Artis Q and Q.Zen fluoroscopic x-ray system
Medical device recall Z-1466-2017. Published in FDA’s Enforcement Report on Mar 22, 2017.
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 22, 2017. 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
- 2,158 units distributed in US and 6,139 units worldwide 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 gap in the housing of the wireless foot switch could potentially result in liquids penetrating the interior. Such liquids may include disinfectants, cleaning agents and/ or bodily fluids. In rare cases, the introduction of liquids in the wireless foot switch housing could result in the failure of the foot switch.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Artis Q and Q.Zen fluoroscopic x-ray system
2,158 units distributed in US and 6,139 units worldwide, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Device Model: 4787797 Serial Numbers: 15260 20888 1104 20249 15197 10252 20019 20613 15508 10234 20425 21143 22191 20124 20369 20681 22147 21346 1260 10127 10107 10100 15238 20128 21959 21966 21217 1204 21419 20721 21235 22085 1129 20627…
Every code shown here, 1,997 characters
Device Model: 4787797 Serial Numbers: 15260 20888 1104 20249 15197 10252 20019 20613 15508 10234 20425 21143 22191 20124 20369 20681 22147 21346 1260 10127 10107 10100 15238 20128 21959 21966 21217 1204 21419 20721 21235 22085 1129 20627 20637 1294 1295 20240 21439 20715 1444 20983 22439 20171 1085 21885 1119 17109 15692 1065 17227 17223 21622 10008 10094 20432 21722 1801 22421 10275 10462 20134 1673 15126 15152 20521 21887 21448 20131 22038 21710 20723 1356 1347 10006 17174 10115 22103 22154 17050 21006 20381 15028 15518 22344 21095 20693 20801 20802 20394 1279 10059 10084 15268 21857 20349 21000 1196 15291 20000 22113 15432 20923 20829 17182 17110 21913 21954 22150 17073 17160 20200 21823 20567 17099 21291 20420 20976 20399 1262 150099 20183 21564 20281 10451 15393 20684 20423 20083 20503 21025 20130 22098 15330 15079 20349 21810 21811 21850 21865 20125 21216 17211 20986 20445 20631 21972 21975 22140 10422 21889 20404 20239 21060 1051 1105 20388 1369 10095 17451 20642 10152 15053 20253 17337 22144 22354 20116 20551 21828 17535 21594 10192 20636 10118 10022 10029 10036 20885 21151 21442 21608 1687 21286 21065 1570 21382 21347 15148 21768 22301 22444 17485 20860 22161 21001 15230 17531 15124 22274 20462 21500 20113 21569 15200 20851 20290 20869 20437 15122 20079 1229 1790 20329 20314 21195 1127 1341 1533 15604 17541 1869 20008 21352 21630 15065 15620 1252 17078 15011 20576 10468 17547 21033 22442 20734 17003 17071 21163 20773 20775 20779 20362 20358 20611 10128 17319 21557 21706 21555 21730 1578 20495 1132 10382 21216 20066 21230 21347 17592 20020 17053 20114 20008 10104 22323 20005 21064 15060 21331 1654 20747 1159 15320 21381 21893 15116 17411 15624 17143 17515 1671 15119 15056 20828 21200 22321 22008 21035 1446 10068 20301 21539 17365 1059 1283 15234 10342 1741 10348 1693 1723 20507 21808 15258 10436 21469 17098 22062 10454 10139 1561 17544 21231 21181 21780 20227 15361 1266 22055 21827 1696 1246 1282 1728 20710 20480 10125 15593 20313 15143 15001 15321 20133…
FDA’s list runs to 12,727 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.
Distributed 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?
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 27, 2017.
- FDA classified it on Mar 14, 2017.
- FDA’s Enforcement Report published it on Mar 22, 2017.
- FDA terminated it on Jan 14, 2019.
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 12,727 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.