O-arm¿ O2 interventional fluoroscopic x-ray system
Medical device recall Z-0927-2018. Published in FDA’s Enforcement Report on Mar 14, 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 14, 2018. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 39 states named
- 449 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?
During servicing of certain internal components of the O-Arm O2 Surgical Imaging System, it is possible that the high-power cable connector may come in contact with surrounding metal during the disconnecting/reconnecting process which may result in an electrical short and a shock to the field service technician.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
O-arm¿ O2 interventional fluoroscopic x-ray system; Catalog Number: B1-700-02000 The O-arm O2 Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging for adult and pediatric patients weighting 60 lbs or greater and having an abdominal thickness of greater than 16cm, and is intended to be used where a physician benefits from 2D and 3D information of anatomic structures and objects with high x-ray attenuation such as bony anatomy and metallic objects. The O-arm O2 Imaging System is compatible with certain image guided surgery systems.
449, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Numbers: 1065R C0875 C0876 C0877 C0878 C0879 C0930 C0931 C0932 C0933 C0934 C0935 C0936 C0962 C0963 C0964 C0965 C0966 C0967 C0973 C0974 C0977 C0978 C0981 C0982 C0985 C0986R C0989 C0990 C0993 C0994R C0997 C0998 C1001 C1002 C1007 C1010…
Every code shown here, 1,995 characters
Serial Numbers: 1065R C0875 C0876 C0877 C0878 C0879 C0930 C0931 C0932 C0933 C0934 C0935 C0936 C0962 C0963 C0964 C0965 C0966 C0967 C0973 C0974 C0977 C0978 C0981 C0982 C0985 C0986R C0989 C0990 C0993 C0994R C0997 C0998 C1001 C1002 C1007 C1010 C1011 C1013 C1015 C1016 C1021 C1022 C1025 C1027 C1029 C1031 C1033 C1035 C1036 C1037 C1038 C1040 C1042 C1043 C1044 C1045 C1046 C1047 C1050 C1051 C1052 C1053 C1054 C1056 C1057 C1059 C1060 C1061 C1062 C1063 C1066 C1067 C1068 C1069 C1070 C1071 C1073 C1074 C1075 C1076 C1077 C1079 C1080 C1081 C1083 C1084 C1085 C1086 C1087 C1089 C1090 C1091 C1092 C1094 C1096 C1097 C1098 C1099 C1101 C1103 C1104 C1107 C1108 C1109 C1110 C1113 C1116 C1117 C1121R C1123 C1124 C1125 C1127 C1128 C1129 C1131 C1132 C1133 C1134 C1135 C1139 C1140 C1141 C1142 C1143 C1144 C1145 C1146 C1147 C1148 C1149 C1151 C1152 C1153 C1154 C1156 C1157 C1158 C1160 C1161 C1162 C1163 C1165 C1166 C1167 C1168 C1169 C1170 C1171 C1172 C1173 C1174 C1175 C1176 C1177 C1178 C1179 C1180 C1181 C1182 C1185 C1186 C1187 C1188 C1189 C1191 C1192 C1193 C1194 C1195 C1197 C1198 C1199 C1200 C1201 C1203 C1204 C1205 C1206 C1208R C1209 C1210 C1211 C1212 C1214 C1216 C1217 C1218 C1219 C1220 C1221 C1222 C1223 C1224 C1225 C1227 C1228 C1229 C1230 C1231 C1232 C1233 C1235 C1236 C1237 C1238 C1240 C1241 C1242 C1243R C1244 C1245 C1246 C1247 C1249 C1251 C1252 C1253 C1254 C1255 C1256 C1258 C1260 C1261 C1262 C1263 C1264 C1265 C1266 C1267 C1268 C1269 C1270 C1271 C1274 C1275 C1276 C1277 C1278 C1279 C1280 C1281 C1282 C1283 C1284 C1285 C1286 C1288 C1289 C1290 C1291 C1292 C1293 C1294 C1295 C1296 C1297 C1298 C1299 C1300 C1301 C1302 C1303 C1304 C1305 C1306 C1307 C1308 C1309 C1311 C1313 C1314 C1315 C1316 C1317 C1318 C1319 C1320 C1321 C1322 C1323 C1324 C1325 C1326 C1327 C1328 C1329 C1330 C1331 C1332 C1334 C1335 C1336 C1337 C1338 C1339 C1340 C1341 C1342 C1343 C1344 C1345 C1346 C1347 C1348 C1349 C1350 C1351 C1352 C1353 C1354 C1355 C1356 C1357 C1358 C1359 C1360 C1361 C1362 C1363 C1364 C1365 C1366 C1367 C1368 C1369 C1370 C1371…
FDA’s list runs to 3,098 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 - USA (nationwide) Distribution including Puerto Rico and to the states of : AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, MT, NC, ND, NE, NJ, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WV., and to the countries of : Australia, Austria, Bangladesh, Belgium, Brazil, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Finland, France, Germany, Iceland, India, Ireland, Israel, Italy, Japan, Jordan, Korea, Luxembourg, Martinique, Mexico, Netherlands, New Zealand, Poland, Portugal, Qatar, Romania, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, and United Kingdom.
The states and territories these words name
39 states and territories.
Every one of them
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Florida
- Georgia
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Louisiana
- Massachusetts
- Maryland
- Michigan
- Minnesota
- Missouri
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Jersey
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Puerto Rico
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Washington
- Wisconsin
- West Virginia
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?
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 30, 2017.
- FDA classified it on Mar 8, 2018.
- FDA’s Enforcement Report published it on Mar 14, 2018.
- FDA terminated it on May 2, 2019.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Medtronic Navigation, Inc.-Littleton, of Littleton, MA.
- 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 3,098 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.