Artis zee ceiling
Medical device recall Z-2029-2019. Published in FDA’s Enforcement Report on Jul 31, 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 31, 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
- 428 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 tolerance issue in the power supply of the generator control above a specific value may cause generator A100 failure. As a result, the X-ray tube will not be supplied with the required voltage and X-ray will not be possible. The issue occurs sporadically; however, it may occur during an on-going procedure.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Artis zee ceiling, Model Number 10094137
428, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Numbers: 146669 146877 146996 146663 147100 146286 146292 146410 146676 147155 147049 147233 146406 146407 146411 146121 146710 146945 147084 147189 147190 146679 146766 146232 146408 146409 146728 146335 146659 146993 146898 146965…
Every code shown here, 1,997 characters
Serial Numbers: 146669 146877 146996 146663 147100 146286 146292 146410 146676 147155 147049 147233 146406 146407 146411 146121 146710 146945 147084 147189 147190 146679 146766 146232 146408 146409 146728 146335 146659 146993 146898 146965 146221 147273 146814 146871 146952 147030 147239 146988 146899 146368 146643 146650 146980 146361 146365 146366 146369 146912 147036 146116 146164 146168 147079 147371 146156 146342 146343 147129 146192 147081 146235 146201 146260 146277 146868 146758 146818 146741 146174 147507 146245 147047 125002 146171 146173 146176 146186 146187 146188 146189 147042 146630 146266 146305 146908 146267 147208 147247 146219 146272 146274 147096 125022 147236 146193 146761 147175 146298 146637 146972 147078 146976 146652 146327 146333 146338 147786 147023 146851 147249 147255 146688 146166 146144 147165 147188 146324 146715 146293 146308 146968 147105 146825 146827 146828 146829 147304 146937 146946 147024 146334 125005 146322 146888 147172 146136 146738 146795 147164 146395 147378 147087 146742 146169 146856 146921 146263 146781 146721 146724 146860 146393 147035 125009 147193 147196 146986 146323 146150 146812 146241 146242 146635 147025 146354 147044 146251 146727 146238 146388 146382 147814 146753 146755 146756 147203 146119 146264 146618 147098 146139 147113 146656 147107 146942 146886 147167 146733 147121 146612 147106 146731 146809 146394 146846 146855 146940 146957 147243 146918 146709 147831 147119 147120 147124 146901 147144 147237 147240 146863 146934 146806 146935 147268 146798 147168 147029 125004 146619 146205 146803 147285 146722 146717 146774 146690 146691 146218 146987 146786 146424 146983 146152 146975 146137 146279 146289 146750 147296 147171 146184 147210 146775 146776 146969 146971 146973 147200 146345 147067 125016 147059 147177 146872 146784 146932 146397 147238 146887 147241 146711 147089 146233 146170 146220 146919 146257 147009 146183 147114 146839 146178 147214 147216 146963 147373 147123 146212 146895 146909 146627…
FDA’s list runs to 3,011 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 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 Jun 12, 2019.
- FDA classified it on Jul 22, 2019.
- FDA’s Enforcement Report published it on Jul 31, 2019.
- FDA terminated it on Sep 18, 2020.
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 3,011 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
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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.