OEC 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.

Detalles del retiro

Fabricante

GE Medical Systems, LLC

Distribuidor

US and OUS

Lote

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

Clasificación de riesgo

Class II

Área (FDA)

device

País

United States