System Material # Artis zee floor 10094135 Artis zee ceiling 10094137 Artis zee multi-purpose 10094139 Artis…
Medical device recall Z-1040-2023. Published in FDA’s Enforcement Report on Feb 8, 2023.
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 Feb 8, 2023. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 609 US; 1627 worldwide 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?
In rare cases, the system may only boot into backup mode after an abrupt shutdown and not reach full operating mode. This may result in a situation where it is necessary to cancel clinical treatment or to continue treatment on an alternative system.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
System Material # Artis zee floor 10094135 Artis zee ceiling 10094137 Artis zee multi-purpose 10094139 Artis zee biplane 10094141 Artis zeego 10280959 Artis Q floor 10848280 Artis Q ceiling 10848281 Artis Q biplane 10848282 Artis Q.zeego 10848283 Artis Q.zen floor 10848353 Artis Q.zen ceiling 10848354 Artis Q.zen biplane 10848355 Fluoroscopic X-Ray System
609 US; 1627 worldwide, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Artis zee floor UDI-DI 4056869010045 Serial Numbers 138481 124714 138390 138497 124709 124395 138102 138071 124383 124706 137617 137607 139133 137752 137736 138325 138358 139120 124378 124713 139127 138397 138367 124703 138070 124388…
Every code shown here, 1,994 characters
Artis zee floor UDI-DI 4056869010045 Serial Numbers 138481 124714 138390 138497 124709 124395 138102 138071 124383 124706 137617 137607 139133 137752 137736 138325 138358 139120 124378 124713 139127 138397 138367 124703 138070 124388 124708 139012 139023 124724 138340 138051 Artis zee ceiling UDI-DI 4056869010052 Serial numbers 150011 150062 148498 150060 150002 147983 150017 148486 148487 148488 125716 148260 148288 147954 125267 125269 147956 147958 147957 147955 148001 148277 125700 147974 150040 125705 147969 148270 150036 150005 148019 147120 147119 148361 150023 148479 147114 125257 125119 148431 148474 150009 150015 148029 147952 148484 148466 148489 125715 150003 150046 150047 125254 148240 148239 Artis zee multi-purpose UDI-DI 4056869010076 Serial numbers 159088 159190 158650 158652 158742 159124 130241 159157 159030 159085 159117 130714 159034 158225 159156 159038 159181 159032 159046 158183 159175 158272 159054 159099 158519 159177 158495 159015 159127 159058 159028 158744 159147 159037 158206 159132 159026 130708 158180 159041 159176 159042 159152 158638 130720 159158 158597 159168 158211 158458 159180 159047 159025 159024 159192 159021 130715 158468 158678 159182 159148 158786 159113 158658 159102 159100 159080 159079 158510 158227 159049 159065 157702 158599 159010 Artis zee biplane UDI-DI 4056869010069 Serial numbers 154827 155265 131707 155151 156011 154794 156014 154799 154814 155131 155310 155266 131247 155286 153999 131252 Artis zeego UDI-DI 4056869010083 Serial numbers 161226 161008 161021 161051 161209 161022 161233 161224 Artis Q floor UDI-DI 4056869009971 Serial numbers 103218 104049 104007 104016 104005 104061 104027 132508 132510 104051 103030 103258 104012 103384 104029 104020 103008 104025 103222 132507 103230 104047 104062 104013 132502 132509 132500 103048 132000 103245 103348 Artis Q ceiling UDI-DI 4056869009988 Serial numbers 110199 110088 110059 110223 110103 133503 110035 110166 110046 110005 109812 109727 110058 110156 110176…
FDA’s list runs to 4,885 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.
Worldwide - US 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.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, 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 Dec 16, 2022.
- FDA classified it on Jan 30, 2023.
- FDA’s Enforcement Report published it on Feb 8, 2023.
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 4,885 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.