Artis zee multi-purpose
Medical device recall Z-0969-2022. 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
- 277 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 multi-purpose, Model Number 10094139
277 systems, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
UDI: 4056869010076; Serial Numbers: 158469 157509 158449 158467 157660 157458 130110 158474 130028 130017 158170 158650 158652 158742 158624 158583 157698 130252 158530 157532 130241 157449 158413 157657 157136 130109 157988 157690 158091…
Every code shown here, 1,995 characters
UDI: 4056869010076; Serial Numbers: 158469 157509 158449 158467 157660 157458 130110 158474 130028 130017 158170 158650 158652 158742 158624 158583 157698 130252 158530 157532 130241 157449 158413 157657 157136 130109 157988 157690 158091 158663 159034 158225 157560 130210 157436 157677 157528 159038 158422 157615 130240 157448 157165 158552 158556 158557 158561 158697 158701 159032 157977 157602 159046 157168 130212 130224 158605 158183 130253 158608 158438 130267 157642 157213 157164 158121 158619 157156 157559 157975 158670 157969 158254 158270 158272 158498 158134 158585 159054 157524 157588 158679 130102 158536 158749 158777 157750 157579 157573 157650 158216 158788 157554 157555 157671 158080 157521 158234 158566 158436 157928 158519 157696 158709 158257 158526 158569 157989 158495 159015 157488 158229 159058 158684 157999 159028 158744 130239 159037 158453 158206 158066 159026 158623 130708 157169 158220 158180 157508 157510 158032 130019 158226 157601 158244 158674 157658 157139 158617 157536 158415 157992 158578 159042 157625 157600 157604 158238 158414 158638 157565 157146 157583 158104 158105 158489 158710 158056 130217 158516 157476 157497 158597 130108 157965 130228 158448 157570 158667 158721 157505 158715 158606 157594 158410 130223 158027 158246 130220 158425 158211 158644 130234 158458 130026 158563 158042 157586 159047 157700 157907 158479 158043 130107 157414 157215 159025 158465 158746 159024 159021 158705 130225 158532 157936 157692 157984 158731 158762 158629 157409 158647 158675 158789 158416 158419 158468 159041 158739 157184 157688 158678 158786 158568 158658 157507 158490 158494 157544 158753 158763 158230 157531 157987 158510 158784 158227 158527 130275 159049 158081 158028 158407 158264 158269 158488 158426 158573 158576 158602 158207 158191 158659 158485 157704 130231 157466 158599 157442 157667 159010 158133 157438 157440 Additional Serial Numbers as of 10/4/23: 158138 159065 159085 159079 159080 159088 157674 158113 159030 157659…
FDA’s list runs to 2,015 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 2,015 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.