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U.S. Department of Health and Human Services

Class 2 Device Recall GE DatexOhmeda Aisys

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 Class 2 Recall
GE DatexOhmeda Aisys
see related information
Date Posted October 06, 2008
Recall Status1 Open
Recall Number Z-0020-2009
Recall Event ID 49379
Premarket Notification
510(K) Number
K073707 
Product Classification Gas-Machine, Anesthesia - Product Code BSZ
Product GE Datex-Ohmeda Aisys, Datex-Ohmeda, Inc., a General Electric Company going to market as GE Healthcare, GE Healthcare PO Box 7550, Madison, WI. 53707-7550 Datex-Ohmeda Aisys Intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients. The device is intended for volume or pressure control ventilation. The Aisys is not suitable for use in a MRI environment.
Code Information Short Number ANAK00225 ANAK00890 ANAK00926 ANAL00101 ANAL00102 ANAL00303 ANAK00284 ANAK00285 ANAK00286 ANAK00287 ANAK00288 ANAK00289 ANAK00290 ANAK00291 ANAK00292 ANAK00293 ANAK00294 ANAK00295 ANAK00296 ANAK00298 ANAK00299 ANAK00300 ANAK00301 ANAK00302 ANAK00303 ANAK00304 ANAK00305 ANAK00306 ANAK00307 ANAK00308 ANAK00309 ANAK00310 ANAK00311 ANAK00312 ANAK00313 ANAK00314 ANAK00315 ANAK00316 ANAK00317 ANAK00318 ANAK00319 ANAK00478 ANAK00479 ANAK00480 ANAK00297 ANAL00411 ANAK00774 ANAK00775 ANAL00490 ANAL00491 ANAL00492 ANAL00493 ANAL00494 ANAL00495 ANAL00496 ANAL00497 ANAL00498 ANAL00499 ANAL00500 ANAL00501 ANAL00315 ANAL00316 ANAL00317 ANAL00318 ANAL00319 ANAL00320 ANAL00321 ANAJ00251 ANAJ00248 ANAK00162 ANAK00163 ANAK00164 ANAK00165 ANAK00166 ANAK00167 ANAK00226 ANAK00227 ANAK00228 ANAK00229 ANAK00230 ANAK00231 ANAK00232 ANAK00233 ANAJ00120 ANAJ00121 ANAJ00125 ANAJ00126 ANAJ00127 ANAJ00128 ANAJ00129 ANAJ00134 ANAJ00135 ANAJ00136 ANAJ00137 ANAL00573 ANAL00574 ANAL00575 ANAL00576 ANAL00577 ANAL00578 ANAL00579 ANAL00580 ANAL00581 ANAL00582 ANAL00583 ANAH00115 ANAJ00100 ANAJ00106 ANAJ00110 ANAJ00200 ANAJ00201 ANAJ00204 ANAJ00214 ANAJ00215 ANAJ00216 ANAJ00217 ANAJ00218 ANAJ00219 ANAJ00220 ANAJ00221 ANAJ00222 ANAJ00223 ANAJ00224 ANAJ00225 ANAJ00226 ANAJ00227 ANAJ00231 ANAJ00232 ANAJ00233 ANAJ00234 ANAJ00235 ANAJ00236 ANAJ00237 ANAJ00238 ANAJ00239 ANAJ00240 ANAJ00241 ANAJ00242 ANAJ00243 ANAJ00244 ANAJ00245 ANAJ00246 ANAJ00247 ANAJ00249 ANAJ00250 ANAL00121 ANAK00409 ANAL00248 ANAL00426 ANAL00427 ANAL00428 ANAL00429 ANAL00430 ANAL00431 ANAL00433 ANAL00434 ANAL00435 ANAL00436 ANAL00437 ANAL00438 ANAL00439 ANAL00209 ANAL00210 ANAL00416 ANAL00417 ANAL00418 ANAL00167 ANAL00215 ANAL00216 ANAL00217 ANAL00218 ANAL00219 ANAL00220 ANAL00221 ANAL00222 ANAL00223 ANAL00224 ANAL00225 ANAL00226 ANAL00227 ANAL00228 ANAK00638 ANAK00639 ANAK00659 ANAK00660 ANAK00661 ANAK00662 ANAK00663 ANAK00664 ANAK00665 ANAL00211 ANAL00212 ANAL00213 ANAL00214 ANAK00506 ANAK00724 ANAK00725 ANAK00726 ANAL00623 ANAL00624 ANAK00748 ANAK00749 ANAK00750 ANAK00751 ANAK00752 ANAK00753 ANAK00754 ANAK00755 ANAK00756 ANAL00202 ANAL00203 ANAL00204 ANAL00205 ANAL00206 ANAL00207 ANAL00208 ANAK00238 ANAK00239 ANAL00480 ANAL00481 ANAL00482 ANAL00483 ANAL00484 ANAL00485 ANAL00486 ANAL00487 ANAJ00141 ANAJ00142 ANAJ00164 ANAJ00165 ANAJ00166 ANAJ00167 ANAJ00168 ANAJ00169 ANAJ00170 ANAJ00171 ANAJ00172 ANAJ00173 ANAJ00174 ANAJ00175 ANAJ00176 ANAJ00177 ANAJ00178 ANAK00160 ANAK00202 ANAK00203 ANAK00121 ANAK00241 ANAK00402 ANAK00403 ANAK00404 ANAK00405 ANAK00406 ANAK00407 ANAK00408 ANAK00590 ANAL00651 ANAL00508 ANAL00509 ANAK00269 ANAJ00105 ANAL00638 ANAL00639 ANAL00640 ANAL00641 ANAK00526 ANAK00527 ANAK00528 ANAK00529 ANAK00530 ANAK00762 ANAK00763 ANAK00764 ANAK00765 ANAJ00179 ANAK00658 ANAJ00143 ANAL00586 ANAL00589 ANAL00590 ANAL00591 ANAL00461 ANAL00462 ANAL00463 ANAL00464 ANAK00322 ANAK00323 ANAL00649 ANAL00650 ANAK00640 ANAK00641 ANAK00681 ANAK00682 ANAK00683 ANAK00689 ANAL00122 ANAL00123 ANAL00124 ANAL00125 ANAJ00109 ANAJ00112 ANAJ00196 ANAJ00266 ANAJ00267 ANAK00266 ANAK00275 ANAK00276 ANAK00277 ANAK00278 ANAK00324 ANAL00166 ANAL00354 ANAL00356 ANAK00887 ANAK00888 ANAK00889 ANAK00358 ANAK00359 ANAK00360 ANAK00361 ANAK00362 ANAK00363 ANAK00364 ANAK00365 ANAK00366 ANAK00367 ANAK00393 ANAK00394 ANAK00395 ANAK00906 ANAK00907 ANAK00908 ANAK00909 ANAK00910 ANAJ00253 ANAJ00254 ANAJ00255 ANAK00847 ANAK00848 ANAK00849 ANAK00800 ANAK00801 ANAK00811 ANAK00816 ANAK00818 ANAK00828 ANAK00844 ANAK00853 ANAK00866 ANAK00867 ANAK00868 ANAK00871 ANAK00875 ANAK00877 ANAK00882 ANAK00802 ANAK00805 ANAK00806 ANAK00808 ANAK00810 ANAK00812 ANAK00813 ANAK00815 ANAK00817 ANAK00819 ANAK00820 ANAK00821 ANAK00822 ANAK00823 ANAK00824 ANAK00825 ANAK00826 ANAK00827 ANAK00829 ANAK00830 ANAK00831 ANAK00832 ANAK00833 ANAK00834 ANAK00835 ANAK00836 ANAK00837 ANAK00838 ANAK00840 ANAK00841 ANAK00842 ANAK00843 ANAK00845 ANAK00861 ANAK00863 ANAK00864 ANAK00865 ANAK00869 ANAK00870 ANAK00872 ANAK00873 ANAK00874 ANAK00876 ANAK00878 ANAK00879 ANAK00880 ANAK00881 ANAK00883 ANAK00884 ANAK00885 ANAK00886 ANAK00798 ANAK00799 ANAK00809 ANAK00814 ANAK00839 ANAK00803 ANAK00804 ANAK00807 ANAL00142 ANAL00143 ANAL00144 ANAL00145 ANAK00471 ANAK00320 ANAK00321 ANAK00758 ANAK00759 ANAK00760 ANAK00761 ANAK00771 ANAK00772 ANAK00773 ANAK00776 ANAK00777 ANAK00778 ANAK00779 ANAK00780 ANAK00781 ANAK00782 ANAK00783 ANAK00784 ANAK00785 ANAK00786 ANAK00787 ANAK00788 ANAK00789 ANAK00790 ANAK00791 ANAK00792 ANAL00361 ANAL00362 ANAL00363 ANAL00364 ANAL00365 ANAL00366 ANAL00367 ANAL00368 ANAL00369 ANAL00370 ANAL00371 ANAL00372 ANAL00373 ANAK00368 ANAK00369 ANAK00370 ANAK00371 ANAK00372 ANAK00373 ANAK00374 ANAK00375 ANAK00376 ANAK00377 ANAK00380 ANAK00381 ANAK00382 ANAK00383 ANAK00384 ANAK00385 ANAK00387 ANAK00388 ANAK00389 ANAK00390 ANAK00391 ANAK00392 ANAL00270 ANAK00456 ANAK00457 ANAK00458 ANAK00580 ANAK00581 ANAK00582 ANAK00583 ANAK00584 ANAK00585 ANAK00586 ANAK00587 ANAK00588 ANAK00625 ANAK00626 ANAK00627 ANAK00628 ANAK00629 ANAK00630 ANAK00631 ANAK00632 ANAK00633 ANAK00634 ANAK00635 ANAK00636 ANAK00637 ANAL00384 ANAL00385 ANAL00386 ANAL00387 ANAL00388 ANAL00389 ANAL00390 ANAL00391 ANAL00392 ANAL00393 ANAL00394 ANAK00396 ANAK00397 ANAK00398 ANAK00399 ANAK00400 ANAK00401 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 ANAK00459 ANAK00492 ANAK00465 ANAJ00107 ANAJ00108 ANAJ00111 ANAK00337 ANAK00338 ANAK00339 ANAK00340 ANAK00434 ANAK00435 ANAK00436 ANAK00437 ANAK00438 ANAK00439 ANAK00440 ANAL00190 ANAL00191 ANAL00192 ANAL00193 ANAL00194 ANAL00195 ANAL00196 ANAL00197 ANAK00428 ANAK00429 ANAK00430 ANAK00431 ANAK00432 ANAK00433 ANAL00311 ANAL00312 ANAL00313 ANAL00314 ANAK00156 ANAK00157 ANAK00158 ANAK00159 ANAK00511 ANAK00512 ANAK00513 ANAK00514 ANAK00250 ANAL00269 ANAK00598 ANAK00599 ANAK00600 ANAK00601 ANAK00602 ANAL00156 ANAL00157 ANAL00158 ANAL00664 ANAL00665 ANAK00168 ANAK00169 ANAK00100 ANAK00101 ANAK00102 ANAK00103 ANAK00104 ANAK00105 ANAK00106 ANAK00425 ANAK00426 ANAK00427 ANAK00224 ANAL00626 ANAJ00147 ANAK00279 ANAL00106 ANAL00107 ANAL00108 ANAL00109 ANAL00116 ANAJ00145 ANAJ00205 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 ANAL00642 ANAL00643 ANAL00644 ANAL00645 ANAL00646 ANAL00647 ANAL00551 ANAL00552 ANAH00116 ANAK00643 ANAK00644 ANAK00927 ANAK00928 ANAK00929 ANAK00930 ANAK00931 ANAK00932 ANAK00933 ANAK00934 ANAK00935 ANAK00936 ANAK00937 ANAJ00146 ANAK00260 ANAK00262 ANAK00263 ANAK00273 ANAK00117 ANAL00271 ANAL00272 ANAL00275 ANAL00273 ANAL00274 ANAJ00190 ANAK00111 ANAJ00180 ANAJ00181 ANAJ00182 ANAJ00183 ANAJ00184 ANAJ00185 ANAJ00186 ANAJ00187 ANAJ00188 ANAJ00189 ANAL00449 ANAL00450 ANAL00451 ANAL00452 ANAL00453 ANAL00454 ANAL00455 ANAL00456 ANAH00114 ANAJ00265 ANAJ00197 ANAJ00198 ANAJ00199 ANAJ00202 ANAJ00228 ANAJ00229 ANAJ00230 ANAJ00256 ANAJ00257 ANAJ00258 ANAJ00259 ANAK00254 ANAK00255 ANAK00256 ANAK00257 ANAK00258 ANAJ00195 ANAL00100 ANAL00631 ANAL00632 ANAL00633 ANAL00634 ANAL00635 ANAL00636 ANAL00662 ANAL00663 ANAK00657 ANAK00249 ANAK00463 ANAK00464 ANAK00123 ANAK00124 ANAK00125 ANAK00126 ANAK00127 ANAK00128 ANAK00129 ANAK00130 ANAK00131 ANAK00132 ANAK00133 ANAK00134 ANAK00135 ANAK00136 ANAK00137 ANAK00138 ANAK00139 ANAK00140 ANAK00721 ANAK00722 ANAL00444 ANAL00445 ANAL00446 ANAL00447 ANAL00448 ANAL00404 ANAL00405 ANAL00244 ANAL00146 ANAL00147 ANAL00148 ANAL00149 ANAL00150 ANAL00151 ANAL00152 ANAL00153 ANAL00154 ANAL00155 ANAK00717 ANAJ00101 ANAK00261 ANAK00264 ANAK00268 ANAK00270 ANAK00271 ANAK00272 ANAK00274 ANAL00597 ANAL00598 ANAL00599 ANAL00600 ANAL00601 ANAL00406 ANAL00407 ANAL00408 ANAL00409 ANAL00410 ANAJ00208 ANAJ00209 ANAJ00210 ANAJ00211 ANAJ00212 ANAL00308 ANAK00461 ANAK00710 ANAK00711 ANAK00712 ANAK00713 ANAK00714 ANAK00715 ANAH00125 ANAH00117 ANAJ00102 ANAJ00113 ANAJ00203 ANAJ00264 ANAK00213 ANAK00214 ANAK00242 ANAK00247 ANAK00248 ANAK00259 ANAK00265 ANAK00280 ANAK00325 ANAK00326 ANAK00327 ANAK00922 ANAK00923 ANAK00924 ANAK00925 ANAL00165 ANAL00168 ANAL00246 ANAL00247 ANAL00250 ANAL00251 ANAL00252 ANAL00253 ANAL00254 ANAL00255 ANAL00256 ANAL00257 ANAL00258 ANAL00259 ANAL00260 ANAL00261 ANAL00262 ANAL00263 ANAL00279 ANAL00309 ANAL00353 ANAL00355 ANAL00357 ANAL00358 ANAL00381 ANAL00397 ANAL00398 ANAL00412 ANAL00654 ANAH00124 ANAH00126 ANAK00215 ANAK00345 ANAK00723 ANAK00727 ANAK00728 ANAK00850 ANAK00851 ANAK00852 ANAK00346 ANAK00347 ANAL00380 ANAJ00122 ANAK00615 ANAK00616 ANAK00617 ANAK00618 ANAK00619 ANAK00620 ANAK00621 ANAK00622 ANAK00623 ANAK00509 ANAK00510 ANAL00105 ANAK00591 ANAK00592 ANAK00593 ANAK00594 ANAK00768 ANAK00769 ANAK00770 ANAK00793 ANAK00794 ANAK00795 ANAK00796 ANAK00797 ANAL00637 ANAK00603 ANAK00604 ANAK00605 ANAK00606 ANAK00607 ANAK00608 ANAK00609 ANAK00610 ANAK00611 ANAK00612 ANAK00613 ANAK00614 ANAK00109 ANAK00107 ANAK00108 ANAK00243 ANAK00244 ANAK00246 ANAL00238 ANAK00647 ANAK00648 ANAK00649 ANAK00666 ANAK00667 ANAK00668 ANAK00245 ANAK00422 ANAK00734 ANAK00735 ANAK00736 ANAL00307 ANAK00146 ANAL00432 ANAK00575 ANAK00234 ANAK00470 ANAL00395 ANAL00440 ANAL00441 ANAJ00124 ANAJ00104 ANAJ00123- ANAK00118 ANAK00119 ANAK00120 ANAK00441 ANAK00442 ANAK00443 ANAK00444 ANAK00445 ANAK00446 ANAK00447 ANAK00448 ANAK00449 ANAK00450 ANAK00451 ANAK00452 ANAK00453 ANAK00454 ANAK00455 ANAL00295 ANAL00296 ANAK00207 ANAK00720 ANAL00510 ANAL00511 ANAL00512 ANAL00513 ANAL00514 ANAL00515 ANAL00516 ANAL00517 ANAL00518 ANAL00519 ANAL00520 ANAL00521 ANAL00522 ANAL00523 ANAL00524 ANAL00525 ANAL00526 ANAL00527 ANAL00528 ANAL00529 ANAL00530 ANAL00559 ANAK00281 ANAK00282 ANAK00531 ANAK00532 ANAK00533 ANAK00534 ANAK00535 ANAK00536 ANAK00537 ANAK00538 ANAK00539 ANAK00540 ANAK00541 ANAK00542 ANAK00543 ANAK00544 ANAK00545 ANAK00546 ANAK00547 ANAK00548 ANAK00549 ANAK00550 ANAK00551 ANAK00552 ANAK00553 ANAK00554 ANAK00555 ANAK00556 ANAK00557 ANAK00558 ANAK00559 ANAK00560 ANAK00561 ANAK00562 ANAK00563 ANAK00564 ANAK00565 ANAK00566 ANAK00567 ANAK00568 ANAK00569 ANAK00570 ANAK00571 ANAK00572 ANAK00573 ANAK00742 ANAK00743 ANAL00306 ANAK00466 ANAK00467 ANAK00468 ANAK00469 ANAK00507 ANAK00508 ANAL00278 ANAL00489 ANAL00602 ANAL00603 ANAL00604 ANAL00605 ANAL00606 ANAL00607 ANAL00608 ANAL00609 ANAL00610 ANAL00611 ANAL00612 ANAL00613 ANAL00614 ANAL00625 ANAL00629 ANAL00630 ANAK00854 ANAK00152 ANAK00153 ANAK00154 ANAK00155 ANAK00645 ANAK00646 ANAL00488 ANAL00655 ANAL00656 ANAL00657 ANAL00658 ANAL00659 ANAL00660 ANAK00357 ANAK00341 ANAK00729 ANAK00730 ANAK00731 ANAK00732 ANAK00733 ANAK00283 ANAK00498 ANAK00499 ANAK00500 ANAK00893 ANAK00894 ANAK00895 ANAK00896 ANAK00897 ANAK00898 ANAK00899 ANAK00900 ANAK00901 ANAK00902 ANAK00335 ANAK00336 ANAK00654 ANAK00655 ANAK00656 ANAJ00114 ANAK00216 ANAK00766 ANAK00767 ANAK00212 ANAL00277 ANAJ00118 ANAK00211 ANAL00276 ANAK00423 ANAJ00117 ANAK00576 ANAK00577 ANAK00578 ANAJ00103 ANAL00533 ANAL00547 ANAL00548 ANAL00549 ANAL00550 ANAL00553 ANAL00554 ANAL00555 ANAL00556 ANAL00557 ANAL00558 ANAL00565 ANAJ00206 ANAK00460 ANAK00501 ANAK00502 ANAK00855 ANAK00856 ANAK00857 ANAK00858 ANAK00859 ANAK00860 ANAK00862 ANAK00913 ANAK00914 ANAK00915 ANAK00916 ANAK00917 ANAK00918 ANAK00919 ANAK00920 ANAL00128 ANAL00129 ANAL00130 ANAL00131 ANAL00132 ANAL00133 ANAL00134 ANAL00135 ANAL00136 ANAL00137 ANAL00138 ANAL00139 ANAL00231 ANAL00232 ANAL00233 ANAL00234 ANAL00235 ANAL00236 ANAL00237 ANAL00103 ANAL00111 ANAL00112 ANAL00113 ANAL00114 ANAK00150 ANAK00151 ANAK00217 ANAK00218 ANAK00219 ANAK00220 ANAK00504 ANAK00505 ANAK00348 ANAK00349 ANAK00350 ANAK00351 ANAK00352 ANAK00353 ANAK00235 ANAL00374 ANAL00375 ANAL00376 ANAL00402 ANAL00403 ANAL00546 ANAK00424 ANAL00401 ANAL00267 ANAK00221 ANAK00222 ANAL00652 ANAL00653 ANAK00208 ANAK00209 ANAK00210 ANAK00718 ANAK00719 ANAK00737 ANAK00738 ANAK00739 ANAK00740 ANAK00741 ANAL00162 ANAL00163 ANAL00164 ANAL00299 ANAL00300 ANAL00301 ANAL00302 ANAL00303 ANAL00304 ANAL00305 ANAL00352 ANAL00592 ANAL00593 ANAL00594 ANAL00595 ANAL00596 ANAJ00252 ANAK00161 ANAL00458 ANAJ00119 ANAK00251 ANAK00252 ANAK00589 ANAK00891 ANAK00892 ANAL00159 ANAL00183 ANAL00185 ANAL00186 ANAL00187 ANAL00502 ANAJ00191 ANAJ00194 ANAK00142 ANAK00143 ANAK00144 ANAK00145 ANAK00205 ANAK00379 ANAK00493 ANAK00494 ANAK00518 ANAK00519 ANAK00521 ANAK00522 ANAK00747 ANAL00239 ANAL00240 ANAL00413 ANAL00414 ANAL00415 ANAL00419 ANAL00587 ANAK00204 ANAL00245 ANAK00515 ANAK00516 ANAK00520 ANAK00574 ANAL00118 ANAL00119 ANAL00120 ANAK00523 ANAK00524 ANAK00344 ANAL00588 ANAK00595 ANAK00596 ANAK00597 ANAL00560 ANAL00561 ANAL00562 ANAL00563 ANAL00564 ANAK00744 ANAK00745 ANAK00746 ANAL00160 ANAL00161 ANAL00115 ANAK00147 ANAK00148 ANAJ00262 ANAJ00263 ANAK00206 ANAK00378 ANAK00517 ANAK00525 ANAL00104 ANAL00110 ANAK00354 ANAK00355 ANAK00356 ANAL00566 ANAL00567 ANAL00568 ANAL00569 ANAL00570 ANAL00571 ANAL00572 ANAL00459 ANAL00460 ANAJ00192 ANAJ00193 ANAJ00207 ANAK00237 ANAL00425 ANAK00149 ANAL00420 ANAK00678 ANAK00679 ANAL00249 ANAL00627 ANAL00628 ANAL00298 ANAL00310 ANAL00661 ANAL00421 ANAL00503 ANAL00504 ANAL00505 ANAL00506 ANAL00507 ANAJ00116 ANAL00268 ANAL00457 ANAK00386 ANAK00669 ANAK00670 ANAK00671 ANAK00672 ANAK00673 ANAK00674 ANAK00675 ANAK00676 ANAK00677 ANAK00680 ANAK00690 ANAK00691 ANAK00692 ANAK00693 ANAK00694 ANAK00695 ANAK00696 ANAK00697 ANAK00698 ANAK00699 ANAK00700 ANAK00701 ANAJ00115 ANAK00653 ANAK00716 ANAK00267 ANAK00650 ANAK00651 ANAK00652 ANAK00911 ANAK00912 ANAL00360 ANAJ00123 ANAL00198 ANAL00648 ANAJ00144 ANAJ00160 ANAK00684 ANAK00685 ANAK00686 ANAK00687 ANAK00688 ANAL00280 ANAL00282 ANAL00283 ANAL00285 ANAK00116 ANAK00702 ANAL00286 ANAL00287 ANAL00288 ANAL00289 ANAL00290 ANAL00291 ANAL00292 ANAL00293 ANAL00294 ANAJ00131 ANAJ00133 ANAK00110 ANAK00111 ANAK00112 ANAK00113 ANAK00114 ANAK00115 ANAL00169 ANAJ00132 ANAK00112 ANAK00223 ANAL00170 ANAL00171 ANAL00172 ANAL00173 ANAL00174 ANAL00175 ANAL00176 ANAL00177 ANAL00178 ANAL00179 ANAL00180 ANAL00181 ANAL00182 ANAL00184 ANAL00188 ANAL00189 ANAL00281 ANAL00284 ANAK00236 ANAJ00138 ANAJ00139 ANAJ00140 ANAJ00148 ANAJ00149 ANAJ00150 ANAJ00151 ANAJ00152 ANAJ00153 ANAJ00154 ANAJ00155 ANAJ00156 ANAJ00157 ANAJ00158 ANAJ00159 ANAJ00161 ANAJ00162 ANAJ00163 ANAL00359 ANAL00127 ANAL00442 ANAL00443 ANAK00122 ANAK00141 ANAK00757 ANAK00921 ANAL00117 ANAL00584 ANAL00585 ANAK00329 ANAK00330 ANAK00331 ANAK00332 ANAK00333 ANAK00334 ANAK00342 ANAK00476 ANAK00477 ANAK00496 ANAK00497 ANAK00503 ANAK00624 ANAK00642 ANAK00903 ANAK00904 ANAK00905 ANAL00199 ANAL00229 ANAL00230 ANAL00241 ANAL00242 ANAL00243 ANAL00379 ANAL00396 ANAL00399 ANAL00400 ANAL00531 ANAL00532 ANAJ00260 ANAK00343 ANAK00579 ANAK00846 ANAL00126 ANAL00200 ANAL00201 ANAL00422 ANAL00423 ANAL00424 ANAJ00213 ANAJ00261 ANAK00472 ANAL00140 ANAL00141 ANAL00471 ANAL00475 ANAL00465 ANAL00466 ANAL00467 ANAL00468 ANAL00469 ANAL00470 ANAL00472 ANAL00473 ANAL00474 ANAL00476 ANAL00477 ANAL00478 ANAL00479 ANAL00534 ANAL00535 ANAL00536 ANAL00537 ANAL00538 ANAL00539 ANAL00540 ANAL00541 ANAL00542 ANAL00543 ANAL00544 ANAL00545 ANAL00264 ANAL00265 ANAL00266 ANAK00410 ANAK00411 ANAK00412 ANAK00413 ANAK00414 ANAK00415 ANAK00416 ANAK00417 ANAK00418 ANAK00419 ANAK00420 ANAK00421 ANAK00703 ANAK00704 ANAK00705 ANAK00706 ANAK00707 ANAK00708 ANAK00709 ANAK00462 ANAK00481 ANAK00482 ANAK00483 ANAK00484 ANAK00485 ANAK00486 ANAK00487 ANAK00488 ANAK00489 ANAK00490 ANAK00491 ANAK00253 ANAL00615 ANAL00616 ANAL00617 ANAL00618 ANAL00619 ANAL00620 ANAL00621, and ANAL00622
Recalling Firm/
Manufacturer
Datex - Ohmeda, Inc
Manufacturer Reason
for Recall
The electronic vaporization system in the GE Aisys Anesthesia machine contains the following components: Backpressure Valve, Inflow Check Valve and Cassette Interface Board, that can contribute to independent failures.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Manufacturing Material Removal
Action GE Healthcare "Urgent Medical Device Correction" letters dated 8/12/08 were sent on 8/20/08 individually to Health Administrator/Risk Manger, Head of Anesthesia and Director of Clinical Engineering. The letters described the Safety Issue, Affected Product Details, Safety Instructions, Product Correction and Contact Information. The Safety Instructions state that the machines can be safely used as long as the following guidelines are followed: 1. Carry out the daily system checkout for any system in use. 2. The Aisys Anesthesia will alert the user both visually and audibly if it detects a fault condition. 3. Have an alternative method of anesthesia available at all times. Once each machine has been corrected an "Update" will be provided by the service technician responsible for the correction. Each customer/machine will receive a "GE Healthcare Urgent Medical Device Correction Update" letter which informs the customer that this correction is a follow-up activity to the letter that was sent earlier.
Quantity in Commerce 1571
Distribution Worldwide Distribution --- USA including states of AL, AK, CA, CO, FL, GA, IL, IN, KS, KY, ME , MD, MA, MI, MO, MT, NE, NV, NH, NY, NC, OH, OK, SC, SD, TX, VA, WV, WI, and DC, and countries of SOUTH AFRICA, TURKEY, THAILAND, SINGAPORE, SWEDEN, SAUDI ARABIA, QATAR, PORTUGAL POLAND, NEW ZEALAND, NORWAY, NETHERLANDS, MEXICO, LIBYA, KUWAIT, KOREA, JAPAN, JORDAN, ITALY, UNITED KINGDOM, FRANCE FINLAND, SPAIN, ESTONIA, DENMARK, GERMANY, COLOMBIA, CHINA, SWITZERLAND, CANADA, BRAZIL, BAHRAIN, BELGIUM, AUSTRALIA, AUSTRIA, and UNITED ARAB EMIRATES.
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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