Artis zee/zeego and Artis Q/Q.zen system, x-ray, angiographic AXIOM Artis zee and Q/Q.zen is a family of…
Medical device recall Z-3094-2017. Published in FDA’s Enforcement Report on Sep 6, 2017.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Sep 6, 2017. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 986 units in USA how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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
986 units in USA, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 1,995 characters
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…
FDA’s list runs to 2,260 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Nationwide Distribution
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Feb 18, 2016.
- FDA classified it on Aug 29, 2017.
- FDA’s Enforcement Report published it on Sep 6, 2017.
- FDA terminated it on Nov 17, 2017.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Siemens Medical Solutions USA, Inc, of Malvern, PA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 2,260 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.