Artis zee Biplane
Medical device recall Z-1497-2020. Published in FDA’s Enforcement Report on Mar 25, 2020.
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 Mar 25, 2020. 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
- 1452 worldwide (638 US) 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?
A software issue could potentially cause the stand and table movements to be blocked.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Artis zee Biplane, Model No. 10094141; Artis zee Ceiling, Model No. 10094137; Artis zee Floor, Model No. 10094135; Artis zeego, Model No. 10280959 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.
1452 worldwide (638 US), in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Numbers 154827 160851 148262 155168 154408 148299 137623 137714 125213 125238 125245 160869 147573 126202 161046 161041 154454 153834 147581 147857 147562 154532 147983 161218 160999 161032 161204 125001 161226 147604 153890 154721…
Every code shown here, 1,995 characters
Serial Numbers 154827 160851 148262 155168 154408 148299 137623 137714 125213 125238 125245 160869 147573 126202 161046 161041 154454 153834 147581 147857 147562 154532 147983 161218 160999 161032 161204 125001 161226 147604 153890 154721 154722 137193 138055 147760 147923 160449 160834 160852 138035 160944 137479 146245 160994 154567 160959 147803 125249 125241 154704 160913 148260 138087 160886 148335 154086 138112 161206 147841 155189 154727 147954 147918 160877 161008 148250 160997 147558 160864 160845 160448 138147 147955 147957 147958 160965 160800 154509 147724 138102 161236 125222 147953 137388 147553 131219 160823 147736 148215 148216 147974 154792 148298 137766 148025 160431 147972 137595 160916 137335 148282 160814 160872 146323 147992 147601 147659 147894 148010 147905 160915 125229 137421 131221 147249 153743 161021 147500 147969 148270 137119 147936 154683 160989 160501 161051 147681 147795 147845 160874 147652 161223 154653 154671 161007 154556 160862 160860 147541 147709 125223 161010 147587 154633 154020 147612 148022 160854 160429 137736 137752 138194 160149 154579 160878 148011 154560 155131 155191 125240 160856 153338 125208 125239 131223 154663 138005 160953 160903 138104 137656 138119 154592 131224 161005 160861 154684 160889 160813 161209 147668 160998 155195 137296 138015 160914 148352 147800 148254 148318 154471 148243 125210 154456 137229 147771 147944 161022 154546 161215 148278 148326 147988 147075 125201 125233 147839 161217 147655 147900 160940 148316 148273 160876 154678 148341 125214 148307 160885 155159 147287 161000 125227 125228 148207 148029 161050 124286 147717 154770 147952 148230 160825 148236 160850 155118 160942 148021 160873 161233 161234 125232 160840 147670 160956 161016 161017 147307 147718 148327 148375 154739 155150 160413 160414 160996 146705 160509 161004 160978 147301 147235 160551 148263 125244 160807 138051 161224 147937 147746 147528 147656 161235 148242 153744 ***Added 11/2/20*** 153640 146855 160493 154572…
FDA’s list runs to 2,008 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.
US Nationwide distribuiton.
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 14, 2020.
- FDA classified it on Mar 13, 2020.
- FDA’s Enforcement Report published it on Mar 25, 2020.
- FDA terminated it on Apr 20, 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.”
- FDA’s list of codes runs to 2,008 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.