Artis Q Biplane
Medical device recall Z-1495-2020. Published in FDA’s Enforcement Report on Mar 25, 2020.
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 Mar 25, 2020. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 1452 worldwide (638 US) 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?
A software issue could potentially cause the stand and table movements to be blocked.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Artis Q Biplane, Model No. 10848282; Artis Q Ceiling, Model No.10848281; Artis Q Floor, Model No. 10848280; Artis Q zeego, Model No. 10848283 Product Usage: Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
1452 worldwide (638 US), in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial numbers: 117316 109490 117021 121396 121185 121430 117012 121406 109141 109502 109123 121336 109400 109210 121089 109080 103061 109190 109191 109197 109198 121013 117136 117324 109418 109419 109421 121040 109405 109437 109119 109346…
Every code shown here, 1,997 characters
Serial numbers: 117316 109490 117021 121396 121185 121430 117012 121406 109141 109502 109123 121336 109400 109210 121089 109080 103061 109190 109191 109197 109198 121013 117136 117324 109418 109419 109421 121040 109405 109437 109119 109346 121445 121082 109460 121459 121011 109137 109512 117108 109300 121371 109187 121134 121374 109228 109412 109066 109067 109068 121053 121054 121422 117001 117023 109133 109134 121014 121112 121209 121325 109365 109217 109366 121357 109203 121051 109496 117330 109367 121402 103258 109542 121004 121167 121378 117329 121369 117315 121133 121163 121364 109202 121018 121154 121351 121354 117125 121418 121442 121151 121036 109500 117006 109451 121205 121340 121365 121137 109526 103013 109431 109383 121078 103053 121216 103035 109015 109136 117312 109132 117018 117124 109211 109144 109413 109482 109332 121381 109536 121457 121460 121352 121421 109309 117129 109488 117112 109304 109168 109520 121434 121165 121010 109501 121171 109162 109485 109507 109038 121210 121215 109040 109457 109183 121366 103285 103286 117020 109181 121370 121391 121384 109064 109009 121472 109226 109219 117030 109321 103230 121405 109330 103277 109452 121342 121301 109414 109380 121081 109076 109435 109179 109434 121424 109424 121315 109188 117029 103001 103239 109357 109432 117123 121355 109532 109071 109072 109075 109231 109355 109503 121179 117100 121140 121416 109090 121470 121417 109311 121106 109041 121411 109164 109167 121120 117134 117307 109373 109146 121144 121383 117117 109429 121047 117111 121312 117304 117024 121027 121359 121136 103028 121175 117127 121439 121173 121462 117325 109032 109463 109415 117303 117310 109524 121419 121435 121468 109461 121008 121152 109048 121155 121160 109301 109020 109036 109043 121433 121449 109336 109480 109320 109104 121379 109361 117314 121319 117309 121058 117113 117322 109158 117014 109031 117040 121211 117041 109318 109402 121375 121377 109010 121393 121071 117114 109349 109456 121034 117009 109069 109391 109416…
FDA’s list runs to 2,135 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 distribuiton.
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?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, 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 14, 2020.
- FDA classified it on Mar 13, 2020.
- FDA’s Enforcement Report published it on Mar 25, 2020.
- FDA terminated it on Apr 20, 2021.
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 2,135 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.