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U.S. Department of Health and Human Services

Class 2 Device Recall OrthoScan FD Mini CArm

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  Class 2 Device Recall OrthoScan FD Mini CArm see related information
Date Initiated by Firm August 31, 2017
Create Date January 09, 2018
Recall Status1 Terminated 3 on April 21, 2021
Recall Number Z-0261-2018
Recall Event ID 78784
510(K)Number K133174  
Product Classification Image-intensified fluoroscopic x-ray system, mobile - Product Code OXO
Product Mobile Mini C-arm system Part # 1000-0004-FD.

Intended to provide the physician with general fluoroscopic visualization of the patient, including, but not limited to, surgical orthopedic procedures and critical and emergency care procedures.
Code Information Serial Number List:  5E1290 5H0178 5H0125 5E833 5E1164 5F0395 5E730 5E105 5H0126 5E921 5E742 5F0400 5E756 5E0940 5H0130 5F0126 5F0282 5F0412 5E763 5E0943 5H0151 5F0229 5H0273 5F0441 5E841 5E0961 5H0172 5F0230 5E0944 5F0449 5F0232 5E0981 5H0190 5F0387 5E0945 5F0451 5H0291 5E0982 5H0333 5F0445 5E0955 5F0456 5F0177 5E1009 5E0954 5F0453 5E1000 5F0468 5F0242 5E1042 5E1043 5F0457 5E1025 5F0471 5F0295 5E1051 5E1234 5F0465 5E1177 5F0482 5H0265 5E1063 5E1280 5F0610 5E1185 5F0495 5H0292 5E1080 5E908 5H0104 5E1225 5F0497 5E0938 5E1141 5F0158 5H0114 5E1249 5F0517 5E0990 5E1151 5F0408 5E1174 5E1265 5F0533 5E1021 5E1224 5F0519 5E1232 5E1276 5F0537 5E1032 5E1233 5H0272 5E846 5E1279 5F0548 5E1086 5E1266 5H0290 5E1137 5E1288 5F0594 5E1087 5E1269 5E0998 5E1257 5E734 5F0603 5E1105 5E1284 5E1033 5E1176 5E744 5F0621 5E1115 5E1293 5E1035 5E1178 5E772 5F0626 5E1150 5E1315 5E1047 5E1197 5E775 5F0630 5E1261 5E1316 5E1082 5E1303 5E818 5F0631 5E1287 5E739 5E1242 5E769 5E822 5F0632 5E1292 5E743 5E1289 5E794 5E843 5H0109 5E1299 5E761 5E1305 5E919 5E874 5H0116 5E1317 5E765 5E748 5F0188 5E875 5H0133 5E771 5E773 5F0378 5F0206 5E877 5H0137 5E792 5E782 5F0535 5F0207 5E883 5H0138 5E797 5E806 5H0352 5F0215 5E929 5H0139 5F0255 5E823 5H0354 5F0304 5F0112 5H0162 5F0273 5E860 5H0371 5F0416 5F0113 5H0173 5F0363 5E869 5E0964 5F0494 5F0118 5H0192 5F0474 5E893 5E1112 5F0506 5F0139 5H0193 5F0600 5E922 5E1179 5F0554 5F0140 5H0201 5F0618 5F0108 5E1246 5H0189 5F0221 5H0207 5F0620 5F0153 5E1301 5H0230 5F0331 5H0212 5F0625 5F0155 5E1302 5H0259 5F0467 5H0229 5F0633 5F0165 5E731 5H0260 5F0469 5H0232 5F0634 5F0173 5E746 5H0313 5F0518 5H0234 5H0106 5F0178 5E779 5H0361 5F0553 5H0237 5H0158 5F0199 5E800 5H0362 5H0161 5H0251 5H0231 5F0200 5E820 5E0988 5H0226 5H0252 5H0358 5F0211 5E839 5E1159 5H0246 5H0295 5E0937 5F0234 5F0216 5E1297 5H0296 5H0297 5E0992 5F0263 5F0320 5E732 5H0307 5H0302 5E1048 5F0264 5F0423 5E751 5H0312 5H0303 5E1066 5F0283 5F0523 5E816 5H0366 5H0304 5E1106 5F0290 5F0590 5E851 5E1133 5H0332 5E1123 5F0329 5H0118 5E932 5E1300 5H0360 5E1165 5F0350 5H0179 5F0183 5H0322 5H0372 5E1171 5F0352 5H0357 5F0185 5H0339 5E0959 5E1209 5F0390 5H0369 5H0110 5E1204 5E0970 5E1250 5F0396 5E0995 5E1019 5E0994 5E1030 5E1278 5F0397 5E1037 5E1023 5E1010 5E1187 5E1286 5F0398 5E1071 5E1318 5E1015 5E1277 5E723 5F0407 5E1072 5E855 5E1198 5E729 5E733 5F0419 5E1183 5F0102 5E1212 5E754 5E752 5F0483 5E1184 5F0270 5E1308 5E768 5E815 5F0538 5E1230 5F0277 5E745 5E817 5E825 5F0544 5E832 5F0461 5E826 5E837 5E904 5F0592 5E887 5F0575 5E827 5E850 5E905 5F0599 5E889 5H0274 5E842 5E871 5E907 5H0107 5F0151 5E0950 5E873 5F0104 5E918 5H0141 5F0156 5E0951 5E933 5F0136 5F0107 5H0174 5F0157 5E0996 5F0141 5F0142 5F0114 5H0197 5F0162 5E1003 5F0202 5F0144 5F0122 5H0200 5F0299 5E1006 5F0203 5F0187 5F0130 5H0204 5F0300 5E1007 5F0307 5F0212 5F0135 5H0216 5F0406 5E1022 5F0308 5F0265 5F0152 5H0289 5F0410 5E1140 5F0309 5H0266 5F0168 5H0305 5F0413 5E1145 5F0340 5H0315 5F0298 5E0947 5F0421 5E1202 5F0359 5E0952 5F0323 5E1029 5F0536 5E1208 5F0422 5E0972 5F0332 5E1052 5F0551 5E1217 5F0448 5E1034 5F0369 5E1070 5F0593 5E1222 5F0460 5E1040 5F0377 5E847 5F0598 5E1235 5F0567 5E1090 5F0402 5E917 5H0261 5E1236 5F0615 5E1098 5F0414 5F0243 5H0267 5E1238 5F0629 5E1119 5F0424 5F0245 5H0368 5E1251 5H0215 5E1120 5F0439 5F0436 5E1081 5E1274 5H0283 5E1121 5F0447 5F0564 5E1101 5E727 5H0301 5E1122 5F0450 5H0308 5E1130 5E783 5E1311 5E1144 5F0472 5E1227 5E1138 5E795 5E1053 5E1196 
Recalling Firm/
Orthoscan, Inc.
8212 E Evans Rd
Scottsdale AZ 85260-3670
For Additional Information Contact National Customer Service
Manufacturer Reason
for Recall
OrthoScan Inc. discovered during investigation of a non-standard work flow a non-conformity of the devices. Specifically, the system software allows a user to activate the Digital Zoom feature in the course of taking a live image exposing a larger x-ray field than can be viewed by the user
FDA Determined
Cause 2
Software design
Action Orthoscan sent an Urgent Recall Notice, dated August 30, 2017, to customers, informing them of the issue and how to address it. Customers are to use the attached list of serial numbers to determine if their device is affected. Customers may continue to use their affected device with caution until the on-site correction has been made. Users should avoid non-conforming workflows by taking the measures outlined in the letter. The firm will contact customers to arrange implementation of the corrective action at no cost to the customer. If there are further questions or concerns, please call National Customer Service Team at (866) 949-4346.
Quantity in Commerce 2012 total
Distribution Worldwide Distribution - USA (nationwide) including Puerto Rico and Hawaii and to the countries of : Australia, Austria, Belgium, Canada, Dominican Republic, Estonia , Finland, France, Germany, Hanover, Hong Kong, Israel, Italy, Japan, Jonesboro, Korea, Malaysia. Netherland, New Zealand, Norway, Poland, Russia, Saudi Arabia, Spain, Sweden, Switzerland, Taiwan, UAE, and United Kingdom.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = OXO and Original Applicant = ORTHOSCAN, INC.