Artis zee biplane
Medical device recall Z-2031-2019. 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
- 268 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 biplane, Model Number 10094141
268, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Numbers: 153131 153229 153172 153315 153317 153992 153335 153695 153101 153102 153717 153779 153280 153648 153674 153166 153700 154096 153834 153194 153169 153803 153110 153890 154157 153199 153887 153269 154074 154012 153191 153252…
Every code shown here, 1,891 characters
Serial Numbers: 153131 153229 153172 153315 153317 153992 153335 153695 153101 153102 153717 153779 153280 153648 153674 153166 153700 154096 153834 153194 153169 153803 153110 153890 154157 153199 153887 153269 154074 154012 153191 153252 153732 153239 154090 153227 153889 153655 153234 153236 153285 154686 153273 153251 153254 153344 154095 153342 154093 153171 153197 153916 153831 153256 153154 154086 153139 153882 153311 153211 153118 153987 153740 153863 153772 154079 153965 153707 154098 154073 153263 153276 154076 153758 131013 153257 154156 153351 153112 153155 153245 153318 153720 153998 153271 153857 153226 153939 153951 153290 153678 153679 153277 153125 153128 153134 153135 153743 153967 153946 153145 153866 153868 153829 153148 131021 153878 153906 153959 153709 153767 153217 153639 153119 153164 153304 153869 153719 153232 131005 153770 154020 153930 153728 153355 154058 153811 153225 154155 153883 153875 153289 153664 153963 153824 154034 154018 153356 153701 153113 153235 153347 153708 153338 154066 153259 153314 154014 153988 154048 153716 153215 153922 153870 153107 153178 153249 153706 153860 153264 153157 153903 153908 153819 154087 153914 154085 153156 153697 131000 153147 153790 153928 153864 153159 153756 153808 154052 153797 153634 154028 154084 153201 153865 153640 153714 153736 153832 153913 153348 153220 153947 153657 153873 153109 153150 153299 153757 153898 154075 154064 153111 153618 153689 154044 153847 154056 154035 153999 153124 153682 153120 153122 153329 153173 153763 153686 154100 154082 153617 153327 153180 153818 154007 153323 154055 154067 154088 131020 153762 153270 153862 153670 153607 153760 154094 153265 153694 153886 153332 153141 153195 153920 153343 153975 153993 153325 153631 153160 153186 153729 154089 153354 153684 153799 154041 153742 153952 154077 153214 153722 153206 153255 154097 153115 153744 153827 153671
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.”
- 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.