Artis Q floor
Medical device recall Z-1645-2022. Published in FDA’s Enforcement Report on Sep 7, 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 Sep 7, 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
- 1,389 (590 US; 799 OUS) (Total) 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?
Siemens has become aware of a potential hardware issue with Artis Q, Artis Q.zen, Artis pheno and Artis icono systems with a specific lot of X-ray tubes. In rare cases, if the error detection mechanism fails, it will not be possible to release X-ray any longer until system shutdown.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Artis Q floor- Model No. 10848280 Artis Q ceiling- Model No. 10848281 Artis Q biplane- Model No. 10848282 Artis Q zeego- Model No. 10848283 Artis Q.zen floor- Model No. 10848353 Artis Q.zen ceiling- Model No. 10848354 Artis Q.zen biplane- Model No. 10848355
1,389 (590 US; 799 OUS) (Total), in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Artis Q floor- Model No. 10848280 UDI-DI: 4056869009971 Serial Numbers 103221 103217 104049 103409 103232 104005 104027 132508 132510 103359 104051 103220 104029 103365 104025 103286 103222 132507 104047 132502 132509 132500 103241 103212…
Every code shown here, 1,997 characters
Artis Q floor- Model No. 10848280 UDI-DI: 4056869009971 Serial Numbers 103221 103217 104049 103409 103232 104005 104027 132508 132510 103359 104051 103220 104029 103365 104025 103286 103222 132507 104047 132502 132509 132500 103241 103212 103254 103255 ***Updated 9/23/22*** 103035 ***Updated 1/9/23*** 103444 103050 Artis Q ceiling- Model No. 10848281 UDI-DI: 4056869009988 Serial Numbers 109552 110088 110199 110059 110103 133503 110166 109123 110005 109344 109628 110058 110156 110176 110180 110147 110181 110056 110158 109074 109479 109197 109421 109792 109738 109405 110195 109437 109645 109166 110067 110161 110184 110169 110119 109747 110144 109760 110095 110167 110192 110131 109169 110093 109769 133202 109202 110109 110128 109378 109384 110096 109621 133504 110198 109015 110069 110106 110139 109211 109726 110185 110075 109674 109627 109780 110179 110063 110047 110102 109656 109309 110023 110110 110159 110065 110052 109057 109915 110191 109604 110136 110201 109457 110072 109034 109129 110145 109181 109884 109643 109678 110081 109330 109058 110182 109380 109222 109435 110054 109188 109518 109458 109155 109379 109538 109752 109659 110053 110107 109591 109630 109393 110196 110175 109920 110193 110187 110077 109164 110079 109362 109762 110099 110113 109717 110134 109564 109813 110049 110117 110066 109088 110186 109397 109685 109096 109159 110154 110183 109715 109364 110100 110129 110188 110190 109463 110083 110091 109048 109742 109301 109020 109036 109818 110115 109664 109163 109105 110055 109854 109069 109010 109756 110152 133501 109156 109157 109307 110177 110057 109391 110132 110104 110174 110149 ***Updated 9/23/22*** 110223 110227 110224 110228 109225 109358 133508 133509 ***Updated 1/9/23*** 109417 109066 110048 110014 110233 Artis Q biplane- Model No. 10848282 UDI-DI: 4056869009995 Serial Numbers 122049 121665 121564 122025 121627 121185 121336 122012 121471 121467 121612 122022 121094 122040 121006 122021 122028 121013 121501 121208 121459 121011 122037 121054…
FDA’s list runs to 3,803 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.
Worldwide Distribution: US (nationwide) and OUS (Foreign) to countries of: United Arab Emirates; Armenia; Angola; Argentina; Austria; Australia; Bangladesh; Belgium; Bulgaria; Bahrain; Brazil; Canada; Switzerland; China; Colombia; Costa Rica; Czech Republic; Germany; Denmark; Dominican Republic; Algeria; Estonia; Egypt; Spain; Finland; France; United Kingdom; Greece; Guatemala; Hong Kong; Croatia; Inhouse Company; Indonesia; Ireland; Israel; India; Iran; Italy; Jordan; Japan; South Korea; Kuwait; Kazakhstan; Lebanon; Luxembourg; Monaco; Mongolia; Martinique; Mexico; Malaysia; Netherlands; Norway; New Zealand; Oman; Philippines; Poland; Portugal; Qatar; Serbia; Russian Federation; Saudi Arabia; Sweden; Singapore; Slovenia; Slovakia; El Salvador; Thailand; Turkey; Taiwan; Ukraine; Vietnam and South Africa.
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.
The words say it went outside the United States too.
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 Aug 10, 2022.
- FDA classified it on Aug 26, 2022.
- FDA’s Enforcement Report published it on Sep 7, 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.
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 3,803 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
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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.