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U.S. Department of Health and Human Services

Class 2 Device Recall GE DatexOhmeda Aisys Anesthesia System

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 Class 2 Recall
GE DatexOhmeda Aisys Anesthesia System
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Date Posted October 06, 2010
Recall Status1 Terminated on September 13, 2012
Recall Number Z-0008-2011
Recall Event ID 56599
Premarket Notification
510(K) Numbers
K081844  K090233 
Product Classification Gas-Machine, Anesthesia - Product Code BSZ
Product GE Datex-Ohmeda Aisys Anesthesia System, manufactured by GE Healthcare, P.O. Box 900, FIN-00031 GE, Finland
Code Information ANAH00114 ANAH00115 ANAH00116 ANAH00117 ANAH00119 ANAH00120 ANAH00121 ANAH00122 ANAH00123 ANAH00124 ANAH00125 ANAH00126 ANAJ00100 ANAJ00101 ANAJ00102 ANAJ00103 ANAJ00104 ANAJ00106 ANAJ00107 ANAJ00108 ANAJ00109 ANAJ00110 ANAJ00111 ANAJ00112 ANAJ00113 ANAJ00114 ANAJ00115 ANAJ00116 ANAJ00119 ANAJ00120 ANAJ00121 ANAJ00122 ANAJ00123 ANAJ00124 ANAJ00125 ANAJ00126 ANAJ00127 ANAJ00128 ANAJ00129 ANAJ00131 ANAJ00132 ANAJ00133 ANAJ00134 ANAJ00135 ANAJ00136 ANAJ00137 ANAJ00141 ANAJ00142 ANAJ00143 ANAJ00145 ANAJ00146 ANAJ00147 ANAJ00164 ANAJ00165 ANAJ00166 ANAJ00167 ANAJ00168 ANAJ00169 ANAJ00170 ANAJ00171 ANAJ00172 ANAJ00173 ANAJ00174 ANAJ00175 ANAJ00176 ANAJ00177 ANAJ00178 ANAJ00179 ANAJ00180 ANAJ00181 ANAJ00182 ANAJ00183 ANAJ00184 ANAJ00185 ANAJ00186 ANAJ00187 ANAJ00188 ANAJ00189 ANAJ00190 ANAJ00191 ANAJ00194 ANAJ00195 ANAJ00196 ANAJ00197 ANAJ00198 ANAJ00199 ANAJ00200 ANAJ00201 ANAJ00202 ANAJ00203 ANAJ00204 ANAJ00205 ANAJ00206 ANAJ00207 ANAJ00208 ANAJ00209 ANAJ00210 ANAJ00211 ANAJ00212 ANAJ00213 ANAJ00214 ANAJ00215 ANAJ00216 ANAJ00217 ANAJ00218 ANAJ00219 ANAJ00220 ANAJ00221 ANAJ00222 ANAJ00223 ANAJ00224 ANAJ00225 ANAJ00226 ANAJ00227 ANAJ00228 ANAJ00229 ANAJ00230 ANAJ00231 ANAJ00232 ANAJ00233 ANAJ00234 ANAJ00235 ANAJ00236 ANAJ00237 ANAJ00238 ANAJ00239 ANAJ00240 ANAJ00241 ANAJ00242 ANAJ00243 ANAJ00244 ANAJ00245 ANAJ00246 ANAJ00247 ANAJ00248 ANAJ00249 ANAJ00250 ANAJ00251 ANAJ00252 ANAJ00253 ANAJ00254 ANAJ00255 ANAJ00256 ANAJ00257 ANAJ00258 ANAJ00259 ANAJ00260 ANAJ00261 ANAJ00264 ANAJ00265 ANAJ00266 ANAJ00267 ANAK00100 ANAK00101 ANAK00102 ANAK00103 ANAK00104 ANAK00105 ANAK00106 ANAK00109 ANAK00110 ANAK00111 ANAK00112 ANAK00113 ANAK00114 ANAK00115 ANAK00116 ANAK00117 ANAK00118 ANAK00119 ANAK00120 ANAK00121 ANAK00123 ANAK00124 ANAK00125 ANAK00126 ANAK00127 ANAK00128 ANAK00129 ANAK00130 ANAK00131 ANAK00132 ANAK00133 ANAK00134 ANAK00135 ANAK00136 ANAK00137 ANAK00138 ANAK00139 ANAK00140 ANAK00142 ANAK00143 ANAK00144 ANAK00145 ANAK00156 ANAK00157 ANAK00158 ANAK00159 ANAK00160 ANAK00162 ANAK00163 ANAK00164 ANAK00165 ANAK00166 ANAK00167 ANAK00168 ANAK00169 ANAK00170 ANAK00171 ANAK00172 ANAK00173 ANAK00174 ANAK00175 ANAK00176 ANAK00177 ANAK00178 ANAK00179 ANAK00180 ANAK00181 ANAK00182 ANAK00183 ANAK00184 ANAK00185 ANAK00186 ANAK00187 ANAK00188 ANAK00189 ANAK00190 ANAK00191 ANAK00192 ANAK00193 ANAK00194 ANAK00195 ANAK00196 ANAK00197 ANAK00198 ANAK00199 ANAK00200 ANAK00201 ANAK00202 ANAK00203 ANAK00207 ANAK00213 ANAK00214 ANAK00215 ANAK00223 ANAK00224 ANAK00225 ANAK00226 ANAK00227 ANAK00228 ANAK00229 ANAK00230 ANAK00231 ANAK00232 ANAK00233 ANAK00236 ANAK00238 ANAK00239 ANAK00241 ANAK00242 ANAK00247 ANAK00248 ANAK00249 ANAK00250 ANAK00254 ANAK00255 ANAK00256 ANAK00257 ANAK00258 ANAK00259 ANAK00260 ANAK00261 ANAK00262 ANAK00263 ANAK00264 ANAK00265 ANAK00266 ANAK00268 ANAK00269 ANAK00270 ANAK00271 ANAK00272 ANAK00273 ANAK00273- ANAK00274 ANAK00275 ANAK00276 ANAK00277 ANAK00278 ANAK00279 ANAK00280 ANAK00284 ANAK00285 ANAK00286 ANAK00287 ANAK00288 ANAK00289 ANAK00290 ANAK00291 ANAK00292 ANAK00293 ANAK00294 ANAK00295 ANAK00296 ANAK00297 ANAK00298 ANAK00299 ANAK00300 ANAK00301 ANAK00302 ANAK00303 ANAK00304 ANAK00305 ANAK00306 ANAK00307 ANAK00308 ANAK00309 ANAK00310 ANAK00311 ANAK00312 ANAK00313 ANAK00314 ANAK00315 ANAK00316 ANAK00317 ANAK00318 ANAK00319 ANAK00320 ANAK00321 ANAK00322 ANAK00323 ANAK00324 ANAK00325 ANAK00326 ANAK00327 ANAK00337 ANAK00338 ANAK00339 ANAK00340 ANAK00343 ANAK00345 ANAK00346 ANAK00347 ANAK00358 ANAK00359 ANAK00360 ANAK00361 ANAK00362 ANAK00363 ANAK00364 ANAK00365 ANAK00366 ANAK00367 ANAK00368 ANAK00369 ANAK00370 ANAK00371 ANAK00372 ANAK00373 ANAK00374 ANAK00375 ANAK00376 ANAK00377 ANAK00380 ANAK00381 ANAK00382 ANAK00383 ANAK00384 ANAK00385 ANAK00387 ANAK00388 ANAK00389 ANAK00390 ANAK00391 ANAK00392 ANAK00393 ANAK00394 ANAK00395 ANAK00396 ANAK00397 ANAK00398 ANAK00399 ANAK00400 ANAK00401 ANAK00402 ANAK00403 ANAK00404 ANAK00405 ANAK00406 ANAK00407 ANAK00408 ANAK00409 ANAK00422 ANAK00425 ANAK00426 ANAK00427 ANAK00428 ANAK00429 ANAK00430 ANAK00431 ANAK00432 ANAK00433 ANAK00434 ANAK00435 ANAK00436 ANAK00437 ANAK00438 ANAK00439 ANAK00440 ANAK00456 ANAK00457 ANAK00458 ANAK00459 ANAK00461 ANAK00463 ANAK00464 ANAK00465 ANAK00471 ANAK00472 ANAK00478 ANAK00479 ANAK00480 ANAK00492 ANAK00506 ANAK00509 ANAK00510 ANAK00511 ANAK00512 ANAK00513 ANAK00514 ANAK00526 ANAK00527 ANAK00528 ANAK00529 ANAK00530 ANAK00579 ANAK00580 ANAK00581 ANAK00582 ANAK00583 ANAK00584 ANAK00585 ANAK00586 ANAK00587 ANAK00588 ANAK00589 ANAK00598 ANAK00599 ANAK00600 ANAK00601 ANAK00602 ANAK00615 ANAK00616 ANAK00617 ANAK00618 ANAK00619 ANAK00620 ANAK00621 ANAK00622 ANAK00623 ANAK00625 ANAK00626 ANAK00627 ANAK00628 ANAK00629 ANAK00630 ANAK00631 ANAK00632 ANAK00633 ANAK00634 ANAK00635 ANAK00636 ANAK00637 ANAK00638 ANAK00639 ANAK00640 ANAK00641 ANAK00643 ANAK00644 ANAK00653 ANAK00657 ANAK00658 ANAK00659 ANAK00660 ANAK00661 ANAK00662 ANAK00663 ANAK00664 ANAK00665 ANAK00681 ANAK00682 ANAK00683 ANAK00689 ANAK00702 ANAK00703 ANAK00704 ANAK00705 ANAK00706 ANAK00707 ANAK00708 ANAK00709 ANAK00710 ANAK00711 ANAK00712 ANAK00713 ANAK00714 ANAK00715 ANAK00716 ANAK00717 ANAK00720 ANAK00721 ANAK00722 ANAK00723 ANAK00724 ANAK00725 ANAK00726 ANAK00727 ANAK00728 ANAK00758 ANAK00759 ANAK00760 ANAK00761 ANAK00762 ANAK00763 ANAK00764 ANAK00765 ANAK00771 ANAK00772 ANAK00773 ANAK00774 ANAK00775 ANAK00776 ANAK00777 ANAK00778 ANAK00779 ANAK00780 ANAK00781 ANAK00782 ANAK00783 ANAK00784 ANAK00785 ANAK00786 ANAK00787 ANAK00788 ANAK00789 ANAK00790 ANAK00791 ANAK00792 ANAK00798 ANAK00799 ANAK00800 ANAK00801 ANAK00802 ANAK00803 ANAK00804 ANAK00805 ANAK00806 ANAK00807 ANAK00808 ANAK00809 ANAK00810 ANAK00811 ANAK00812 ANAK00813 ANAK00814 ANAK00815 ANAK00816 ANAK00817 ANAK00818 ANAK00819 ANAK00820 ANAK00821 ANAK00822 ANAK00823 ANAK00824 ANAK00825 ANAK00826 ANAK00827 ANAK00828 ANAK00829 ANAK00830 ANAK00831 ANAK00832 ANAK00833 ANAK00834 ANAK00835 ANAK00836 ANAK00837 ANAK00838 ANAK00839 ANAK00840 ANAK00841 ANAK00842 ANAK00843 ANAK00844 ANAK00845 ANAK00846 ANAK00847 ANAK00848 ANAK00849 ANAK00850 ANAK00851 ANAK00852 ANAK00853 ANAK00861 ANAK00863 ANAK00864 ANAK00865 ANAK00866 ANAK00867 ANAK00868 ANAK00869 ANAK00870 ANAK00871 ANAK00872 ANAK00873 ANAK00874 ANAK00875 ANAK00876 ANAK00877 ANAK00878 ANAK00879 ANAK00880 ANAK00881 ANAK00882 ANAK00883 ANAK00884 ANAK00885 ANAK00886 ANAK00887 ANAK00888 ANAK00889 ANAK00890 ANAK00891 ANAK00892 ANAK00906 ANAK00907 ANAK00908 ANAK00909 ANAK00910 ANAK00922 ANAK00923 ANAK00924 ANAK00925 ANAK00926 ANAK00927 ANAK00928 ANAK00929 ANAK00930 ANAK00931 ANAK00932 ANAK00933 ANAK00934 ANAK00935 ANAK00936 ANAK00937 ANAL00100 ANAL00101 ANAL00102 ANAL00105 ANAL00106 ANAL00107 ANAL00108 ANAL00109 ANAL00116 ANAL00121 ANAL00122 ANAL00123 ANAL00124 ANAL00125 ANAL00126 ANAL00140 ANAL00141 ANAL00142 ANAL00143 ANAL00144 ANAL00145 ANAL00146 ANAL00147 ANAL00148 ANAL00149 ANAL00150 ANAL00151 ANAL00152 ANAL00153 ANAL00154 ANAL00155 ANAL00156 ANAL00157 ANAL00158 ANAL00159 ANAL00165 ANAL00166 ANAL00167 ANAL00168 ANAL00169 ANAL00170 ANAL00171 ANAL00172 ANAL00173 ANAL00174 ANAL00175 ANAL00176 ANAL00177 ANAL00178 ANAL00179 ANAL00180 ANAL00181 ANAL00182 ANAL00183 ANAL00184 ANAL00185 ANAL00186 ANAL00187 ANAL00188 ANAL00189 ANAL00190 ANAL00191 ANAL00192 ANAL00193 ANAL00194 ANAL00195 ANAL00196 ANAL00197 ANAL00200 ANAL00201 ANAL00202 ANAL00203 ANAL00204 ANAL00205 ANAL00206 ANAL00207 ANAL00208 ANAL00209 ANAL00210 ANAL00211 ANAL00212 ANAL00213 ANAL00214 ANAL00215 ANAL00216 ANAL00217 ANAL00218 ANAL00219 ANAL00220 ANAL00221 ANAL00222 ANAL00223 ANAL00224 ANAL00225 ANAL00226 ANAL00227 ANAL00228 ANAL00244 ANAL00246 ANAL00247 ANAL00248 ANAL00250 ANAL00251 ANAL00252 ANAL00253 ANAL00254 ANAL00255 ANAL00256 ANAL00257 ANAL00258 ANAL00259 ANAL00260 ANAL00261 ANAL00262 ANAL00263 ANAL00264 ANAL00265 ANAL00266 ANAL00269 ANAL00270 ANAL00271 ANAL00272 ANAL00273 ANAL00274 ANAL00275 ANAL00279 ANAL00295 ANAL00296 ANAL00308 ANAL00309 ANAL00311 ANAL00312 ANAL00313 ANAL00314 ANAL00315 ANAL00316 ANAL00317 ANAL00318 ANAL00319 ANAL00320 ANAL00321 ANAL00322 ANAL00323 ANAL00324 ANAL00325 ANAL00326 ANAL00327 ANAL00328 ANAL00329 ANAL00330 ANAL00331 ANAL00332 ANAL00333 ANAL00334 ANAL00335 ANAL00336 ANAL00337 ANAL00338 ANAL00339 ANAL00340 ANAL00341 ANAL00342 ANAL00343 ANAL00344 ANAL00345 ANAL00346 ANAL00347 ANAL00348 ANAL00349 ANAL00350 ANAL00351 ANAL00353 ANAL00354 ANAL00355 ANAL00356 ANAL00357 ANAL00358 ANAL00361 ANAL00362 ANAL00363 ANAL00364 ANAL00365 ANAL00366 ANAL00367 ANAL00368 ANAL00369 ANAL00370 ANAL00371 ANAL00372 ANAL00373 ANAL00380 ANAL00381 ANAL00384 ANAL00385 ANAL00386 ANAL00387 ANAL00388 ANAL00389 ANAL00390 ANAL00391 ANAL00392 ANAL00393 ANAL00394 ANAL00397 ANAL00398 ANAL00404 ANAL00405 ANAL00406 ANAL00407 ANAL00408 ANAL00409 ANAL00410 ANAL00411 ANAL00412 ANAL00416 ANAL00417 ANAL00418 ANAL00422 ANAL00423 ANAL00424 ANAL00426 ANAL00427 ANAL00428 ANAL00429 ANAL00430 ANAL00431 ANAL00433 ANAL00434 ANAL00435 ANAL00436 ANAL00437 ANAL00438 ANAL00439 ANAL00444 ANAL00445 ANAL00446 ANAL00447 ANAL00448 ANAL00449 ANAL00450 ANAL00451 ANAL00452 ANAL00453 ANAL00454 ANAL00455 ANAL00456 ANAL00461 ANAL00462 ANAL00463 ANAL00464 ANAL00480 ANAL00481 ANAL00482 ANAL00483 ANAL00484 ANAL00485 ANAL00486 ANAL00487 ANAL00490 ANAL00491 ANAL00492 ANAL00493 ANAL00494 ANAL00495 ANAL00496 ANAL00497 ANAL00498 ANAL00499 ANAL00500 ANAL00501 ANAL00502 ANAL00509 ANAL00510 ANAL00511 ANAL00512 ANAL00513 ANAL00514 ANAL00515 ANAL00516 ANAL00517 ANAL00518 ANAL00519 ANAL00520 ANAL00521 ANAL00522 ANAL00523 ANAL00524 ANAL00525 ANAL00526 ANAL00527 ANAL00528 ANAL00529 ANAL00530 ANAL00551 ANAL00552 ANAL00559 ANAL00573 ANAL00574 ANAL00575 ANAL00576 ANAL00577 ANAL00578 ANAL00579 ANAL00580 ANAL00581 ANAL00582 ANAL00583 ANAL00586 ANAL00589 ANAL00590 ANAL00591 ANAL00597 ANAL00598 ANAL00599 ANAL00600 ANAL00601 ANAL00623 ANAL00624 ANAL00626 ANAL00631 ANAL00632 ANAL00633 ANAL00634 ANAL00635 ANAL00636 ANAL00638 ANAL00639 ANAL00640 ANAL00641 ANAL00642 ANAL00643 ANAL00644 ANAL00645 ANAL00646 ANAL00647 ANAL00649 ANAL00650 ANAL00651 ANAL00654 ANAL00662 ANAL00663 ANAL00664 ANAL00665 ANAL00666 ANAL00669 ANAL00670 ANAL00671 ANAL00672 ANAL00673 ANAL00674 ANAL00675 ANAL00676 ANAL00677 ANAL00678 ANAL00679 ANAL00680 ANAL00681 ANAL00682 ANAL00683 ANAL00684 ANAL00685 ANAL00686 ANAL00687 ANAL00688 ANAL00689 ANAL00690 ANAL00691 ANAL00692 ANAL00693 ANAL00694 ANAL00695 ANAL00696 ANAL00697 ANAL00698 ANAL00699 ANAL00700 ANAL00701 ANAL00702 ANAL00703 ANAL00704 ANAL00705 ANAL00706 ANAL00707 ANAL00708 ANAL00709 ANAL00710 ANAL00711 ANAL00712 ANAL00713 ANAL00717 ANAL00718 ANAL00719 ANAL00720 ANAL00722 ANAL00723 ANAL00724 ANAL00725 ANAL00726 ANAL00727 ANAL00728 ANAL00735 ANAL00736 ANAL00737 ANAL00738 ANAL00739 ANAL00746 ANAL00749 ANAL00750 ANAL00751 ANAL00752 ANAL00753 ANAL00754 ANAL00755 ANAL00756 ANAL00757 ANAL00763 ANAL00764 ANAL00765 ANAL00766 ANAL00769 ANAL00772 ANAL00773 ANAL00774 ANAL00775 ANAL00776 ANAL00777 ANAL00778 ANAL00779 ANAL00780 ANAL00781 ANAL00782 ANAL00783 ANAL00784 ANAL00785 ANAL00786 ANAL00787 ANAL00788 ANAL00789 ANAL00790 ANAL00791 ANAL00792 ANAL00801 ANAL00802 ANAL00803 ANAL00804 ANAL00805 ANAL00810 ANAL00811 ANAL00812 ANAL00813 ANAL00814 ANAL00815 ANAL00816 ANAL00817 ANAL00818 ANAL00819 ANAL00820 ANAL00821 ANAL00822 ANAL00823 ANAL00824 ANAL00825 ANAL00826 ANAL00827 ANAL00828 ANAL00829 ANAL00830 ANAL00831 ANAL00835 ANAL00836 ANAL00837 ANAL00838 ANAL00839 ANAL00840 ANAL00841 ANAL00842 ANAL00843 ANAL00844 ANAL00845 ANAL00846 ANAL00847 ANAL00848 ANAL00849 ANAL00871 ANAL00872 ANAL00873 ANAL00874 ANAL00875 ANAL00879 ANAL00880 ANAL00881 ANAL00882 ANAL00883 ANAL00884 ANAL00885 ANAL00886 ANAL00887 ANAL00888 ANAL00889 ANAL00890 ANAL00891 ANAL00892 ANAL00893 ANAL00896 ANAL00897 ANAL00898 ANAL00899 ANAL00900 ANAL00901 ANAL00917 ANAL00918 ANAL00919 ANAL00920 ANAL00921 ANAL00922 ANAL00923 ANAL00924 ANAL00931 ANAL00932 ANAL00933 ANAL00934 ANAL00935 ANAL00936 ANAL00937 ANAL00938 ANAL00939 ANAL00940 ANAL00941 ANAL00942 ANAL00943 ANAL00944 ANAL00945 ANAL00946 ANAL00947 ANAL00948 ANAL00949 ANAL00950 ANAL00951 ANAL00952 ANAL00953 ANAL00954 ANAL00955 ANAL00956 ANAL00957 ANAL00958 ANAL00959 ANAL00960 ANAL00961 ANAL00962 ANAL00963 ANAL00964 ANAL00965 ANAL00966 ANAL00967 ANAL00968 ANAL00969 ANAL00970 ANAL00971 ANAL00972 ANAL00973 ANAL00974 ANAL00975 ANAL00976 ANAL00977 ANAL00978 ANAL00979 ANAL00980 ANAL00981 ANAL00982 ANAL00983 ANAL00984 ANAL00985 ANAL00986 ANAL00987 ANAL00988 ANAL00989 ANAL00990 ANAL00991 ANAL00992 ANAL00993 ANAL00994 ANAL00995 ANAL00996 ANAL00997 ANAL00998 ANAL00999 ANAL01000 ANAL01001 ANAL01002 ANAL01007 ANAL01008 ANAL01009 ANAL01010 ANAL01011 ANAL01012 ANAL01014 ANAL01015 ANAL01016 ANAL01017 ANAL01018 ANAL01019 ANAL01020 ANAL01021 ANAL01022 ANAL01023 ANAL01024 ANAL01025 ANAL01026 ANAL01027 ANAL01028 ANAL01036 ANAL01038 ANAL01039 ANAL01040 ANAL01041 ANAL01042 ANAL01043 ANAL01044 ANAL01045 ANAL01046 ANAL01047 ANAL01048 ANAL01049 ANAL01050 ANAL01051 ANAL01052 ANAL01053 ANAL01054 ANAL01055 ANAL01056 ANAL01057 ANAL01058 ANAL01059 ANAL01060 ANAL01061 ANAL01062 ANAL01063 ANAL01064 ANAL01065 ANAL01066 ANAL01067 ANAL01068 ANAL01069 ANAL01070 ANAL01071 ANAL01072 ANAL01073 ANAL01074 ANAL01075 ANAL01076 ANAL01077 ANAL01078 ANAL01079 ANAL01080 ANAL01081 ANAL01082 ANAL01083 ANAL01084 ANAL01085 ANAL01086 ANAL01087 ANAL01088 ANAL01089 ANAL01090 ANAL01091 ANAL01092 ANAL01093 ANAL01094 ANAL01099 ANAL01107 ANAL01108 ANAL01109 ANAL01110 ANAL01111 ANAL01112 ANAL01113 ANAL01114 ANAL01115 ANAL01116 ANAL01117 ANAL01118 ANAL01119 ANAL01120 ANAL01121 ANAL01122 ANAL01123 ANAL01124 ANAL01125 ANAL01126 ANAL01127 ANAL01128 ANAL01129 ANAL01131 ANAL01132 ANAL01133 ANAL01134 ANAL01135 ANAL01136 ANAL01137 ANAL01138 ANAL01139 ANAL01140 ANAL01141 ANAL01142 ANAL01143 ANAL01144 ANAL01145 ANAL01146 ANAL01147 ANAL01148 ANAL01149 ANAL01150 ANAL01151 ANAL01173 ANAL01184 ANAL01185 ANAL01186 ANAL01187 ANAL01188 ANAL01189 ANAL01190 ANAL01191 ANAL01192 ANAL01193 ANAL01194 ANAL01195 ANAL01196 ANAL01197 ANAL01198 ANAL01199 ANAL01200 ANAL01201 ANAL01202 ANAL01203 ANAL01204 ANAL01205 ANAL01206 ANAL01207 ANAL01208 ANAL01209 ANAL01210 ANAL01211 ANAL01212 ANAL01213 ANAL01214 ANAL01215 ANAL01216 ANAL01217 ANAL01218 ANAL01219 ANAL01220 ANAL01221 ANAL01222 ANAL01223 ANAL01224 ANAL01225 ANAL01226 ANAL01227 ANAL01228 ANAL01229 ANAL01230 ANAL01231 ANAL01232 ANAL01233 ANAL01234 ANAL01235 ANAL01236 ANAL01237 ANAL01238 ANAL01239 ANAL01240 ANAL01241 ANAL01242 ANAL01243 ANAL01244 ANAL01245 ANAL01246 ANAL01254 ANAL01255 ANAL01258 ANAL01259 ANAL01279 ANAL01287 ANAL01288 ANAL01289 ANAL01290 ANAL01291 ANAL01292 ANAL01293 ANAL01294 ANAL01295 ANAL01296 ANAL01297 ANAL01298 ANAL01299 ANAL01300 ANAL01301 ANAL01302 ANAL01303 ANAL01304 ANAL01305 ANAL01306 ANAL01308 ANAL01325 ANAL01326 ANAL01327 ANAL01328 ANAL01329 ANAL01336 ANAL01337 ANAL01338 ANAL01339 ANAL01340 ANAL01341 ANAL01345 ANAL01346 ANAL01347 ANAL01348 ANAL01349 ANAL01350 ANAL01366 ANAL01367 ANAL01368 ANAL01369 ANAL01371 ANAL01372 ANAL01374 ANAL01375 ANAL01376 ANAL01377 ANAL01378 ANAL01379 ANAL01383 ANAL01384 ANAL01385 ANAL01386 ANAL01387 ANAL01388 ANAL01389 ANAL01390 ANAL01391 ANAL01394 ANAL01395 ANAL01397 ANAL01398 ANAL01399 ANAL01400 ANAL01401 ANAL01402 ANAL01403 ANAL01404 ANAL01405 ANAL01406 ANAL01407 ANAL01408 ANAL01409 ANAL01410 ANAL01415 ANAL01416 ANAL01418 ANAL01426 ANAL01427 ANAL01428 ANAL01429 ANAL01430 ANAL01431 ANAL01432 ANAL01433 ANAL01434 ANAL01435 ANAL01436 ANAL01437 ANAL01438 ANAL01439 ANAL01440 ANAL01441 ANAL01442 ANAL01443 ANAL01444 ANAL01445 ANAL01446 ANAL01447 ANAL01448 ANAL01449 ANAL01450 ANAL01451 ANAL01452 ANAL01453 ANAL01454 ANAL01455 ANAL01456 ANAL01457 ANAL01458 ANAL01461 ANAL01462 ANAL01463 ANAL01464 ANAL01465 ANAL01467 ANAL01468 ANAL01469 ANAL01470 ANAL01471 ANAL01472 ANAL01473 ANAL01474 ANAL01475 ANAL01476 ANAL01477 ANAL01478 ANAL01479 ANAL01480 ANAL01481 ANAL01482 ANAL01483 ANAL01486 ANAL01487 ANAL01488 ANAL01489 ANAL01490 ANAL01491 ANAL01492 ANAL01493 ANAL01494 ANAL01495 ANAL01496 ANAL01497 ANAL01498 ANAL01499 ANAL01500 ANAL01501 ANAL01502 ANAL01506 ANAL01508 ANAL01509 ANAL01510 ANAL01511 ANAL01512 ANAL01513 ANAL01514 ANAL01515 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ANAN01177 ANAN01178 ANAN01179 ANAN01183 ANAN01184 ANAN01185 ANAP00100 ANAP00101 ANAP00102 ANAP00107 ANAP00108 ANAP00109 ANAP00110 ANAP00111 ANAP00112 ANAP00123 ANAP00124 ANAP00125 ANAP00126 ANAP00127 ANAP00128 ANAP00129 ANAP00130 ANAP00131 ANAP00132 ANAP00133 ANAP00134 ANAP00135 ANAP00136 ANAP00137 ANAP00138 ANAP00139 ANAP00140 ANAP00141 ANAP00142 ANAP00149 ANAP00152 ANAP00159 ANAP00160 ANAP00161 ANAP00162 ANAP00163 ANAP00164 ANAP00165 ANAP00166 ANAP00167 ANAP00168 ANAP00187 ANAP00188 ANAP00189 ANAP00209 ANAP00211 ANAP00212 ANAP00213 ANAP00214 ANAP00215 ANAP00216 ANAP00217 ANAP00218 ANAP00219 ANAP00220 ANAP00221 ANAP00227 ANAP00228 ANAP00229 ANAP00230 ANAP00231 ANAP00232 ANAP00233 ANAP00234 ANAP00235 ANAP00236 ANAP00240 ANAP00241 ANAP00242 ANAP00243 ANAP00245 ANAP00246 ANAP00247 ANAP00248 ANAP00249 ANAP00250 ANAP00251 ANAP00254 ANAP00257 ANAP00258 ANAP00259 ANAP00263 ANAP00264 ANAP00265 ANAP00266 ANAP00292 ANAP00293 ANAP00296 ANAP00297 ANAP00302 ANAP00311 ANAP00312 ANAP00313 ANAP00314 ANAP00315 ANAP00316 ANAP00317 ANAP00318 ANAP00319 ANAP00320 ANAP00321 ANAP00322 ANAP00323 ANAP00324 ANAP00325 ANAP00326 ANAP00327 ANAP00344 ANAP00345 ANAP00346 ANAP00347 ANAP00348 ANAP00349 ANAP00350 ANAP00351 ANAP00352 ANAP00353 ANAP00354 ANAP00355 ANAP00356 ANAP00357 ANAP00358 ANAP00359 ANAP00360 ANAP00361 ANAP00362 ANAP00363 ANAP00364 ANAP00365 ANAP00366 ANAP00367 ANAP00368 ANAP00369 ANAP00370 ANAP00371 ANAP00372 ANAP00373 ANAP00374 ANAP00375 ANAP00376 ANAP00377 ANAP00378 ANAP00379 ANAP00380 ANAP00381 ANAP00382 ANAP00383 ANAP00384 ANAP00385 ANAP00386 ANAP00387 ANAP00388 ANAP00389 ANAP00390 ANAP00396 ANAP00405 ANAP00408 ANAP00421 ANAP00423 ANAP00424 ANAP00425 ANAP00427 ANAP00428 ANAP00429 ANAP00430 ANAP00431 ANAP00432 ANAP00433 ANAP00434 ANAP00437 ANAP00438 ANAP00439 ANAP00440 ANAP00441 ANAP00477 ANAP00478 ANAP00480 ANAP00481 ANAP00482 ANAP00483 ANAP00484 ANAP00485 ANAP00486 ANAP00487 ANAP00488 ANAP00489 ANAP00490 ANAP00491 ANAP00504 ANAP00505 ANAP00506 ANAP00507 ANAP00508 ANAP00509 ANAP00510 ANAP00511 ANAP00512 ANAP00513 ANAP00514 ANAP00515 ANAP00516 ANAP00522 ANAP00527 ANAP00528 ANAP00530 ANAP00540 ANAP00560 ANAP00561 ANAP00562 ANAP00563 ANAP00570 ANAP00584 ANAP00585 ANAP00586 ANAP00587 ANAP00588 ANAP00589 ANAP00606 ANAP00607 ANAP00608 ANAP00609 ANAP00635 ANAP00636 ANAP00637 ANAP00638 ANAP00672 ANAP00673 ANAP00674 ANAP00675 ANAP00676 ANAP00677 ANAP00678 ANAP00679 ANAP00726 ANAP00727
Recalling Firm/
Manufacturer
GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha, Wisconsin 53188-1615
Manufacturer Reason
for Recall
Users may inadvertently leave a test plug in the inspiratory flow sensor after completing Low P Leak Check on the SCGO (Switched Common Gas Outlet) configuration of Avance, Amingo, and Aisys anesthesia machines that may impact patient safety. If the test plug remains in place and therapy is initiated, the machine will not provide gas to the patient. This would inhibit mechanical or manual ventila
FDA Determined
Cause 2
TRAINING: Employee Error
Action GE Healthcare issued an " Urgent Medical Device Correction" letter dated August 30, 2010 to consignees. The letter was addressed to Chief of Anesthesia, Health Care Administrator/Risk Manager and Director of Biomedical/ Clinical Engineering. The letter described the Safety Issue, Affected Product Details, Safety Instructions, Product Correction and Contact Instructions. Customers were instructed to: 1. Ensure the plug is removed at the completion of the Low P Leak check. 2. Review the Preoperative Checkout procedure listed in section 4 of the User Reference Manual with appropriate personnel. Ensure that the Preoperative Checkout procedure is completed in its entirety prior to each case, or as required. All facilities will be contacted by their local GE GE Field Technical Service Team to schedule installation of a software update and a revised test plug for your machines configured with SCGO. Customers are to contact their local GE Healthcare Customer or Technical Support Representative if they need additional information.
Quantity in Commerce 3039
Distribution Worldwide Distribution: USA: All States, including DC, except Delaware, and the countries of YEMEN, VIETNAM, VENEZUELA, UNITED KINGDOM, UNITED ARAB EMIRATES, TURKEY, THAILAND, SYRIA, SWITZERLAND, SWEDEN, SPAIN, SOUTH AFRICA, SLOVENIA, SLOVAKIA, SINGAPORE, SERBIA, SAUDI, ARABIA, RUSSIA, PORTUGAL POLAND, PERU, PANAMA, NORWAY, NETHERLAND, MACEDONIA, LITHUANIA, LEBANON, LATVIA, KUWAIT, KOREA, KENYA, JORDAN, JAPAN, ITALY, IRELAND, INDIA, HUNGARIA, HONG KONG, HONDURAS, GREECE, GERMANY, FRANCE, FINLAND, ESTONIA, EGYPT, DENMARK, CZECH REPUBLIC, CROATIA, COLOMBIA, CHINA, CHILE, CANADA, BULGARIA, BRAZIL, BERMUDA, BELGIUM, AUSTRIA, AUSTRALIA, and ARGENTINA.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = BSZ and Original Applicant = DATEX-OHMEDA, INC.
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