Serial Numbers: 180014 180015 180018 180019 180029

Where was it sold?

AZ, IL, UT, WI

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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