Artis Q and Q.zen
Medical device recall Z-0709-2018. Published in FDA’s Enforcement Report on Mar 7, 2018.
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 7, 2018. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- 51 states named in where it went
- 1557 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?
The possibility exists for the wireless foot switch to fail due to impacts by external factors, such as electrostatic discharge that exceed a certain intensity. If the foot switch fails, it will no longer be able to be used to release radiation. The hand switch provided can be used to release exposures; however, fluoroscopic examinations will not be possible.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Artis Q and Q.zen model Interventional fluoroscopic x-ray system wireless foot switch accessory; Model Numbers: 4787797, 4787805, and 4787813.
1557, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Numbers: 10000 10003 10006 10007 10008 10009 10012 10014 10020 10021 10022 10024 10025 10029 10031 10036 10038 10039 10041 10042 10045 10046 10050 10052 10056 10057 10058 1005873 10059 10070 10075 10079 10081 10095 10096 10098 10099…
Every code shown here, 2,000 characters
Serial Numbers: 10000 10003 10006 10007 10008 10009 10012 10014 10020 10021 10022 10024 10025 10029 10031 10036 10038 10039 10041 10042 10045 10046 10050 10052 10056 10057 10058 1005873 10059 10070 10075 10079 10081 10095 10096 10098 10099 10100 10107 10118 10127 10130 10133 10137 10138 10139 10140 10142 10146 10147 10152 10153 10157 10162 10163 10164 10166 10168 10179 10192 10194 10196 10197 10206 10207 10217 10226 10228 10234 10236 10237 10252 10262 10263 10264 10267 10275 10282 10288 10291 10294 10297 10298 10299 10306 10308 10314 10315 10316 10320 10322 10324 10325 10333 10342 10343 10344 10345 10346 10347 10348 10349 10352 10354 10355 10361 10365 1038 10380 10381 10382 10383 10384 10399 1040 10404 10405 10408 10418 10419 10422 10426 1043 10430 10435 10436 10438 10442 10443 10449 10451 10454 10456 1046 10462 10467 10468 10469 1051 1059 1067 1073 1080 1085 1102 1105 1108 1119 1123 11232 1127 1129 1132 1133 1134 1147 1153 1159 1164 1170 117538 1179 1180 1181 1183 1191 1202 1209 1211 1215 1229 1237 1245 1250 1257 1262 1264 1266 1269 1273 1282 1285 1290 1299 1302 1303 1314 1317 1318 1321 1341 1347 1348 1354 1356 1357 1369 1389 1390 1393 1397 1398 1402 1406 1419 1421 1427 1430 1441 1442 1444 1445 1446 1461 1465 1467 1472 1473 1475 1486 15001 15002 15003 15004 15005 150099 15011 15012 15013 15015 15020 15023 15024 15028 15033 15052 15054 15065 1507 15074 15075 15076 1508 15080 1509 1511 15111 15112 1512 15124 15127 15128 15129 15132 15134 15143 15167 15169 1517 15174 15175 15181 15190 15191 15194 15197 15210 15211 15212 15214 15218 15220 15221 15230 15234 15238 15239 15240 15249 15257 15258 15260 15264 15266 15268 15269 15274 15279 15282 15288 15291 15294 15296 15297 15300 15303 15306 15311 15320 15321 15326 15328 1533 15330 1534 15341 15343 15345 15352 15353 15357 15360 15361 15367 15368 15369 15370 15378 1538 15381 15389 15393 15395 15402 15411 15413 15422 15425 1543 15432 15433 15435 15442 15464 15471 15478 15479 1548 15486 15489 15490 15494 15496 15499 1550 15501…
FDA’s list runs to 9,189 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 in XX states: Ak, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, the District of Columbia, Guam, and Puerto Rico.
The states and territories these words name
51 states and territories.
Every one of them
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- District of Columbia
- Delaware
- Florida
- Georgia
- Guam
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Puerto Rico
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Washington
- Wisconsin
- West Virginia
- Wyoming
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
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 Sep 28, 2017.
- FDA classified it on Feb 23, 2018.
- FDA’s Enforcement Report published it on Mar 7, 2018.
- FDA terminated it on Mar 9, 2020.
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: E-Mail.
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 9,189 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.