CLASS II Device recall · Reported 21 Oct 2020 · FDA Enforcement Report

Artis zee or Artis Q systems (listed below) recalled

Siemens Medical Solutions USA is recalling Artis zee or Artis Q systems (listed below). The recall was initiated on 3 Aug 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSoftware VD11C Patch distributed earlier via Update Instructions AX030/19/S or AX051/19/P. Serial Numbers: 103222 103285 103286 105016 109016 109021 109069 109105 109107 109158 109163 109189 109221 109300 109331 109367 109371 109393 109416 109451 109460 109504 109505 109520 111005 111104 111106 111117 111120 111123 111125 117014 117030 117117 117123 117129 117134 117303 117309 117310 117314 117325 117329 117330 121008 121058 121062 121071 121375 121377 121378 121383 121405 121417 121442 123010 123014 123023 123049 123208 123209 123233 124286 125201 125233 137245 137421 137438 137479 137729 138102 138104 138147 138156 138201 146323 147516 147612 147652 147670 147676 147724 147745 147880 147905 147923 147925 147926 147928 147944 148207 148282 148349 154532 154612 154633 154663 154739 155151 157704 158032 158458 158474 158552 160431 160449 160494 160509 160845 160850 160861 160885 160913 160942 160953 160959 160978 160999 161004 161008 161021 161050 161224 161226

Quantity recalled124 U.S

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-0108-2021
FDA event ID: 86250
Recalling firm: Siemens Medical Solutions USA, Malvern, PA
Classification: Class II
Status: Terminated
Recall initiated: 3 Aug 2020
FDA classified: 15 Oct 2020
Reported: 21 Oct 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Imaging Equipment

Timeline

3 Aug 2020	Recall initiated by company
15 Oct 2020	Classified by FDA	+73 days
21 Oct 2020	Published in enforcement report	+6 days

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

Reason for recall

Potential exists for the collision supervision not to work properly following loss of the individual room configuration data settings causing danger of collision with fix mounted room equipment, walls or floor may occur. This might cause components of the system to fall or tilt which could result in crushing of patients, operators or staff, collision of system parts with patients, as well as result in delay or interruption of the clinical procedure

Product as listed by the FDA

Artis zee or Artis Q systems (listed below) - Product Usage: for single and biplane diagnostic imaging and interventional procedures. System Name/Material Number: Artis Q BIPLANE 10848282 ARTIS Q CEILING 10848281 Artis Q floor 10848280 ARTIS Q ZEEGO 10848283 ARTIS Q.ZEN BIPLANE 10848355 ARTIS Q.zen ceiling 10848354 Artis Q.zen floor 10848353 Artis zee Biplane 10094141 Artis zee ceiling 10094137 Artis zee floor 10094135 Artis zee floor 10094135 Artis zee multi-purpose 10094139 Artis zeego 10280959

Where it was distributed

US Natonwide distribution.

Questions about this recall

Is Artis zee or Artis Q systems (listed below) recalled?

Yes. Siemens Medical Solutions USA recalled Artis zee or Artis Q systems (listed below) on 3 Aug 2020. The recall is Class II and its status is Terminated. Recall number Z-0108-2021.

Why was it recalled?

Which lots are affected?

Software VD11C Patch distributed earlier via Update Instructions AX030/19/S or AX051/19/P. Serial Numbers: 103222 103285 103286 105016 109016 109021 109069 109105 109107 109158 109163 109189 109221 109300 109331 109367 109371 109393 109416 109451 109460 109504 109505 109520 111005 111104 111106 111117 111120 111123 111125 117014 117030 117117 117123 117129 117134 117303 117309 117310 117314 117325 117329 117330 121008 121058 121062 121071 121375 121377 121378 121383 121405 121417 121442 123010 123014 123023 123049 123208 123209 123233 124286 125201 125233 137245 137421 137438 137479 137729 138102 138104 138147 138156 138201 146323 147516 147612 147652 147670 147676 147724 147745 147880 147905 147923 147925 147926 147928 147944 148207 148282 148349 154532 154612 154633 154663 154739 155151 157704 158032 158458 158474 158552 160431 160449 160494 160509 160845 160850 160861 160885 160913 160942 160953 160959 160978 160999 161004 161008 161021 161050 161224 161226

Where was it sold?

US Natonwide distribution.

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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