Artis zee ceiling
Medical device recall Z-0968-2022. Published in FDA’s Enforcement Report on Apr 27, 2022.
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 Apr 27, 2022. 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
- 709 systems 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?
If the coolant level in the cooling circuit drops below a certain level, this may result in a situation in which the X-ray tube is no longer sufficiently cooled and the system will display the message “TUBE HOT, have a break”. Several minutes later the system will block X-ray to prevent further damage and display the message “NO XRAY: TUBE TOO HOT”.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Artis zee ceiling, Model Number 10094137
709 systems, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
UDI: 4056869010052; Serial Numbers: 146669 146877 146996 146663 147100 146286 146292 146410 146676 148281 148299 147155 147678 146406 146407 146411 146166 147762 146121 147885 146710 125115 125276 125262 146945 125253 125213 125238 125245…
Every code shown here, 1,996 characters
UDI: 4056869010052; Serial Numbers: 146669 146877 146996 146663 147100 146286 146292 146410 146676 148281 148299 147155 147678 146406 146407 146411 146166 147762 146121 147885 146710 125115 125276 125262 146945 125253 125213 125238 125245 147189 147190 146679 150011 146766 148429 125265 146232 147573 148454 147996 146408 146409 146728 148498 147889 146335 148404 146659 148499 148235 147909 147833 147847 147888 146898 148402 148333 150002 147273 125105 125106 147761 146814 146871 147783 147891 147581 147857 147882 146899 146368 146643 125100 147608 147983 146650 146361 146365 146366 146369 146912 146116 146164 146168 150017 147604 147079 125216 125202 125209 147371 146156 146343 148401 148486 148487 148488 148485 147899 147129 146260 146277 125013 147760 147923 147636 147081 146235 148423 146868 148422 148509 146758 146818 146741 146174 125255 147507 147047 147667 147679 148348 147685 125011 125111 147803 146173 146176 146186 146187 146189 146630 147630 146266 125249 125281 125286 125278 146305 146908 125241 148349 148384 146267 146219 146272 146274 147096 125022 147912 148260 148335 148390 146298 147982 146637 125268 147841 147078 146327 146333 146338 147786 148465 147924 147023 148220 125211 147910 148288 147919 147921 125021 148463 148490 146851 147514 147954 146688 147918 148393 148513 146144 148250 125256 147188 146324 147925 147926 147928 147558 146715 146293 125267 125269 146308 147105 147955 147956 147957 147958 148001 146825 146827 146828 147304 148277 146937 147024 146946 146334 125222 125700 125005 147953 146322 146888 147585 147553 125230 146732 146857 147736 148027 147645 148215 148216 147906 146738 146795 147164 147974 148408 125226 148298 125118 125705 148025 147087 146742 146169 125204 147972 148426 148030 125260 148351 147992 146921 146263 146781 147938 148282 146721 146724 146860 146393 148481 148411 148418 125024 147035 125009 147196 146323 146150 146812 146635 147583 146354 147852 147025 146251 146238 146388 148503 146382 125113 146755 146756…
FDA’s list runs to 5,039 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.
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?
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 Feb 23, 2022.
- FDA classified it on Apr 21, 2022.
- FDA’s Enforcement Report published it on Apr 27, 2022.
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 5,039 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.