Artis zeego, Model Number 10280959
Medical device recall Z-0973-2022. 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
- 183 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 zeego, Model Number 10280959
183 systems, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
UDI: 4056869010083; Serial Numbers: 160851 160879 161046 160395 160484 161041 160351 161218 160999 161032 161204 161226 160838 160449 160852 160463 160411 160106 160134 160136 160953 160347 160913 161206 160961 160312 160877 161008 160488…
Every code shown here, 1,357 characters
UDI: 4056869010083; Serial Numbers: 160851 160879 161046 160395 160484 161041 160351 161218 160999 161032 161204 161226 160838 160449 160852 160463 160411 160106 160134 160136 160953 160347 160913 161206 160961 160312 160877 161008 160488 160997 160864 160448 160937 160965 160427 160455 160884 160486 161236 160435 160451 160823 160951 160384 160431 160100 160916 160814 160872 160391 160470 160321 160376 160915 160447 161021 160481 160401 160119 160403 160404 160871 160989 161051 160874 161223 161007 160862 160438 160860 160378 160419 160889 160450 160854 160429 160149 160878 160137 160152 160153 160154 160138 160446 160368 160957 160992 160394 160856 160432 160147 160433 160483 160402 161005 161209 160813 160998 160356 160425 160148 160337 160460 160485 160443 160370 160912 160381 160412 161215 160919 161217 160407 160876 160861 160325 160885 160910 161000 160494 160390 161050 160507 160144 160833 160001 160363 160825 160341 160139 160942 160816 160430 160873 161233 161234 160840 160006 160462 160505 160956 160445 160322 160323 160382 160421 160474 160428 160116 161016 161017 160131 160318 160369 160498 160413 160414 160128 160373 161004 160978 160551 160327 160865 160830 161224 161235 160338 160141 Additional Serial Numbers as of 10/4/23: 160501 160519 160406 160900 160850 160959 160461 160903 126206 160905 160930 160967 160925 160469
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.”
- 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.