Artis Q ceiling
Medical device recall Z-0975-2022. 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
- 418 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 Q ceiling, Model Number 10848281
418 systems, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
UDI: 4056869009988; Serial Numbers: 109130 109490 109552 110088 110059 110103 133503 109799 110035 109642 109892 109135 109569 109123 110046 109400 110005 109812 109727 109210 109628 110058 109931 110056 109080 109610 110062 109074 109746…
Every code shown here, 1,996 characters
UDI: 4056869009988; Serial Numbers: 109130 109490 109552 110088 110059 110103 133503 109799 110035 109642 109892 109135 109569 109123 110046 109400 110005 109812 109727 109210 109628 110058 109931 110056 109080 109610 110062 109074 109746 109417 109479 109352 109388 109190 109191 109197 109198 109418 109419 109421 133000 133201 109305 109789 109792 109889 109592 109738 109405 109657 109119 109346 109016 109523 109645 109118 109693 109493 110067 109583 109817 109460 109137 109512 109155 109379 109681 109820 109709 110119 109187 109663 109787 109747 109228 109327 109412 109066 109067 109068 109760 110095 109084 109133 109134 110051 109833 109365 109217 109366 110001 110020 109688 109203 109367 110007 109169 109434 109589 109838 110093 109769 109660 109651 133202 110109 110128 109378 109384 109639 109598 109893 109783 110096 109621 109653 109500 109602 109748 109451 109504 109505 109143 109526 109565 109102 109431 109383 109785 109794 109407 109015 109029 109136 109442 110069 110106 109194 109132 109662 109144 109726 109413 109674 109803 109627 109772 109482 109780 110063 110042 110043 110048 110064 110032 110047 110102 109536 110039 110040 109656 109309 109779 110023 109700 110014 110110 109488 110065 133001 109848 109168 109227 109520 109467 110052 109057 109221 109484 109830 109915 109501 110018 109162 109507 109567 109103 109165 109038 109604 109040 109324 109603 110072 109741 109034 109129 109673 109668 109181 109884 109643 109620 109064 109009 109678 109219 109321 109541 110081 110036 109330 109629 109452 109076 109749 109435 109551 109652 109386 110054 109795 109179 109007 109661 109699 109613 109716 109458 109777 109229 109538 109752 109357 109659 109424 110053 109531 110107 109532 109071 109072 109075 110044 109231 109355 109543 109503 109091 110031 109300 109591 109630 109090 109631 109393 109920 109311 110016 109041 109856 109886 110037 110077 109497 109164 109167 109039 109908 109771 110079 109527 109362 109060 109762 109839 109842 109845 110099 109922…
FDA’s list runs to 3,002 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 3,002 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.