CLASS II Device recall · Reported 5 May 2021 · FDA Enforcement Report

Interventional Fluoroscopic X-Ray System Artis icono recalled

Siemens Medical Solutions USA is recalling Interventional Fluoroscopic X-Ray System Artis icono biplane- 11327600 Artis icono floor, distributed nationwide in the US. The recall was initiated on 19 Mar 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSoftware VE20C serial #s 180062 170319 180317 180072 180060 180048 180083 180315 170305 180080 180301 180305 180330 170307 180040 180333 170309 170310 170304 180316 180334 170025 180047 180085 180331 180321 180309 170312 180323 164703 170303 180329 180015 180014 180037

Quantity recalled133 systems

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-1497-2021
FDA event ID: 87620
Recalling firm: Siemens Medical Solutions USA, Malvern, PA
Classification: Class II
Status: Terminated
Recall initiated: 19 Mar 2021
FDA classified: 26 Apr 2021
Reported: 5 May 2021
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Imaging Equipment

Timeline

19 Mar 2021	Recall initiated by company
26 Apr 2021	Classified by FDA	+38 days
5 May 2021	Published in enforcement report	+9 days

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

Reason for recall

Siemens has become aware of a potential issue with software version VE20C. Planned procedures may have to be terminated and performed on an alternative x-ray system.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

Interventional Fluoroscopic X-Ray System ARTIS icono biplane- 11327600 ARTIS icono floor- 11327700 ARTIS pheno- 10849000 ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.

Where it was distributed

Worldwide distribution: US (nationwide) including states of: CA, CO, DE, FL, IL, IN, KY, MD, MI, NC, NE, NJ, NY, OH, TN, TX, UT, WI, and OUS (countries) of: AT, BE, ES, IT, FI, CH, FR, GB, SE, DE, DK, IE and NL.

Nationwide California Colorado Delaware Florida Illinois Indiana Kentucky Maryland Michigan North Carolina Nebraska New Jersey New York Ohio Tennessee Texas Utah Wisconsin

Questions about this recall

Is Interventional Fluoroscopic X-Ray System Artis icono biplane- 11327600 Artis icono floor recalled?

Yes. Siemens Medical Solutions USA recalled Interventional Fluoroscopic X-Ray System Artis icono biplane- 11327600 Artis icono floor on 19 Mar 2021. The recall is Class II and its status is Terminated. Recall number Z-1497-2021.

Why was it recalled?

Siemens has become aware of a potential issue with software version VE20C. Planned procedures may have to be terminated and performed on an alternative x-ray system.

Which lots are affected?

Software VE20C serial #s 180062 170319 180317 180072 180060 180048 180083 180315 170305 180080 180301 180305 180330 170307 180040 180333 170309 170310 170304 180316 180334 170025 180047 180085 180331 180321 180309 170312 180323 164703 170303 180329 180015 180014 180037

Where was it sold?

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.

Reported	Class	Recall	Company	Reason	Where
8 Jul 2026Device	CLASS II	Artis icono ceiling recalled by Siemens Medical Solutions USA	Siemens Medical Solutions USA	Other	Nationwide
8 Jul 2026Device	CLASS II	Artis icono biplane recalled by Siemens Medical Solutions USA	Siemens Medical Solutions USA	Other	Nationwide
8 Jul 2026Device	CLASS II	Artis icono floor recalled by Siemens Medical Solutions USA	Siemens Medical Solutions USA	Other	Nationwide
8 Jul 2026Device	CLASS II	Artis icono ceiling recalled by Siemens Medical Solutions USA	Siemens Medical Solutions USA	Other	Nationwide
10 Jun 2026Device	CLASS II	Artis pheno recalled by Siemens Medical Solutions USA	Siemens Medical Solutions USA	Other	PA

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