Siemens Artis zee ceiling -Interventional Fluoroscopic X-Ray System
Medical device recall Z-1895-2019. Published in FDA’s Enforcement Report on Jul 10, 2019.
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 Jul 10, 2019. 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
- 276 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?
Artis Zee, Artis Q, Artis Pheno or Artis Icono systems equipped with a DCS Extended or DCS Movable, the potential exists for individual screws of the screwed connection joining the pivot bearing to the ceiling-mounted support to work loose or snap off, can result in severe injuries to patients and operating personnel
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Siemens Artis zee ceiling -Interventional Fluoroscopic X-Ray System Model Number: 10094137
276, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Numbers: 147208 146637 146395 146728 146942 146697 146663 146731 146945 146774 146784 146866 147186 146867 146692 146869 146759 146776 146775 146797 146871 146801 146857 146803 146886 146758 146806 146851 146929 147157 146971 146919…
Every code shown here, 1,947 characters
Serial Numbers: 147208 146637 146395 146728 146942 146697 146663 146731 146945 146774 146784 146866 147186 146867 146692 146869 146759 146776 146775 146797 146871 146801 146857 146803 146886 146758 146806 146851 146929 147157 146971 146919 146969 146973 146925 147695 146948 146964 147046 146861 147123 146883 147216 147866 146888 146955 147214 146921 147931 147100 146928 146946 147030 146983 146899 147089 146975 146963 146986 146960 146898 146937 146918 147047 146977 146993 147035 146982 147075 147084 146991 147114 147023 147233 147049 147036 147093 147009 147500 146996 147029 147174 147766 147113 147241 147083 147087 147124 147120 147119 147172 147692 147693 147775 147165 147167 147303 147079 147203 147107 147168 147144 147237 147240 147236 147239 147243 147234 147190 147175 147515 147559 147250 147254 147253 147252 147251 147649 147612 147557 147507 147516 147585 147528 147573 147264 147620 147558 147526 147604 147646 147581 147608 147849 147583 147553 147601 147659 147644 147701 147666 147635 147625 147905 147660 147842 147577 147587 147621 147670 147700 147662 147718 147737 147887 147676 147717 147783 147709 147364 125111 147734 147753 147893 147763 147956 147958 147957 147373 147955 147749 147760 147761 147821 147889 147847 147833 125003 147773 147800 147838 147816 147862 147921 147795 147926 147928 147925 147940 147880 147841 148274 147938 147891 148282 148242 148240 148239 125230 147894 147909 147882 148327 147896 147937 147892 147919 147910 147982 147923 147936 147954 147934 147952 147983 147992 125008 148375 147974 125010 125105 125106 125109 125100 148001 147977 148010 148230 125112 148022 148020 148235 148220 148029 148278 148025 148030 148285 125239 125208 125219 125212 148254 148318 148335 125115 125214 148352 148341 148326 125228 125227 125222 125210 125250 125226 125245 125254 148348 148316 125243 125240 148333 125244 125235 125232 148409 148407 148349 148384 148404 148382 148400 125253 125249 148423
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
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 Jun 6, 2019.
- FDA classified it on Jun 28, 2019.
- FDA’s Enforcement Report published it on Jul 10, 2019.
- FDA terminated it on Feb 9, 2021.
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.”
- 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
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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.