Artis zee and Artis zeego
Medical device recall Z-0710-2018. 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
- 510 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 zee and Artis zeego model Interventional fluoroscopic x-ray foot switch accessory; Model Numbers: 4787797, 4787805, and 4787813.
510, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Numbers: 10000 10006 10009 10010 10016 10018 10019 10027 10029 10030 10040 10042 10044 10046 10047 10048 10055 10056 10059 10062 10068 10069 10073 10075 10080 10084 10089 10094 10095 10096 10098 10099 10100 10102 10103 10104 10111…
Every code shown here, 1,998 characters
Serial Numbers: 10000 10006 10009 10010 10016 10018 10019 10027 10029 10030 10040 10042 10044 10046 10047 10048 10055 10056 10059 10062 10068 10069 10073 10075 10080 10084 10089 10094 10095 10096 10098 10099 10100 10102 10103 10104 10111 10112 10115 10116 10121 10122 10125 10126 10128 10133 1027 1049 1059 1072 1084 1085 1096 1101 1102 1104 1105 1111 1112 1115 1117 1122 1129 1131 1139 1144 1147 1149 1156 1157 1160 1165 1166 1182 1188 1189 1196 1199 1204 1205 1206 1208 1222 1227 1228 1229 1232 1233 1240 1242 1243 1245 1246 1248 1252 1255 1256 1258 1260 1262 1266 1267 1269 1270 1274 1278 1279 1282 1283 1286 1292 1293 1294 1295 1299 1300 13173 15000 15003 15004 15015 15016 15021 15024 15026 15028 15033 15034 15042 15045 15049 15053 15055 15056 15066 15069 15070 15074 15076 15079 15080 15087 15100 15103 15104 15105 15106 15108 15109 15111 15112 15114 15116 15118 15119 15121 15122 15124 15126 15127 15128 15134 15135 15138 15139 15143 15144 15153 15154 15158 15159 15160 15164 15167 15180 15190 15197 15200 15207 15224 17002 17003 17012 17017 17020 17023 17032 17035 17036 17037 17041 17056 17057 17058 17059 17072 17073 17074 17077 17078 17081 17094 17096 17099 17101 17102 17104 17105 17107 17109 17113 17130 17143 17146 17151 17155 17159 17160 17167 17174 17177 20000 20008 20009 20017 20020 20022 20029 20037 20042 20046 20051 20057 20059 20060 20062 20064 20066 20069 20070 20071 20075 20076 20077 20078 20081 20083 20087 20088 20090 20097 20098 20101 20102 20104 20106 20108 20110 20113 20114 20116 20117 20119 20121 20122 20125 20126 20128 20129 20130 20131 20132 20133 20138 20140 20146 20148 20159 20160 20161 20173 20183 20193 20195 20197 20199 20200 20209 20216 20219 20220 20226 20227 20228 20232 20236 20237 20239 20241 20243 20246 20248 20249 20253 20254 20261 20263 20264 20265 20268 20270 20274 20277 20279 20281 20282 20287 20290 20293 20294 20296 20298 20299 20301 20314 20315 20320 20321 20323 20325 20328 20329 20333 20334 20337 20339 20340 20348 20349 20358 20362 20369…
FDA’s list runs to 3,005 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 3,005 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.