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U.S. Department of Health and Human Services

Class 2 Device Recall

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 Class 2 Device Recallsee related information
Date Initiated by FirmMarch 21, 2025
Date PostedJune 09, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1819-2025
Recall Event ID 96902
510(K)NumberK170752 K171565 K172550 K192819 
Product Classification Image-intensified fluoroscopic x-ray system, mobile - Product Code OXO
ProductOEC Elite: The OEC Elite mobile C-arm is intended to provide fluoroscopic and digital spot images of the patient anatomy, interventional tools/devices, and contrast agents during diagnostic, interventional, and surgical procedures.
Code Information Two populations are potentially affected by this notification. 1. Listed in Appendix A - OEC Elite Mobile C-arm Systems (GTIN: 00001234567895) and OEC 3D Mobile C-arm Systems (GTIN: 00195278096944) that potentially have an X-ray field size greater than the 4% SID limit and do not contain the acceptance limit for the X-ray field size measurement in the System Service Manual. 2. Systems NOT listed in Appendix A - OEC Elite Mobile C-arm Systems (GTIN: 00001234567895) and OEC 3D Mobile C-arm Systems (GTIN: 00195278096944) that are within the allowed SID limit. However, the acceptance limit for the X-ray field size measurement is not stated in the System Service Manual. Appendix A Serial Numbers FAHXTX00002 FAHXTX00005 FAHXTX00014 FAHXTX00018 FAHXTX00019 FAHXTX00020 FAHXTX00024 FAHXTX00028 FAHXTX00034 FAHXTX00037 FAHXTX00043 FAHXTX00052 FAHXTX00063 FAHXTX00066 FAHXTX00068 FAHXTX00070 FAHXTX00075 FAHXTX00078 FAHXTX00079 FAHXTX00080 FAHXTX00081 FAHXTX00083 FAHXTX00092 FAHXTX00093 FAHXTX00097 FAHXTX00110 FAHXTX00111 FAHXTX00112 FAHXTX00114 FAHXTX00115 FAHXTX00116 FAHXTX00117 FAHXTX00118 FAHXTX00119 FAHXTX00120 FAHXTX00121 FAHXTX00122 FAHXTX00124 FAHXTX00125 FAHXTX00135 FAHXTX00137 FAHXTX00138 FAHXTX00151 FAHXTX00152 FAHXTX00155 FAHXTX00156 FAHXTX00162 FAHXTX00163 FAHXTX00166 FAHXTX00170 FAHXTX00171 FAHXTX00177 FAHXTX00178 FAHXTX00188 FAHXTX00192 FAHXTX00193 FAHXTX00202 FAHXTX00204 FAHXTX00211 FAHXTX00212 FAHXTX00217 FAHXTX00219 FAHXTX00220 FAHXTX00221 FAHXTX00222 FAHXTX00223 FAHXTX00224 FAHXTX00226 FAHXTX00227 FAHXTX00229 FAHXTX00230 FAHXTX00236 FAHXTX00240 FAHXTX00244 FAHXTX00261 FAHXTX00265 FAHXTX00266 FAHXTX00269 FAHXTX00271 FAHXTX00272 FAHXTX00273 FAHXTX00274 FAHXTX00280 FAHXTX00283 FAHXTX00284 FAHXTX00296 FAHXTX00299 FAHXTX00300 FAHXTX00304 FAHXTX00305 FAHXTX00308 FAHXTX00312 FAHXTX00313 FAHXTX00320 FAHXTX00323 FAHXTX00325 FAHXTX00332 FAHXTX00340 FAHXTX00342 FAHXTX00343 FAHXTX00352 FAHXTX00353 FAHXTX00354 FAHXTX00357 FAHXTX00358 FAHXTX00359 FAHXTX00360 FAHXTX00363 FAHXTX00376 FAHXTX00379 FAHXTX00381 FAHXTX00382 FAHXTX00390 FAHXTX00392 FAHXTX00399 FAHXTX00400 FAHXTX00410 FAHXTX00413 FAHXTX00414 FAHXTX00415 FAHXTX00420 FAHXTX00421 FAHXTX00429 FAHXTX00439 FAHXTX00453 FAHXTX00455 FAHXTX00456 FAHXTX00463 FAHXTX00465 FAHXTX00466 FAHXTX00479 FAHXTX00481 FAHXTX00483 FAHXTX00484 FAHXTX00486 FAHXTX00488 FAHXTX00495 FAHXTX00497 FAHXTX00498 FAHXTX00507 FAHXTX00509 FAHXTX00513 FAHXTX00523 FAHXTX00530 FAHXTX00534 FAHXTX00538 FAHXTX00539 FAHXTX00540 FAHXTX00547 FAHXTX00549 FAHXTX00555 FAHXTX00557 FAHXTX00560 FAHXTX00565 FAHXTX00569 FAHXTX00570 FAHXTX00571 FAHXTX00572 FAHXTX00575 FAHXTX00576 FAHXTX00579 FAHXTX00592 FAHXTX00595 FAHXTX00610 FAHXTX00611 FAHXXX00029 FAHXXX00030 FAHXXX00038 FAHXXX00040 FAHXXX00056 FAHXXX00057 FAHXXX00059 FAHXXX00060 FAHXXX00061 FAHXXX00069 FAHXXX00082 FAHXXX00085 FAHXXX00086 FAHXXX00089 FAHXXX00091 FAHXXX00093 FAHXXX00097 FAHXXX00098 FAHXXX00099 FAHXXX00105 FAHXXX00106 FAHXXX00112 FAHXXX00113 FAHXXX00114 FAHXXX00116 FAHXXX00117 FAHXXX00119 FAHXXX00123 FAHXXX00142 FAHXXX00144 FAHXXX00145 FAHXXX00147 FAHXXX00150 FAHXXX00151 FAHXXX00153 FAHXXX00155 FAHXXX00164 FAHXXX00173 FAHXXX00176 FAHXXX00178 FAHXXX00179 FAHXXX00188 FAHXXX00190 FAHXXX00193 FAHXXX00196 FAHXXX00199 FAHXXX00200 FAHXXX00207 FAHXXX00208 FAHXXX00209 FAMHTX00001 FAMHTX00005 FAMHTX00007 FAMHTX00012 FAMHTX00014 FAMHTX00041 FAMHTX00051 FAMHTX00055 FAMHTX00064 FAMHTX00069 FAMHTX00081 FAMHTX00085 FAMHXX00003 FAMHXX00011 FAMHXX00019 FAMHXX00023 FAXXTE00003 FAXXTE00006 FAXXTE00009 FAXXTE00011 FAXXTE00013 FAXXTE00014 FAXXTE00015 FAXXTE00017 FAXXTE00021 FAXXTE00022 FAXXTE00024 FAXXTE00025 FAXXTE00028 FAXXTE00031 FAXXTE00032 FAXXTE00033 FAXXTE00034 FAXXTE00035 FAXXTE00037 FAXXTE00038 FAXXTE00039 FAXXTE00040 FAXXTE00044 FAXXTE00046 FAXXTE00047 FAXXTE00049 FAXXTE00050 FAXXTE00051 FAXXTE00052 FAXXTE00056 FAXXTE00062 FAXXTE00063 FAXXTE00064 FAXXTE00067 FAXXTE00071 FAXXTE00072 FAXXTE00073 FAXXTE00076 FAXXTE00084 FAXXTE00085 FAXXTE00091 FAXXTE00092 FAXXTE00094 FAXXTE00095 FAXXTE00099 FAXXTE00100 FAXXTE00101 FAXXTE00104 FAXXTE00105 FAXXTE00106 FAXXTE00107 FAXXTE00109 FAXXTE00110 FAXXTE00114 FAXXTE00116 FAXXTE00117 FAXXTE00120 FAXXTE00121 FAXXTE00128 FAXXTE00129 FAXXTE00134 FAXXTE00136 FAXXTE00137 FAXXTE00141 FAXXTE00144 FAXXTE00145 FAXXTE00147 FAXXTE00149 FAXXTE00163 FAXXTE00164 FAXXTE00170 FAXXTE00173 FAXXTE00175 FAXXTE00179 FAXXTE00180 FAXXTE00182 FAXXTE00184 FAXXTE00185 FAXXTE00195 FAXXTE00197 FAXXTE00205 FAXXTE00212 FAXXTE00220 FAXXTE00224 FAXXTE00225 FAXXTE00227 FAXXTE00228 FAXXTE00229 FAXXTE00230 FAXXTE00231 FAXXTE00234 FAXXTE00236 FAXXTE00237 FAXXTE00238 FAXXTE00240 FAXXTE00241 FAXXTE00243 FAXXTE00246 FAXXTE00248 FAXXTE00253 FAXXTE00256 FAXXTE00257 FAXXTE00258 FAXXTE00259 FAXXTE00263 FAXXTE00267 FAXXTE00269 FAXXTE00270 FAXXTE00271 FAXXTE00272 FAXXTE00277 FAXXTE00278 FAXXTE00279 FAXXTE00280 FAXXTE00282 FAXXTE00286 FAXXTE00291 FAXXTE00293 FAXXTE00295 FAXXTE00301 FAXXTE00317 FAXXTE00319 FAXXTE00320 FAXXTE00321 FAXXTE00323 FAXXTE00328 FAXXTE00329 FAXXTE00330 FAXXTE00331 FAXXTE00334 FAXXTE00336 FAXXTE00337 FAXXTE00338 FAXXTE00339 FAXXTE00340 FAXXTE00342 FAXXTE00344 FAXXTE00352 FAXXTE00353 FAXXTE00354 FAXXTE00357 FAXXTE00358 FAXXTE00361 FAXXTE00362 FAXXTE00363 FAXXTE00372 FAXXTE00373 FAXXTE00376 FAXXTE00379 FAXXTE00380 FAXXTE00383 FAXXTE00389 FAXXTE00392 FAXXTE00393 FAXXTE00396 FAXXTE00407 FAXXTE00413 FAXXTE00418 FAXXTE00422 FAXXTE00424 FAXXTE00425 FAXXTE00429 FAXXTE00431 FAXXTE00433 FAXXTE00434 FAXXTE00436 FAXXTE00439 FAXXTE00442 FAXXTE00443 FAXXTE00451 FAXXTE00452 FAXXTE00454 FAXXTE00455 FAXXTE00460 FAXXTE00461 FAXXTE00472 FAXXTE00475 FAXXTE00477 FAXXTE00481 FAXXTE00482 FAXXTE00485 FAXXTE00486 FAXXTE00487 FAXXTE00489 FAXXTE00490 FAXXTE00491 FAXXTE00492 FAXXTE00495 FAXXTE00499 FAXXTE00506 FAXXTE00508 FAXXTE00511 FAXXTE00515 FAXXTE00516 FAXXTE00517 FAXXTE00518 FAXXTE00519 FAXXTE00522 FAXXTE00523 FAXXTE00525 FAXXTE00526 FAXXTE00527 FAXXTE00532 FAXXTE00533 FAXXTE00536 FAXXTE00539 FAXXTE00540 FAXXTE00543 FAXXTE00544 FAXXTE00545 FAXXTE00546 FAXXTE00547 FAXXTE00549 FAXXTE00550 FAXXTE00551 FAXXTE00553 FAXXTE00555 FAXXTE00560 FAXXTE00561 FAXXTE00562 FAXXTE00566 FAXXTE00570 FAXXTE00571 FAXXTE00572 FAXXTE00573 FAXXTE00582 FAXXTE00591 FAXXTE00593 FAXXTE00594 FAXXTE00596 FAXXTE00604 FAXXTE00607 FAXXTE00608 FAXXTE00611 FAXXTE00615 FAXXTE00616 FAXXTE00617 FAXXTE00618 FAXXTE00624 FAXXTE00631 FAXXTE00638 FAXXTE00639 FAXXTE00643 FAXXTE00646 FAXXTE00650 FAXXTE00651 FAXXTE00652 FAXXTE00653 FAXXTE00657 FAXXTE00661 FAXXTE00664 FAXXTE00667 FAXXTE00669 FAXXTE00672 FAXXTE00680 FAXXTE00681 FAXXTE00684 FAXXTE00685 FAXXTE00687 FAXXTE00688 FAXXTE00701 FAXXTE00706 FAXXTE00707 FAXXTE00710 FAXXTE00712 FAXXTE00713 FAXXTE00716 FAXXTE00718 FAXXTE00720 FAXXTE00724 FAXXTE00725 FAXXTE00728 FAXXTE00731 FAXXTE00734 FAXXTE00735 FAXXTE00737 FAXXTE00738 FAXXTE00747 FAXXTE00748 FAXXTE00749 FAXXTE00752 FAXXTE00753 FAXXTE00762 FAXXTE00766 FAXXTE00772 FAXXTE00789 FAXXTE00794 FAXXTE00799 FAXXTE00801 FAXXTE00805 FAXXTE00809 FAXXTE00810 FAXXTE00811 FAXXTE00814 FAXXTE00819 FAXXTE00820 FAXXTE00829 FAXXTE00831 FAXXTE00843 FAXXTE00853 FAXXTE00854 FAXXTE00874 FAXXTE00881 FAXXTE00893 FAXXTE00894 FAXXTE00896 FAXXTE00897 FAXXTE00899 FAXXTE00902 FAXXTE00903 FAXXTE00906 FAXXTE00909 FAXXTE00914 FAXXTE00915 FAXXTE00916 FAXXTE00917 FAXXTE00918 FAXXTE00919 FAXXTE00922 FAXXTE00925 FAXXTE00930 FAXXTE00932 FAXXTE00936 FAXXTE00939 FAXXTE00940 FAXXTE00945 FAXXTE00958 FAXXTE00961 FAXXTE00964 FAXXTE00970 FAXXTE00973 FAXXTE00979 FAXXTE00980 FAXXTE00983 FAXXTE00985 FAXXTE00987 FAXXTE00990 FAXXTE00993 FAXXTE00995 FAXXTE00996 FAXXTE00999 FAXXTE01006 FAXXTE01029 FAXXTE01030 FAXXTE01048 FAXXTE01053 FAXXTE01057 FAXXTE01064 FAXXTE01068 FAXXTE01084 FAXXTE01085 FAXXTE01086 FAXXTE01088 FAXXTE01089 FAXXTE01092 FAXXTE01114 FAXXTE01124 FAXXTE01139 FAXXTE01140 FAXXTE01141 FAXXTE01145 FAXXTE01154 FAXXTE01156 FAXXTE01159 FAXXTE01163 FAXXTE01166 FAXXTE01167 FAXXTE01168 FAXXTE01169 FAXXTE01171 FAXXTE01180 FAXXTE01183 FAXXTE01191 FAXXTE01193 FAXXTE01194 FAXXTE01195 FAXXTE01204 FAXXTE01205 FAXXTE01206 FAXXTE01210 FAXXTE01212 FAXXTE01219 FAXXTE01222 FAXXTP00003 FAXXTP00004 FAXXTP00007 FAXXTP00009 FAXXTP00010 FAXXTP00011 FAXXTP00012 FAXXTP00014 FAXXTP00018 FAXXTP00019 FAXXTP00020 FAXXXE00003 FAXXXE00004 FAXXXE00005 FAXXXE00007 FAXXXE00011 FAXXXE00012 FAXXXE00013 FAXXXE00017 FAXXXE00020 FAXXXE00021 FAXXXE00023 FAXXXE00024 FAXXXE00025 FAXXXE00026 FAXXXE00030 FAXXXE00032 FAXXXE00033 FAXXXE00036 FAXXXE00037 FAXXXE00038 FAXXXE00039 FAXXXE00043 FAXXXE00044 FAXXXE00045 FAXXXE00046 FAXXXE00047 FAXXXE00049 FAXXXE00053 FAXXXE00054 FAXXXE00056 FAXXXE00062 FAXXXE00071 FAXXXE00072 FAXXXE00076 FAXXXE00081 FAXXXE00082 FAXXXE00083 FAXXXE00085 FAXXXE00087 FAXXXE00091 FAXXXE00092 FAXXXE00093 FAXXXE00095 FAXXXE00096 FAXXXE00097 FAXXXE00098 FAXXXE00100 FAXXXE00105 FAXXXE00107 FAXXXE00109 FAXXXE00117 FAXXXE00120 FAXXXE00121 FAXXXE00124 FAXXXE00141 FAXXXE00147 FAXXXE00152 FAXXXE00155 FAXXXE00159 FAXXXE00164 FAXXXE00165 FAXXXE00167 FAXXXE00172 FAXXXE00174 FAXXXE00176 FAXXXE00180 FAXXXE00181 FAXXXE00183 FAXXXE00184 FAXXXE00185 FAXXXE00188 FAXXXE00196 FAXXXE00197 FAXXXE00198 FAXXXE00199 FAXXXE00200 FAXXXE00204 FAXXXE00206 FAXXXE00208 FAXXXE00210 FAXXXE00215 FAXXXE00217 FAXXXE00218 FAXXXE00222 FAXXXE00225 FAXXXE00227 FAXXXE00228 FAXXXE00229 FAXXXE00230 FAXXXE00231 FAXXXE00232 FAXXXE00235 FAXXXE00236 FAXXXE00238 FAXXXE00240 FAXXXE00244 FAXXXE00247 FAXXXE00251 FAXXXE00253 FAXXXE00254 FAXXXE00255 FAXXXE00256 FAXXXE00257 FAXXXE00261 FAXXXE00269 FAXXXE00270 FAXXXE00273 FAXXXE00275 FAXXXE00278 FAXXXE00279 FAXXXE00280 FAXXXE00282 FAXXXE00283 FAXXXE00287 FAXXXE00288 FAXXXE00290 FAXXXE00291 FAXXXE00292 FAXXXE00296 FAXXXE00297 FAXXXE00302 FAXXXE00303 FAXXXE00306 FAXXXE00312 FAXXXE00314 FAXXXE00315 FAXXXE00318 FAXXXE00319 FAXXXE00320 FAXXXE00321 FAXXXE00324 FAXXXE00325 FAXXXE00327 FAXXXE00328 FAXXXE00329 FAXXXE00330 FAXXXE00332 FAXXXE00335 FAXXXE00336 FAXXXE00339 FAXXXE00340 FAXXXE00343 FAXXXE00345 FAXXXE00346 FAXXXE00348 FAXXXE00354 FAXXXE00356 FAXXXE00359 FAXXXX00014 FAXXXX00020 FBHVXX00037 FBHVXX00040 FBHXTX00002 FBHXTX00006 FBHXTX00007 FBHXTX00009 FBHXTX00010 FBHXTX00011 FBHXTX00013 FBHXTX00019 FBHXTX00020 FBHXTX00021 FBHXTX00022 FBHXTX00023 FBHXTX00024 FBHXTX00025 FBHXTX00026 FBHXTX00031 FBHXTX00032 FBHXTX00033 FBHXTX00035 FBHXTX00038 FBHXTX00045 FBHXTX00047 FBHXTX00048 FBHXTX00051 FBHXTX00057 FBHXTX00059 FBHXTX00062 FBHXTX00068 FBHXTX00070 FBHXTX00071 FBHXTX00074 FBHXTX00079 FBHXTX00080 FBHXTX00081 FBHXTX00095 FBHXTX00098 FBHXTX00102 FBHXTX00103 FBHXTX00104 FBHXTX00106 FBHXTX00114 FBHXTX00115 FBHXTX00125 FBHXTX00126 FBHXTX00128 FBHXTX00130 FBHXTX00137 FBHXTX00144 FBHXTX00149 FBHXTX00151 FBHXTX00154 FBHXTX00159 FBHXTX00161 FBHXTX00163 FBHXTX00172 FBHXTX00173 FBHXTX00177 FBHXTX00184 FBHXTX00198 FBHXTX00199 FBHXTX00201 FBHXTX00203 FBHXTX00204 FBHXTX00205 FBHXTX00208 FBHXTX00210 FBHXTX00218 FBHXTX00223 FBHXTX00231 FBHXTX00233 FBHXTX00234 FBHXTX00235 FBHXTX00237 FBHXTX00241 FBHXTX00261 FBHXTX00266 FBHXTX00274 FBHXTX00275 FBHXTX00276 FBHXTX00277 FBHXTX00278 FBHXTX00279 FBHXTX00281 FBHXTX00282 FBHXTX00287 FBHXTX00290 FBHXTX00295 FBHXTX00316 FBHXTX00317 FBHXTX00319 FBHXTX00320 FBHXTX00324 FBHXTX00330 FBHXTX00335 FBHXTX00336 FBHXTX00337 FBHXTX00338 FBHXTX00339 FBHXTX00343 FBHXTX00344 FBHXTX00345 FBHXTX00348 FBHXTX00349 FBHXTX00350 FBHXTX00351 FBHXTX00352 FBHXTX00353 FBHXTX00354 FBHXTX00355 FBHXTX00356 FBHXTX00357 FBHXTX00360 FBHXTX00361 FBHXTX00362 FBHXTX00365 FBHXTX00366 FBHXTX00368 FBHXTX00369 FBHXTX00371 FBHXTX00375 FBHXTX00379 FBHXTX00381 FBHXTX00411 FBHXTX00415 FBHXTX00416 FBHXTX00417 FBHXTX00429 FBHXTX00431 FBHXTX00432 FBHXTX00433 FBHXTX00436 FBHXTX00438 FBHXTX00442 FBHXTX00444 FBHXTX00447 FBHXTX00448 FBHXTX00451 FBHXTX00458 FBHXTX00462 FBHXTX00468 FBHXTX00479 FBHXTX00482 FBHXTX00490 FBHXTX00491 FBHXTX00493 FBHXTX00498 FBHXTX00499 FBHXTX00500 FBHXTX00501 FBHXTX00503 FBHXTX00504 FBHXTX00505 FBHXTX00507 FBHXTX00508 FBHXTX00509 FBHXTX00510 FBHXTX00514 FBHXTX00516 FBHXTX00520 FBHXTX00524 FBHXTX00529 FBHXTX00535 FBHXTX00537 FBHXTX00541 FBHXTX00543 FBHXTX00546 FBHXTX00549 FBHXTX00551 FBHXTX00555 FBHXTX00558 FBHXTX00561 FBHXTX00565 FBHXTX00568 FBHXTX00570 FBHXTX00571 FBHXTX00580 FBHXTX00583 FBHXTX00584 FBHXTX00586 FBHXTX00587 FBHXTX00589 FBHXTX00593 FBHXTX00597 FBHXTX00599 FBHXTX00600 FBHXTX00601 FBHXTX00605 FBHXTX00606 FBHXTX00613 FBHXTX00614 FBHXTX00616 FBHXTX00617 FBHXTX00624 FBHXTX00630 FBHXTX00641 FBHXTX00642 FBHXTX00644 FBHXTX00649 FBHXTX00650 FBHXTX00651 FBHXTX00655 FBHXTX00664 FBHXTX00665 FBHXTX00667 FBHXTX00669 FBHXTX00671 FBHXTX00672 FBHXTX00673 FBHXTX00679 FBHXTX00680 FBHXTX00682 FBHXTX00684 FBHXTX00686 FBHXTX00687 FBHXTX00689 FBHXTX00690 FBHXTX00691 FBHXTX00693 FBHXTX00698 FBHXTX00700 FBHXTX00703 FBHXTX00713 FBHXTX00719 FBHXTX00721 FBHXTX00727 FBHXTX00737 FBHXTX00745 FBHXTX00748 FBHXTX00753 FBHXTX00755 FBHXTX00757 FBHXTX00758 FBHXTX00760 FBHXTX00762 FBHXTX00764 FBHXTX00769 FBHXTX00770 FBHXTX00771 FBHXTX00774 FBHXTX00783 FBHXTX00785 FBHXTX00798 FBHXTX00800 FBHXTX00803 FBHXTX00804 FBHXTX00821 FBHXTX00823 FBHXTX00826 FBHXTX00834 FBHXTX00837 FBHXTX00839 FBHXTX00841 FBHXTX00843 FBHXTX00844 FBHXTX00847 FBHXTX00848 FBHXTX00849 FBHXTX00866 FBHXTX00867 FBHXTX00894 FBHXTX00896 FBHXTX00897 FBHXTX00898 FBHXTX00899 FBHXTX00901 FBHXTX00909 FBHXTX00912 FBHXTX00913 FBHXTX00914 FBHXTX00916 FBHXTX00920 FBHXTX00921 FBHXTX00922 FBHXTX00924 FBHXTX00925 FBHXTX00926 FBHXTX00930 FBHXTX00933 FBHXTX00934 FBHXTX00936 FBHXTX00937 FBHXTX00938 FBHXTX00942 FBHXTX00943 FBHXTX00946 FBHXTX00952 FBHXTX00954 FBHXTX00955 FBHXTX00964 FBHXTX00971 FBHXTX00972 FBHXTX00974 FBHXTX00977 FBHXTX00980 FBHXTX00982 FBHXTX00986 FBHXTX00991 FBHXTX00995 FBHXTX00996 FBHXTX01002 FBHXTX01006 FBHXTX01013 FBHXTX01014 FBHXTX01016 FBHXTX01031 FBHXTX01040 FBHXTX01045 FBHXTX01048 FBHXTX01049 FBHXTX01050 FBHXTX01062 FBHXTX01063 FBHXTX01070 FBHXTX01074 FBHXTX01075 FBHXTX01076 FBHXTX01077 FBHXTX01078 FBHXTX01079 FBHXTX01080 FBHXTX01100 FBHXTX01101 FBHXTX01102 FBHXTX01104 FBHXTX01108 FBHXTX01109 FBHXTX01110 FBHXTX01111 FBHXTX01119 FBHXTX01123 FBHXTX01126 FBHXTX01127 FBHXTX01130 FBHXTX01131 FBHXTX01132 FBHXTX01135 FBHXTX01138 FBHXTX01139 FBHXTX01140 FBHXTX01145 FBHXTX01147 FBHXTX01150 FBHXTX01153 FBHXTX01154 FBHXTX01156 FBHXTX01157 FBHXTX01158 FBHXTX01165 FBHXTX01170 FBHXTX01176 FBHXTX01180 FBHXTX01184 FBHXTX01189 FBHXTX01193 FBHXTX01194 FBHXTX01200 FBHXTX01201 FBHXTX01202 FBHXTX01217 FBHXTX01222 FBHXTX01223 FBHXTX01228 FBHXTX01229 FBHXTX01230 FBHXTX01231 FBHXTX01232 FBHXTX01233 FBHXTX01234 FBHXTX01239 FBHXTX01240 FBHXTX01241 FBHXTX01244 FBHXTX01246 FBHXTX01251 FBHXTX01252 FBHXTX01264 FBHXTX01265 FBHXTX01267 FBHXTX01268 FBHXTX01269 FBHXTX01270 FBHXTX01271 FBHXTX01273 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Recalling Firm/
Manufacturer		 GE Medical Systems, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information Contact
262-544-3011
Manufacturer Reason
for Recall		OEC Elite and OEC 3D Mobile C-Arms Exceeding 4% Source to Image Distance in X-ray Field.
FDA Determined
Cause 2		Process control
ActionAll impacted customers with receive a customer letter notifying them of the potential issue. GE HealthCare will send a field service engineer to perform measurements of the Xray field on the identified systems (listed in Appendix A of the customer letter).
Quantity in CommerceTotal for both products: 3472 (2,919 US; 553 OUS)
DistributionUS and OUS
Total Product Life CycleTPLC 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = OXO
510(K)s with Product Code = OXO
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