CLASS II Device recall · Reported 25 Mar 2020 · FDA Enforcement Report

Artis Q.zen Biplane recalled by Siemens Medical Solutions USA

Siemens Medical Solutions USA is recalling Artis Q.zen Biplane, distributed nationwide in the US. The recall was initiated on 14 Feb 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial Numbers 123225 105120 123026 105028 111005 111122 111124 111125 123236 111002 123053 123050 123008 123035 123003 123032 123208 123209 123231 123206 123207 123240 105025 111121 123219 111115 111116 111117 111118 111119 111120 123229 123205 123224 123232 123233 123234 123027 111107 123055 123056 105017 123010 123046 111000 111106 123052 111123 111128 123200 123015 123016 105112 ***Added 3/30/2020*** 123031 123022

Quantity recalled1452 worldwide (638 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-1496-2020
FDA event ID: 85071
Recalling firm: Siemens Medical Solutions USA, Malvern, PA
Classification: Class II
Status: Terminated
Recall initiated: 14 Feb 2020
FDA classified: 13 Mar 2020
Reported: 25 Mar 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Imaging Equipment

Timeline

14 Feb 2020	Recall initiated by company
13 Mar 2020	Classified by FDA	+28 days
25 Mar 2020	Published in enforcement report	+12 days

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

Reason for recall

A software issue could potentially cause the stand and table movements to be blocked.

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

Artis Q.zen Biplane, Model No. 10848355 Artis Q.zen Ceiling, Model No. 10848354 Artis Q.zen Floor, Model No. 10848353 Product Usage: 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

US Nationwide distribuiton.

Nationwide

Questions about this recall

Why was it recalled?

A software issue could potentially cause the stand and table movements to be blocked.

Which lots are affected?

Serial Numbers 123225 105120 123026 105028 111005 111122 111124 111125 123236 111002 123053 123050 123008 123035 123003 123032 123208 123209 123231 123206 123207 123240 105025 111121 123219 111115 111116 111117 111118 111119 111120 123229 123205 123224 123232 123233 123234 123027 111107 123055 123056 105017 123010 123046 111000 111106 123052 111123 111128 123200 123015 123016 105112 ***Added 3/30/2020*** 123031 123022

Where was it sold?

US Nationwide distribuiton.

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

Other products in this recall event

2 other products · FDA event 85071

Reported	Class	Recall	Company	Reason	Where
25 Mar 2020	CLASS II	Artis Q Biplane recalled by Siemens Medical Solutions USA	Siemens Medical Solutions USA	Device Malfunction	Nationwide
25 Mar 2020	CLASS II	Artis zee Biplane recalled by Siemens Medical Solutions USA	Siemens Medical Solutions USA	Device Malfunction	Nationwide

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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All 2,336

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