Class 2 Device Recall Aisys

• Date Initiated by Firm: February 05, 2009
• Date Posted: June 23, 2009
• Recall Status: Terminated on December 10, 2011
• Recall Number: Z-1425-2009
• Recall Event ID: 51202
• 510(K)Number: K073707
• Product Classification: Gas-Machine, Anesthesia - Product Code BSZ
• Product: GE Datex-Ohmeda Aisys, Anesthesia Gas-Machine.
• Code Information: ANAM00499 ANAM00500 ANAM00501 ANAM00502 ANAM00503 ANAM00504 ANAM00505 ANAM00506 ANAM00507 ANAM00508 ANAM00509 ANAM00510 ANAM00511 ANAM00514 ANAM00515 ANAM00516 ANAM00517 ANAM00520 ANAM00521 ANAM00522 ANAM00523 ANAM00526 ANAM00527 ANAM00528 ANAM00529 ANAM00530 ANAM00531 ANAM00532 ANAM00533 ANAM00537 ANAM00539 ANAM00540 ANAM00541 ANAM00542 ANAM00545 ANAM00546 ANAM00547 ANAM00548 ANAM00549 ANAM00550 ANAM00551 ANAM00553 ANAM00554 ANAM00555 ANAM00556 ANAM00557 ANAM00558 ANAM00559 ANAM00568 ANAM00569 ANAM00570 ANAM00571 ANAM00572 ANAM00573 ANAM00574 ANAM00575 ANAM00576 ANAM00577 ANAM00578 ANAM00579 ANAM00580 ANAM00581 ANAM00582 ANAM00583 ANAM00584 ANAM00585 ANAM00586 ANAM00587 ANAM00588 ANAM00592 ANAM00593 ANAM00594 ANAM00595 ANAM00596 ANAM00597 ANAM00598 ANAM00599 ANAM00600 ANAM00601 ANAM00602 ANAM00603 ANAM00604 ANAM00605 ANAM00606 ANAM00607 ANAM00608 ANAM00609 ANAM00610 ANAM00612 ANAM00613 ANAM00614 ANAM00615 ANAM00616 ANAM00617 ANAM00618 ANAM00619 ANAM00620 ANAM00621 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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 ANAL01507 ANAL01508 ANAL01509 ANAL01510 ANAL01511 ANAL01512 ANAL01513 ANAL01514 ANAL01515 ANAL01516 ANAL01517 ANAL01518 ANAL01519 ANAL01520 ANAL01521 ANAL01522 ANAL01523 ANAL01524 ANAL01525 ANAL01526 ANAL01527 ANAL01528 ANAL01529 ANAL01530 ANAL01531 ANAL01532 ANAL01533 ANAL01534 ANAL01535 ANAL01536 ANAL01537 ANAL01538 ANAL01551 ANAM00109 ANAM00110 ANAM00111 ANAM00112 ANAM00113 ANAM00114 ANAM00115 ANAM00116 ANAM00117 ANAM00118 ANAM00119 ANAM00120 ANAM00121 ANAM00122 ANAM00123 ANAM00126 ANAM00158 ANAM00159 ANAM00160 ANAM00161 ANAM00162 ANAM00163 ANAM00164 ANAM00165 ANAM00166 ANAM00167 ANAM00168 ANAM00169 ANAM00170 ANAM00171 ANAM00172 ANAM00173 ANAM00174 ANAM00175 ANAM00176 ANAM00177 ANAM00187 ANAM00188 ANAM00189 ANAM00190 ANAM00191 ANAM00192 ANAM00193 ANAM00194 ANAM00195 ANAM00196 ANAM00197 ANAM00198 ANAM00199 ANAM00200 ANAM00201 ANAM00206 ANAM00207 ANAM00208 ANAM00227 ANAM00228 ANAM00229 ANAM00230 ANAM00231 ANAM00232 ANAM00233 ANAM00234 ANAM00235 ANAM00236 ANAM00237 ANAM00238 ANAM00239 ANAM00240 ANAM00241 ANAM00242 ANAM00243 ANAM00244 ANAM00245 ANAM00246 ANAM00247 ANAM00248 ANAM00249 ANAM00250 ANAM00251 ANAM00252 ANAM00253 ANAM00263 ANAM00264 ANAM00272 ANAM00273 ANAM00274 ANAM00276 ANAM00277 ANAM00278 ANAM00292 ANAM00293 ANAM00294 ANAM00295 ANAM00296 ANAM00297 ANAM00298 ANAM00299 ANAM00300 ANAM00301 ANAM00302 ANAM00303 ANAM00304 ANAM00305 ANAM00306 ANAM00307 ANAM00308 ANAM00309 ANAM00310 ANAM00311 ANAM00312 ANAM00313 ANAM00314 ANAM00367 ANAM00368 ANAM00369 ANAM00370 ANAM00371 ANAM00372 ANAM00373 ANAM00374 ANAM00377 ANAM00378 ANAM00379 ANAM00380 ANAM00381 ANAM00382 ANAM00383 ANAM00384 ANAM00385 ANAM00386 ANAM00387 ANAM00388 ANAM00389 ANAM00390 ANAM00391 ANAM00392 ANAM00393 ANAM00394 ANAM00395 ANAM00396 ANAM00397 ANAM00398 ANAM00399 ANAM00400 ANAM00401 ANAM00402 ANAM00403 ANAM00404 ANAM00405 ANAM00406 ANAM00407 ANAM00408 ANAM00409 ANAM00410 ANAM00421 ANAM00423 ANAM00424 ANAM00425 ANAM00426 ANAM00427 ANAM00439 ANAM00440 ANAM00441 ANAM00442 ANAM00443 ANAM00444 ANAM00445 ANAM00446 ANAM00447 ANAM00448 ANAM00449 ANAM00450 ANAM00451 ANAM00452 ANAM00453 ANAM00454 ANAM00455 ANAM00456 ANAM00457 ANAM00458 ANAM00463 ANAM00464 ANAM00465 ANAM00466 ANAM00467 ANAM00468 ANAM00469 ANAM00470 ANAM00471 ANAM00472 ANAM00473 ANAM00484 ANAM00485 ANAM00486 ANAM00487 ANAM00488 ANAM00489 ANAM00490 ANAM00491 ANAM00492 ANAM00493 ANAM00494 ANAM00495 ANAM00496 ANAM00497 ANAM00498 ANAM00499 ANAM00500 ANAM00501 ANAM00502 ANAL00796 ANAL00797 ANAL00798 ANAL00799 ANAL00800 ANAK00107 ANAK00108 ANAK00109 ANAK00243 ANAK00244 ANAK00245 ANAK00246 ANAK00422 ANAK00647 ANAK00648 ANAK00649 ANAK00666 ANAK00667 ANAK00668 ANAL00238 ANAL01351 ANAL01352 ANAL01353 ANAL01354 ANAL01355 ANAL01356 ANAL01357 ANAL01358 ANAM00219 ANAM00220 ANAM00221 ANAM00222 ANAM00223 ANAM00224 ANAK00146 ANAK00734 ANAK00735 ANAK00736 ANAL00307 ANAL00432 ANAK00575 ANAJ00124 ANAK00234 ANAK00470 ANAL00395 ANAL00440 ANAL00441 ANAL00748 ANAL01411 ANAJ00104 ANAK00118 ANAK00119 ANAK00120 ANAK00207 ANAK00441 ANAK00442 ANAK00443 ANAK00444 ANAK00445 ANAK00446 ANAK00447 ANAK00448 ANAK00449 ANAK00450 ANAK00451 ANAK00452 ANAK00453 ANAK00454 ANAK00455 ANAK00720 ANAL00295 ANAL00296 ANAL00510 ANAL00511 ANAL00512 ANAL00513 ANAL00514 ANAL00515 ANAL00516 ANAL00517 ANAL00518 ANAL00519 ANAL00520 ANAL00521 ANAL00522 ANAL00523 ANAL00524 ANAL00525 ANAL00526 ANAL00527 ANAL00528 ANAL00529 ANAL00530 ANAL00559 ANAL01366 ANAL01367 ANAL01368 ANAL01369 ANAL01371 ANAL01372 ANAL01374 ANAL01375 ANAL01376 ANAL01377 ANAL01378 ANAL01379 ANAM00127 ANAM00128 ANAM00129 ANAM00130 ANAM00131 ANAM00132 ANAM00133 ANAM00134 ANAM00135 ANAM00136 ANAM00137 ANAM00138 ANAM00139 ANAM00140 ANAM00141 ANAM00142 ANAM00143 ANAM00144 ANAM00145 ANAM00146 ANAM00339 ANAM00340 ANAM00341 ANAM00342 ANAM00343 ANAM00344 ANAM00345 ANAM00346 ANAM00358 ANAM00359 ANAM00360 ANAM00361 ANAM00362 ANAM00363 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 ANAL00767 ANAL01307 ANAK00466 ANAK00467 ANAK00468 ANAK00469 ANAK00507 ANAK00508 ANAL00278 ANAL00489 ANAL00602 ANAL00603 ANAL00604 ANAL00605 ANAL00606 ANAL00607 ANAL00608 ANAL00609 ANAL00610 ANAL00611 ANAL00612 ANAL00613 ANAL00614 ANAL00625 ANAL00629 ANAL00630 ANAL00768 ANAL00858 ANAL00859 ANAL00864 ANAL00925 ANAL00926 ANAL00927 ANAL00928 ANAL00929 ANAL00930 ANAM00265 ANAM00266 ANAM00267 ANAM00268 ANAM00269 ANAM00270 ANAM00271 ANAM00282 ANAM00283 ANAM00284 ANAM00285 ANAM00286 ANAM00287 ANAM00288 ANAM00289 ANAM00290 ANAM00291 ANAK00854 ANAK00152 ANAK00153 ANAK00154 ANAK00155 ANAK00357 ANAK00645 ANAK00646 ANAL00488 ANAL00655 ANAL00656 ANAL00657 ANAL00658 ANAL00659 ANAL00660 ANAL00715 ANAL00716 ANAK00341 ANAK00729 ANAK00730 ANAK00731 ANAK00732 ANAK00733 ANAK00283 ANAK00498 ANAK00499 ANAK00500 ANAK00893 ANAK00894 ANAK00895 ANAK00896 ANAK00897 ANAK00898 ANAK00899 ANAK00900 ANAK00901 ANAK00902 ANAL00907 ANAL00908 ANAL00909 ANAL00910 ANAL00911 ANAL00912 ANAL00913 ANAL00914 ANAL00915 ANAL00916 ANAL01382 ANAM00428 ANAM00429 ANAM00430 ANAM00431 ANAM00432 ANAM00433 ANAM00434 ANAM00435 ANAM00436 ANAM00437 ANAK00335 ANAK00336 ANAK00654 ANAK00655 ANAK00656 ANAL01256 ANAL01257 ANAK00402 ANAK00403 ANAK00404 ANAK00405 ANAK00406 ANAK00407 ANAK00408 ANAK00590 ANAM00150 ANAM00151 ANAM00152 ANAM00153 ANAM00154 ANAM00202 ANAM00203 ANAM00204 ANAM00205 ANAM00225 ANAM00226 ANAM00474 ANAM00475 ANAM00476 ANAM00477 ANAM00478 ANAM00479 ANAM00480 ANAM00481 ANAM00482 ANAM00483 ANAJ00114 ANAK00216 ANAK00766 ANAK00767 ANAL01152 ANAL01153 ANAL01154 ANAL01155 ANAL01156 ANAL01157 ANAL01158 ANAL01159 ANAL01160 ANAL01161 ANAL01162 ANAL01163 ANAL01164 ANAL01165 ANAL01166 ANAL01167 ANAL01168 ANAL01169 ANAL01170 ANAL01171 ANAL01172 ANAL01263 ANAL01264 ANAM00103 ANAM00104 ANAM00105 ANAM00106 ANAM00107 ANAM00108 ANAM00354 ANAM00355 ANAM00356 ANAJ00117 ANAJ00118 ANAK00211 ANAK00212 ANAK00423 ANAK00576 ANAK00577 ANAK00578 ANAL00276 ANAL00277 ANAL00714 ANAL01392 ANAL01393 ANAJ00103 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 ANAL00533 ANAL00547 ANAL00548 ANAL00549 ANAL00550 ANAL00553 ANAL00554 ANAL00555 ANAL00556 ANAL00557 ANAL00558 ANAL00565 ANAL01313 ANAL01314 ANAL01315 ANAL01316 ANAL01317 ANAL01318 ANAL01319 ANAL01320 ANAK00150 ANAK00151 ANAK00217 ANAK00218 ANAK00219 ANAK00220 ANAL00103 ANAL00111 ANAL00112 ANAL00113 ANAL00114 ANAL01460 ANAL00904 ANAL00905 ANAK00504 ANAK00505 ANAK00235 ANAK00348 ANAK00349 ANAK00350 ANAK00351 ANAK00352 ANAK00353 ANAL00374 ANAL00375 ANAL00376 ANAL00402 ANAL00403 ANAL00546 ANAL01280 ANAL01281 ANAL01282 ANAL01283 ANAL01284 ANAL01285 ANAL01286 ANAL01330 ANAL01331 ANAL01332 ANAL01333 ANAL01334 ANAL01335 ANAK00424 ANAL01174 ANAL01175 ANAL01176 ANAL01177 ANAL01178 ANAL01179 ANAL01311 ANAK00221 ANAK00222 ANAL00267 ANAL00401 ANAL01370 ANAL00652 ANAL00653 ANAL01180 ANAL01181 ANAL01182 ANAL01309 ANAL01373 ANAL01549 ANAL01550 ANAM00216 ANAM00217 ANAM00254 ANAM00255 ANAM00256 ANAM00257 ANAM00258 ANAM00259 ANAM00260 ANAM00261 ANAM00262 ANAM00279 ANAM00280 ANAM00347 ANAM00348 ANAM00349 ANAM00364 ANAM00365 ANAM00366 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 ANAL00740 ANAL00741 ANAL00742 ANAL00743 ANAL00744 ANAL00745 ANAL01260 ANAL01261 ANAL01262 ANAL01029 ANAJ00252 ANAK00591 ANAK00592 ANAK00593 ANAK00594 ANAK00603 ANAK00604 ANAK00605 ANAK00606 ANAK00607 ANAK00608 ANAK00609 ANAK00610 ANAK00611 ANAK00612 ANAK00613 ANAK00614 ANAK00768 ANAK00769 ANAK00770 ANAK00793 ANAK00794 ANAK00795 ANAK00796 ANAK00797 ANAL00637 ANAL00729 ANAL00730 ANAL00731 ANAL00732 ANAL00733 ANAL00734 ANAL01548 ANAM00375 ANAM00376 ANAK00161 ANAL00458 ANAL01130 ANAL01396 ANAM00281 ANAM00422 ANAJ00119 ANAL00906 ANAL01310 ANAL01417 ANAM00357 ANAM00415 ANAK00251 ANAK00252 ANAJ00191 ANAJ00194 ANAK00142 ANAK00143 ANAK00144 ANAK00145 ANAK00589 ANAK00891 ANAK00892 ANAL00159 ANAL00183 ANAL00185 ANAL00186 ANAL00187 ANAL00502 ANAL01094 ANAJ00262 ANAJ00263 ANAK00147 ANAK00148 ANAK00204 ANAK00205 ANAK00206 ANAK00344 ANAK00354 ANAK00355 ANAK00356 ANAK00378 ANAK00379 ANAK00493 ANAK00494 ANAK00515 ANAK00516 ANAK00517 ANAK00518 ANAK00519 ANAK00520 ANAK00521 ANAK00522 ANAK00523 ANAK00524 ANAK00525 ANAK00574 ANAK00595 ANAK00596 ANAK00597 ANAK00744 ANAK00745 ANAK00746 ANAK00747 ANAL00104 ANAL00110 ANAL00115 ANAL00118 ANAL00119 ANAL00120 ANAL00160 ANAL00161 ANAL00239 ANAL00240 ANAL00245 ANAL00413 ANAL00414 ANAL00415 ANAL00419 ANAL00459 ANAL00460 ANAL00560 ANAL00561 ANAL00562 ANAL00563 ANAL00564 ANAL00566 ANAL00567 ANAL00568 ANAL00569 ANAL00570 ANAL00571 ANAL00572 ANAL00587 ANAL00588 ANAL00667 ANAL00668 ANAL00758 ANAL00759 ANAL00760 ANAL00761 ANAL00762 ANAL00770 ANAL00771 ANAL00793 ANAL00794 ANAL00795 ANAL00853 ANAL00854 ANAL00855 ANAL00856 ANAL00857 ANAL00865 ANAL01030 ANAL01031 ANAL01032 ANAL01033 ANAL01034 ANAL01035 ANAL01100 ANAL01101 ANAL01102 ANAL01103 ANAL01104 ANAL01105 ANAL01106 ANAL01183 ANAL01312 ANAL01342 ANAL01343 ANAL01344 ANAL01539 ANAL01540 ANAL01544 ANAL01545 ANAL01546 ANAL01547 ANAM00156 ANAM00157 ANAM00178 ANAM00179 ANAM00180 ANAM00181 ANAM00182 ANAM00183 ANAM00184 ANAM00185 ANAM00186 ANAM00213 ANAM00214 ANAM00215 ANAM00218 ANAM00337 ANAM00338 ANAM00350 ANAM00416 ANAM00417 ANAM00418 ANAM00419 ANAM00420 ANAM00459 ANAM00460 ANAM00461 ANAM00462 ANAJ00116 ANAJ00122 ANAJ00192 ANAJ00193 ANAJ00207 ANAK00149 ANAK00237 ANAK00678 ANAK00679 ANAL00249 ANAL00268 ANAL00298 ANAL00310 ANAL00420 ANAL00421 ANAL00425 ANAL00457 ANAL00503 ANAL00504 ANAL00505 ANAL00506 ANAL00507 ANAL00627 ANAL00628 ANAL00661 ANAL01265 ANAK00386 ANAK00669 ANAK00670 ANAK00671 ANAK00672 ANAK00673 ANAK00674 ANAK00675 ANAK00676 ANAK00677 ANAK00680 ANAK00690 ANAK00691 ANAK00692 ANAK00693 ANAK00694 ANAK00695 ANAK00696 ANAK00697 ANAK00698 ANAK00699 ANAK00700 ANAK00701 ANAL01380 ANAL01381 ANAM00149 ANAJ00115 ANAK00653 ANAK00716 ANAL00705 ANAL00706 ANAL00707 ANAL00708 ANAL00709 ANAL00710 ANAL00711 ANAL00713 ANAL00722 ANAL00723 ANAL00724 ANAL00725 ANAL00726 ANAL00727 ANAL00728 ANAL00735 ANAL00736 ANAL00737 ANAL00738 ANAL00739 ANAL00749 ANAL00750 ANAL00751 ANAL00752 ANAL00753 ANAL00754 ANAL00755 ANAL00756 ANAL00757 ANAL00769 ANAL00776 ANAL00777 ANAL00778 ANAL00779 ANAL00780 ANAL00781 ANAL00782 ANAL00783 ANAL00784 ANAL00785 ANAL00786 ANAL00787 ANAL00788 ANAL00789 ANAL00790 ANAL00791 ANAL00792 ANAL01038 ANAL01039 ANAL01040 ANAL01041 ANAL01042 ANAL01043 ANAL01044 ANAL01045 ANAL01046 ANAL01047 ANAL01048 ANAL01049 ANAL01050 ANAL01071 ANAL01072 ANAL01073 ANAL01074 ANAL01075 ANAL01076 ANAL01077 ANAL01078 ANAL01079 ANAL01080 ANAL01081 ANAL01082 ANAL01083 ANAL01084 ANAL01085 ANAL01086 ANAL01087 ANAL01088 ANAL01089 ANAL01090 ANAL01091 ANAL01092 ANAL01093 ANAL01107 ANAL01108 ANAL01109 ANAL01259 ANAL01541 ANAL01542 ANAL01543 ANAM00315 ANAM00316 ANAM00317 ANAM00318 ANAM00319 ANAM00320 ANAM00321 ANAM00322 ANAM00323 ANAM00324 ANAM00325 ANAM00326 ANAM00327 ANAM00328 ANAM00329 ANAM00330 ANAM00331 ANAM00332 ANAM00333 ANAM00334 ANAM00335 ANAM00336 ANAK00267 ANAK00650 ANAK00651 ANAK00652 ANAK00911 ANAK00912 ANAL00360 ANAL00850 ANAL00851 ANAL00852 ANAL01459 ANAL01484 ANAL01485 ANAJ00123 ANAL00198 ANAL00648 ANAJ00131 ANAJ00132 ANAJ00133 ANAJ00138 ANAJ00139 ANAJ00140 ANAJ00144 ANAJ00148 ANAJ00149 ANAJ00150 ANAJ00151 ANAJ00152 ANAJ00153 ANAJ00154 ANAJ00155 ANAJ00156 ANAJ00157 ANAJ00158 ANAJ00159 ANAJ00160 ANAJ00161 ANAJ00162 ANAJ00163 ANAK00110 ANAK00111 ANAK00112 ANAK00113 ANAK00114 ANAK00115 ANAK00116 ANAK00223 ANAK00236 ANAK00684 ANAK00685 ANAK00686 ANAK00687 ANAK00688 ANAK00702 ANAL00169 ANAL00170 ANAL00171 ANAL00172 ANAL00173 ANAL00174 ANAL00175 ANAL00176 ANAL00177 ANAL00178 ANAL00179 ANAL00180 ANAL00181 ANAL00182 ANAL00184 ANAL00188 ANAL00189 ANAL00280 ANAL00281 ANAL00282 ANAL00283 ANAL00284 ANAL00285 ANAL00286 ANAL00287 ANAL00288 ANAL00289 ANAL00290 ANAL00291 ANAL00292 ANAL00293 ANAL00294 ANAL01036 ANAL01207 ANAL01208 ANAL01209 ANAL01210 ANAL01211 ANAL01212 ANAL01213 ANAL01289 ANAL01290 ANAL01291 ANAL01292 ANAL01293 ANAL01294 ANAL01295 ANAL01296 ANAL01297 ANAL01298 ANAL01299 ANAL01390 ANAL01391 ANAL01419 ANAL01420 ANAL01421 ANAL01422 ANAL01423 ANAL01424 ANAL01425 ANAL00127 ANAL00359 ANAL00442 ANAL00443 ANAK00122 ANAK00141 ANAK00329 ANAK00330 ANAK00331 ANAK00332 ANAK00333 ANAK00334 ANAK00342 ANAK00476 ANAK00477 ANAK00496 ANAK00497 ANAK00503 ANAK00624 ANAK00642 ANAK00757 ANAK00903 ANAK00904 ANAK00905 ANAK00921 ANAL00117 ANAL00199 ANAL00229 ANAL00230 ANAL00241 ANAL00242 ANAL00243 ANAL00379 ANAL00396 ANAL00399 ANAL00400 ANAL00584 ANAL00585 ANAL00747 ANAL00806 ANAL00807 ANAL00808 ANAL00809 ANAL00832 ANAL00833 ANAL00834 ANAL00876 ANAL00877 ANAL00878 ANAL00894 ANAL00895 ANAL00902 ANAL00903 ANAL01321 ANAL01322 ANAL01323 ANAL01324 ANAL01412 ANAL01413 ANAL01414 ANAL00531 ANAL00532 ANAL01095 ANAL01096 ANAL01097 ANAL01098 ANAM00155 ANAM00438 ANAJ00213 ANAJ00260 ANAJ00261 ANAK00343 ANAK00472 ANAK00579 ANAK00846 ANAL00126 ANAL00140 ANAL00141 ANAL00200 ANAL00201 ANAL00422 ANAL00423 ANAL00424 ANAL00680 ANAL00681 ANAL00682 ANAL00746 ANAL01204 ANAM00209 ANAM00210 ANAM00211 ANAM00212 ANAK00240 ANAK00253 ANAK00410 ANAK00411 ANAK00412 ANAK00413 ANAK00414 ANAK00415 ANAK00416 ANAK00417 ANAK00418 ANAK00419 ANAK00420 ANAK00421 ANAK00462 ANAK00481 ANAK00482 ANAK00483 ANAK00484 ANAK00485 ANAK00486 ANAK00487 ANAK00488 ANAK00489 ANAK00490 ANAK00491 ANAK00703 ANAK00704 ANAK00705 ANAK00706 ANAK00707 ANAK00708 ANAK00709 ANAL00264 ANAL00265 ANAL00266 ANAL00465 ANAL00466 ANAL00467 ANAL00468 ANAL00469 ANAL00470 ANAL00471 ANAL00472 ANAL00473 ANAL00474 ANAL00475 ANAL00476 ANAL00477 ANAL00478 ANAL00479 ANAL00534 ANAL00535 ANAL00536 ANAL00537 ANAL00538 ANAL00539 ANAL00540 ANAL00541 ANAL00542 ANAL00543 ANAL00544 ANAL00545 ANAL00615 ANAL00616 ANAL00617 ANAL00618 ANAL00619 ANAL00620 ANAL00621 ANAL00622 ANAL00721 ANAL00860 ANAL00861 ANAL00862 ANAL00863 ANAL00893 ANAM00147 ANAM00148 ANAM00351 ANAM00352 ANAM00353
• Recalling Firm/ Manufacturer: GE Healthcare; 9900 Innovation Drive; Mail Stop: RP2138; Wauwatosa WI 53226
• Manufacturer Reason for Recall: Unintended shut-down: The anesthesia machine may start shutting down without human intervention due to a faulty On/Standby Switch. Prior to shutdown, the system will issue an alarm and play a message that shutdown will occur in 8 seconds. The failure only affects the electrical portion of the switch. If the clinician does not intervene, the patient could experience hypoventilation leading to h
• FDA Determined Cause: Component design/selection
• Action: GE Healthcare contacted consignees via two "Urgent Medical device Correction" letters dated February 5, 2009 and March 10, 2009. The letters are addressed to 3 titles within the affected accounts; Healthcare Administrator/Risk Manger, Chief of Intensive Care and Director of Biomedical Engineering. The letters describes the Safety Issue, Affected Product details, Safety Instructions, Product Correction and Contact Information. The second letter dated March 10, 2009 includes 700 serial numbers that were missing from the first letter. The second letter was only mailed to the consignees of the additional 700 units.
• Quantity in Commerce: 3082
• Distribution: Worldwide distribution: USA, Canada, Mexico, YEMEN, VENEZUELA, UNITED KINGDOM, UNITED ARAB EMIRATES, UKRAINE, TUrKEY, TUNISIA, THAILAND, SYRIAN ARAB REPUBLIC, SWITZERLAND, SWEDEN, SPAIN, SOUTH AFRICA, SLOVENIA, SLOVAKIA, SINGAPORE, SERBIA, SAUDI ARABIA, RUSSIA, QATAR, PORTUGAL, POLAND, PERU, PANAMA, PAKISTAN, NORWAY, NEW ZEALAND, NETHERLANDS, MOROCCO, MALAYSIA, MACEDONIA, LITHUANIA, LIBYA, LEBANON, LATVIA, KUWAIT, KOREA, KENYA, JORDAN, JAPAN, ITALY, ISRAEL, IRELAND, INDIA, HUNGARY, HONG KONG, GREECE, GERMANY, FRANCE, FINLAND, ESTONIA, EGYPT, DENMARK, CZECH REPUBLIC, CROATIA, COLoMBIA, CHINA, CHILE, BRAZIL, BELGIUM, BAHRAIN, AUSTRIA, AUSTRALIA, ARGENTINA.
• 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 = BSZ and Original Applicant = DATEX-OHMEDA, INC.