CLASS II Device recall · Reported 6 Sep 2017 · FDA Enforcement Report

Artis zee/zeego and Artis Q/Q.zen system, x-ray recalled

Siemens Medical Solutions USA is recalling Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic Axiom Artis zee and Q/Q.zen, distributed nationwide in the US. The recall was initiated on 18 Feb 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesArtis zee ceiling - Serial number: 146996 147100 147233 147049 147678 147763 147803 147885 147084 147190 147189 147573 147889 146993 147909 147833 147847 147888 146965 147273 147761 147030 147239 147783 147891 146988 147677 147882 147562 147608 146980 147036 147581 147857 125001 147604 147371 147899 147129 147210 147923 147760 147636 147081 147267 147047 147679 147667 125002 147685 125011 147042 147630 147835 147208 147247 147096 147912 147515 147236 147175 146972 147841 147078 147924 147023 147910 147934 147921 147919 147255 147249 147514 147954 147918 147165 147188 147926 147928 147925 147558 146968 147956 147958 147957 147955 147304 147944 147024 147724 125005 147172 147585 147553 147736 147645 147906 147164 147974 147087 147972 146856 146921 147938 125006 147193 147196 147025 147583 147852 147044 147814 147203 147601 147659 147894 147675 147098 147905 147113 147516 147107 147700 147167 147702 147935 147500 147121 147969 147745 147898 147936 147106 147850 147681 147795 147845 146855 146957 147652 147773 147243 125010 147827 147789 147878 147877 147541 147831 147124 147119 147120 147144 147237 147240 147709 147577 147896 147268 147168 147029 125004 147587 147285 147612 147880 147526 147625 147635 146987 146983 146975 147296 147171 147695 146971 146969 146973 147200 147733 147059 147177 147238 147692 147693 147753 147241 147089 146919 147821 147009 147648 147114 147216 147866 147214 146963 147373 147123 147762 147174 147668 147083 147755 147673 147887 147800 146964 147816 147815 147561 147155 147939 147771 147665 147657 146991 146857 147867 147871 147813 147088 147660 147649 147093 147264 147364 125003 147075 147775 147790 125000 147781 147839 147862 147655 147734 147900 147079 147643 147748 146960 147027 147559 147620 146982 147715 147287 147507 147838 147749 147633 147881 147737 147621 147205 147250 147254 147253 147252 147251 125008 147893 147676 147717 147778 147952 147931 147933 146929 146925 147927 147799 147365 147157 147892 147662 146927 147207 147646 147670 147234 147552 147295 147046 147644 147701 147666 147557 147661 147307 147766 147971 147718 147917 147103 147303 147849 147842 147265 147301 147235 147094 147716 147739 147743 147752 147937 147031 147746 147528 147656 147940 146977 147687 147109 147863 147186

Quantity recalled986 units in USA

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-3094-2017
FDA event ID: 77908
Recalling firm: Siemens Medical Solutions USA, Malvern, PA
Classification: Class II
Status: Terminated
Recall initiated: 18 Feb 2016
FDA classified: 29 Aug 2017
Reported: 6 Sep 2017
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Imaging Equipment

Timeline

18 Feb 2016	Recall initiated by company
29 Aug 2017	Classified by FDA	+558 days
6 Sep 2017	Published in enforcement report	+8 days

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

Reason for recall

Due to a leak in the cooling system, fluids could potentially seep into the equipment cabinet. Loss of coolant can results in a cooling system failure and subsequent system failure. This leek can occur sporadically in affected systems.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and Q/Q.zen 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. Procedures that can be performed with the AXIOM Artis-zee/zeego and Q/Q.zen family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. AXIOM Artis zee/zeego and Q/Q.zen can also support the acquisition of position triggered imaging for spatial data synthesis

Where it was distributed

Nationwide Distribution

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

Artis zee ceiling - Serial number: 146996 147100 147233 147049 147678 147763 147803 147885 147084 147190 147189 147573 147889 146993 147909 147833 147847 147888 146965 147273 147761 147030 147239 147783 147891 146988 147677 147882 147562 147608 146980 147036 147581 147857 125001 147604 147371 147899 147129 147210 147923 147760 147636 147081 147267 147047 147679 147667 125002 147685 125011 147042 147630 147835 147208 147247 147096 147912 147515 147236 147175 146972 147841 147078 147924 147023 147910 147934 147921 147919 147255 147249 147514 147954 147918 147165 147188 147926 147928 147925 147558 146968 147956 147958 147957 147955 147304 147944 147024 147724 125005 147172 147585 147553 147736 147645 147906 147164 147974 147087 147972 146856 146921 147938 125006 147193 147196 147025 147583 147852 147044 147814 147203 147601 147659 147894 147675 147098 147905 147113 147516 147107 147700 147167 147702 147935 147500 147121 147969 147745 147898 147936 147106 147850 147681 147795 147845 146855 146957 147652 147773 147243 125010 147827 147789 147878 147877 147541 147831 147124 147119 147120 147144 147237 147240 147709 147577 147896 147268 147168 147029 125004 147587 147285 147612 147880 147526 147625 147635 146987 146983 146975 147296 147171 147695 146971 146969 146973 147200 147733 147059 147177 147238 147692 147693 147753 147241 147089 146919 147821 147009 147648 147114 147216 147866 147214 146963 147373 147123 147762 147174 147668 147083 147755 147673 147887 147800 146964 147816 147815 147561 147155 147939 147771 147665 147657 146991 146857 147867 147871 147813 147088 147660 147649 147093 147264 147364 125003 147075 147775 147790 125000 147781 147839 147862 147655 147734 147900 147079 147643 147748 146960 147027 147559 147620 146982 147715 147287 147507 147838 147749 147633 147881 147737 147621 147205 147250 147254 147253 147252 147251 125008 147893 147676 147717 147778 147952 147931 147933 146929 146925 147927 147799 147365 147157 147892 147662 146927 147207 147646 147670 147234 147552 147295 147046 147644 147701 147666 147557 147661 147307 147766 147971 147718 147917 147103 147303 147849 147842 147265 147301 147235 147094 147716 147739 147743 147752 147937 147031 147746 147528 147656 147940 146977 147687 147109 147863 147186

Where was it sold?

Nationwide 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 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

11 other products · FDA event 77908

This product is part of a recall event; the main page for the event is Artis zee/zeego and Artis Q/Q.zen system, x-ray recalled.

Reported	Class	Recall	Company	Reason	Where
6 Sep 2017	CLASS II	Artis zee/zeego and Artis Q/Q.zen system, x-ray recalled	Siemens Medical Solutions USA	Packaging Defects	Nationwide
6 Sep 2017	CLASS II	Artis zee/zeego and Artis Q/Q.zen system, x-ray recalled	Siemens Medical Solutions USA	Packaging Defects	Nationwide
6 Sep 2017	CLASS II	Artis zee/zeego and Artis Q/Q.zen system, x-ray recalled	Siemens Medical Solutions USA	Packaging Defects	Nationwide
6 Sep 2017	CLASS II	Artis zee/zeego and Artis Q/Q.zen system, x-ray recalled	Siemens Medical Solutions USA	Packaging Defects	Nationwide
6 Sep 2017	CLASS II	Artis zee/zeego and Artis Q/Q.zen system, x-ray recalled	Siemens Medical Solutions USA	Packaging Defects	Nationwide
6 Sep 2017	CLASS II	Artis zee/zeego and Artis Q/Q.zen system, x-ray recalled	Siemens Medical Solutions USA	Packaging Defects	Nationwide
6 Sep 2017	CLASS II	Artis zee/zeego and Artis Q/Q.zen system, x-ray recalled	Siemens Medical Solutions USA	Packaging Defects	Nationwide
6 Sep 2017	CLASS II	Artis zee/zeego and Artis Q/Q.zen system, x-ray recalled	Siemens Medical Solutions USA	Packaging Defects	Nationwide
6 Sep 2017	CLASS II	Artis zee/zeego and Artis Q/Q.zen system, x-ray recalled	Siemens Medical Solutions USA	Packaging Defects	Nationwide
6 Sep 2017	CLASS II	Artis zee/zeego and Artis Q/Q.zen system, x-ray recalled	Siemens Medical Solutions USA	Packaging Defects	Nationwide
6 Sep 2017	CLASS II	Artis zee/zeego and Artis Q/Q.zen system, x-ray recalled	Siemens Medical Solutions USA	Packaging Defects	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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