Class 2 Device Recall GE DatexOhmeda Aisys CS2 Anesthesia System

• Date Initiated by Firm: February 17, 2016
• Create Date: April 13, 2016
• Recall Status: Terminated on September 04, 2018
• Recall Number: Z-1381-2016
• Recall Event ID: 73383
• 510(K)Number: K132530
• Product Classification: Gas-machine, anesthesia - Product Code BSZ
• Product: GE Healthcare, Aisys CS2 anesthesia..
• Code Information: APWU00723 APWU00724 APWU01057 APWU01058 APWU01059 APWU02682 APWU02683 APWU02684 APWU02685 APWU02686 APWU02687 APWU02688 APWU02689 APWU02690 APWU02691 APWU02692 APWU02693 APWU02694 APWU02695 APWU01240 APWU01241 APWU01242 APWU01243 APWU01244 APWU01785 APWU01827 APWU01988 APWU01989 APWU01990 APWU01991 APWU01992 APWU01993 APWU01994 APWU01995 APWU01996 APWU01997 APWU02708 APWT02996 APWT02384 APWT02254 APWT02255 APWT02256 APWT02257 APWT02258 APWT03126 APWT03127 APWT02326 APWU02707 APWT00391 APWT00392 APWT00393 APWT00394 APWT00395 APWU01576 APWU01577 APWU01578 APWU00363 APWU00364 APWU00365 APWU00366 APWT00898 APWT00899 APWT02417 APWV00144 APWU00707 APWU00708 APWU00709 APWU00710 APWU00711 APWU02287 APWU00190 APWU02166 APWU02167 APWU02168 APWU02169 APWU02170 APWU02171 APWU02172 APWU02316 APWU02317 APWU02318 APWU02319 APWU02320 APWU02321 APWU02322 APWT02043 APWT02044 APWT02045 APWT02046 APWT02047 APWT02048 APWT02049 APWT02050 APWT02051 APWT02052 APWU00712 APWT03125 APWT02250 APWT02251 APWU00505 APWU00506 APWU00507 APWT02328 APWT02329 APWT02330 APWT02331 APWT02332 APWU00474 APWU00475 APWU00476 APWU00477 APWU00478 APWU00479 APWT00589 APWT00590 APWT00591 APWT00592 APWT00593 APWT00603 APWT00977 APWT00978 APWU01486 APWU01487 APWU01488 APWU01489 APWU01490 APWU01491 APWU01492 APWU01493 APWU01494 APWU01495 APWT00561 APWT00562 APWU00611 APWU00612 APWU00613 APWU00614 APWU00145 APWU00146 APWU02163 APWU02164 APWU02165 APWU02051 APWU02052 APWU01825 APWU01909 APWU01599 APWU01600 APWU01601 APWU01602 APWU02017 APWU02018 APWU02019 APWU02020 APWT02407 APWT02408 APWT02409 APWU02576 APWT02385 APWU02237 APWU02648 APWU00297 APWU01054 APWU01055 APWU01056 APWU01608 APWU01609 APWU01610 APWU01611 APWU01612 APWU01613 APWU01614 APWU01615 APWU02066 APWU02067 APWT02750 APWT02746 APWT02747 APWT02748 APWT02749 APWT02751 APWT02752 APWT02851 APWT02852 APWT02853 APWT02854 APWT02855 APWT02856 APWT02857 APWT02858 APWU00576 APWU00579 APWU00580 APWU00581 APWU00582 APWU00583 APWU00584 APWU00585 APWU00586 APWU00587 APWU00588 APWU00589 APWU00590 APWU00591 APWU00592 APWU00593 APWU00594 APWU00595 APWU00596 APWU00597 APWU00598 APWU00599 APWU00600 APWU00601 APWU00602 APWU00603 APWU00728 APWU00729 APWU00730 APWU00751 APWU00752 APWU00753 APWU00754 APWU00755 5404700 APWU00564 APWU00565 APWU00566 APWU00604 APWU00605 APWU00606 APWU02070 APWT00553 APWT00554 APWT00555 APWT00556 APWT00557 APWT00558 APWT00559 APWT00560 APWU00567 APWU01595 APWU02326 APWU01359 APWU01949 APWT02705 APWT02066 APWT02067 APWT02068 APWT02069 APWT02070 APWT02071 APWT02072 APWT02073 APWT02074 APWT02075 APWT02076 APWT02077 APWT02078 APWT02079 APWT02080 APWT02081 APWT02082 APWT02083 APWT02084 APWT02085 APWT02086 APWT02087 APWT02088 APWT02089 APWT02090 APWT02091 APWT02092 APWT02093 APWT02094 APWT02095 APWT02096 APWT02097 APWT02098 APWT02099 APWT02100 APWT02101 APWT02149 APWT02150 APWU02421 APWU02422 APWU02423 APWU02424 APWT02418 APWU02110 APWU02111 APWU00713 APWU01410 APWU01411 APWU01412 APWU00176 APWU00177 APWU00178 APWU02327 APWU02328 APWU00767 APWU00768 APWU00769 APWT02696 APWT02697 APWU01131 APWU01132 APWU01133 APWU00141 APWU00142 APWU02223 APWU02224 APWT02639 APWT02640 APWT02641 APWT02642 APWT02643 APWT02644 APWT02645 APWT02646 APWT03004 APWT03005 APWT03006 APWT03007 APWT03008 APWT03009 APWT03010 APWT03011 APWT03012 APWU02108 APWU00293 APWT02305 APWT02308 APWT02595 APWT02596 APWT02597 APWT02598 APWT02599 APWT02600 APWT02601 APWT02602 APWT02603 APWT02604 APWT02605 APWT02606 APWT02607 APWT02608 APWT02609 APWT02610 APWT02611 APWT02612 APWT02613 APWT02614 APWT02615 APWT02616 APWT02617 APWT02618 APWT02619 APWT02620 APWT02621 APWT02622 APWT02623 APWT02624 APWT02625 APWT02626 APWT02627 APWT02628 APWT02629 APWT03029 APWS00103 APWT02663 APWU01340 APWU01341 APWU01342 APWU01343 APWU01344 APWT02245 APWU00260 APWU01616 APWU01617 APWU01618 APWU01619 APWU01620 APWU01621 APWU01622 APWU01623 APWT00594 APWT00796 APWT00797 APWT00798 APWT00799 APWT00800 APWT00801 5400770 APWU01998 APWT00238 APWT00242 APWT00791 APWT02997 APWT02998 APWT02999 APWT03000 APWT03001 APWT03002 APWT03003 APWU02485 APWU02505 APWU02506 APWT00246 APWU01699 APWU01700 APWU01701 APWU01702 APWU01703 APWU01704 APWU01705 APWU01706 APWU01707 APWU01708 APWU01709 APWU01710 APWU02635 APWU02636 APWU02637 APWU02638 APWU02639 APWU02640 APWU02641 APWU02642 APWU02643 APWU02644 APWU02645 APWU02696 APWU02697 APWU02698 APWU02699 APWU02700 APWU02701 APWT00532 APWT02333 APWT02334 APWT02335 APWT02336 APWT02337 APWT02338 APWT02339 APWT02340 APWT02341 APWT00362 APWT00363 APWT03056 APWT03057 APWT00245 APWT00790 APWT02194 APWT00236 APWT00240 APWT00244 APWT02191 APWT02848 APWT02849 APWU01652 APWU01653 APWU01654 APWU01655 APWU01897 APWU02379 APWU02381 APWU01096 APWU01097 APWU01098 APWU01099 APWU01100 APWU01101 APWU01102 APWU01103 APWU01104 APWU01105 APWU01106 APWU01107 APWU01108 APWU01109 APWU01496 APWU01497 APWU01498 APWU01499 APWU01500 APWU01501 APWU01502 APWU01503 APWU01504 APWU01505 APWU01736 APWU01737 APWT00320 APWT00341 APWT00342 APWT00343 APWT00344 APWT00375 APWT00376 APWU01579 APWU01580 APWU01581 APWU01582 APWU00864 APWU00865 APWU00866 APWU00867 APWU00868 APWU00869 APWU00870 APWU00871 APWU01149 APWU01150 APWV00102 APWV00103 APWT00239 APWU00607 APWU00608 APWU00609 APWU00610 APWU02176 APWU01910 APWU00913 APWU01265 APWU01266 APWT02053 APWU01911 APWU01912 APWU01913 APWU01914 APWU00168 APWU00169 APWU00170 APWU00171 APWU02723 APWT00891 APWT00892 APWT02312 APWT02317 APWT02318 APWT02320 APWT02321 APWU01922 APWU01923 APWU01929 APWU01930 APWU01931 APWU01932 APWU01933 APWU01934 APWU01935 APWU01936 APWU01937 APWU01938 APWT02700 APWT02701 APWT02702 APWT02703 APWU02392 APWU02393 APWU02394 APWU02395 APWU02400 APWU02414 APWU02415 APWU02416 APWU02417 APWU02653 APWU02654 APWU02655 APWU02656 APWU02657 APWU02658 APWU02659 APWU02660 APWU02661 APWU02662 APWU02663 APWU02664 APWU02665 APWU02666 APWU02667 APWU02668 APWU02669 APWU02670 APWU02671 APWU02672 APWU01422 APWU00764 APWU00765 APWU00766 APWU00889 APWU02249 APWU02250 APWU02632 APWU02061 APWT00202 APWT00203 APWT00204 APWT03065 APWT03066 APWT03067 APWT03068 APWT03069 APWT03070 APWT03071 APWT03072 APWT03073 APWT03074 APWT03075 APWT03076 APWT03077 APWT03078 APWU01443 APWU01444 APWU01445 APWU01446 APWU01447 APWU01448 APWU01449 APWU01450 APWU01451 APWU01452 APWU01774 APWU01775 APWT02859 APWT02860 APWT02861 APWT02862 APWT02863 APWT02864 APWT02865 APWT02866 APWT02867 APWT02868 APWT03030 APWT03031 APWT03032 APWT03033 APWT03034 APWT03035 APWT03036 APWT03037 APWT03038 APWT03039 APWT03040 APWT03041 APWT03042 APWT03043 APWT03044 APWT03045 APWT03046 APWT03047 APWT03048 APWT03049 APWT03050 APWT03051 APWT03052 APWT03053 APWT03054 APWT03055 APWT00256 APWT00257 APWT02568 APWU01095 APWU00725 APWU00726 APWU00727 APWU01245 APWT02298 APWT02299 APWT02300 APWT02301 APWT02302 APWT02303 APWT02304 APWU00241 APWU00242 APWU00243 APWU00244 APWU00245 APWT02539 APWU01788 APWU01789 APWU01790 APWU01791 APWU01246 APWU01247 APWU01248 APWU02577 APWU02578 APWU02579 APWU02580 APWU02581 APWU02582 APWU02583 APWU00486 APWU00487 APWU00575 APWU01267 APWT03059 APWT03060 APWT03061 APWT03062 APWT03063 APWT03064 APWU02724 APWU02725 APWU02726 APWU02727 APWU02728 APWU02729 APWU02730 APWU02731 APWU02649 APWU02650 APWT03174 APWT03175 APWU01383 APWU01384 APWT03079 APWT03080 APWT03081 APWT03082 APWT03083 APWT03084 APWT03085 APWT03086 APWT03087 APWT03088 APWT03089 APWT03090 APWT03091 APWT03092 APWT03093 APWT03094 APWT03095 APWT03096 APWT03097 APWT03098 APWT03099 APWT03100 APWT03101 APWT03102 APWT03103 APWT03104 APWT03105 APWT03106 APWT00144 APWT00145 APWT00146 APWT00147 APWT00148 APWT00149 APWT00150 APWT00151 APWT00152 APWT00153 APWT00154 APWT00155 APWT02200 APWT00575 APWT00576 APWT00577 APWT00578 APWT00611 APWT00612 APWT00613 APWT00614 APWT00615 APWT00616 APWT00617 APWT00618 APWT00619 APWT00620 APWT00621 APWT00622 APWT00623 APWT00624 APWT00625 APWT00626 APWT00627 APWT00628 APWT00629 APWT00630 APWT00903 APWT00904 APWT00905 APWT00906 APWT00907 APWT00908 APWT00909 APWU01632 APWU01633 APWU01634 APWU02702 APWU02703 APWU02704 APWU02705 APWU02706 APWU01665 APWU01666 APWU01667 APWU01668 APWU01669 APWU01670 APWU01671 APWU01672 APWU01673 APWU01674 APWU01675 APWU01684 APWU01685 APWU01686 APWU01687 APWU01688 APWU01689 APWU01690 APWU01691 APWU01692 APWU01693 APWU01694 APWU02197 APWT00267 APWT00268 APWT00269 APWT00270 APWT00271 APWT00272 APWT00273 APWT00274 APWT00275 APWT00305 APWT00306 APWT00307 APWT00308 APWT00309 APWT00310 APWT00311 APWT00312 APWT00313 APWT00314 APWT00315 APWT00316 APWT00317 APWT00318 APWT00319 APWU01540 APWU01541 APWU01542 APWU01543 APWU01544 APWU01545 APWU01546 APWU01547 APWU01548 APWU01549 APWU01550 APWU01551 APWU01552 APWU01553 APWU01554 APWU01555 APWU01556 APWU01557 APWU01558 APWU01559 APWU01560 APWU01561 APWU01562 APWU01563 APWU01564 APWU01565 APWU01566 APWU01567 APWU01568 APWU01569 APWU01570 APWU01641 APWT02813 APWT02814 APWT00450 APWT00451 APWT00452 APWT00453 APWT00454 APWT00455 APWT00456 APWT00457 APWT00458 APWT00459 APWT02869 APWT02870 APWT02901 APWT02902 APWT02903 APWT02904 APWT02905 APWT02906 APWT02907 APWT02908 APWT02909 APWT02910 APWT02911 APWT02912 APWT02913 APWT02914 APWT02915 APWT02916 APWT02917 APWT02918 APWT02919 APWT02920 APWT02921 APWT02922 APWT02923 APWT02924 APWU02647 APWU01114 APWU00937 APWU00938 APWU02053 APWU02054 APWU02055 APWU02056 APWU02057 APWU02058 APWU00540 APWU00541 APWU00542 APWU00543 APWU00621 APWU00622 APWU00623 APWU00624 APWU00625 APWU00626 APWU00627 APWU00628 APWU00629 APWU00630 APWU00631 APWU00632 APWU00633 APWU00634 APWU00635 APWU00636 APWU00637 APWU00638 APWU00639 APWU00640 APWU00641 APWU00642 APWU00643 APWU00644 APWU00645 APWU00646 APWU00647 APWU00648 APWU00649 APWU00650 APWU00651 APWU00652 APWU00653 APWU00654 APWU00655 APWU00656 APWU00657 APWU00658 APWU00659 APWU00660 APWU00661 APWU00662 APWU00663 APWU00664 APWU00665 APWU00666 APWU00667 APWU00668 APWU00669 APWU00670 APWU00671 APWU00672 APWU00673 APWU00674 APWU00675 APWU00676 APWU00677 APWU00678 APWT03013 APWT03014 APWT03015 APWT03016 APWT03017 APWT03018 APWT03019 APWT03020 APWT03021 APWT03022 APWT03023 APWT03024 APWT03025 APWT03026 APWT03027 APWT03028 APWT02246 APWT02247 APWV00138 APWV00139 APWU00573 APWU02068 APWU00250 APWU00252 APWU01345 APWT01007 APWT01008 APWS00175 APWS00176 APWS00177 APWS00178 APWS00179 APWS00180 APWS00181 APWS00182 APWS00183 APWS00184 APWS00185 APWS00186 APWS00187 APWS00188 APWU00274 APWU00275 APWU00276 APWU00277 APWU00278 APWU00279 APWU00280 APWU00281 APWU00282 APWU00283 APWU00284 APWU00285 APWU00286 APWU00287 APWU00288 APWU00289 APWU00290 APWU00291 APWU00292 APWU00106 APWU00107 APWU00108 APWU00109 APWU01360 APWU01361 APWU01362 APWU01363 APWU01364 APWU01365 APWU01366 APWU01367 APWU01368 APWU01369 APWU01370 APWU01088 APWU01089 APWU01090 APWU01346 APWU01347 APWU00114 APWU00485 APWU01426 APWU02589 APWU02590 APWU02591 APWU02592 APWU02593 APWU02594 APWU02595 APWU02596 APWU02597 APWU02598 APWU02297 APWU02298 APWU02299 APWU02300 APWU02301 APWU02302 APWU02303 APWU02304 APWT02419 APWU01794 APWU01795 APWU01796 APWU01826 APWU01348 APWU01349 APWU01350 APWU01351 APWU01352 APWU01353 APWU01354 APWU01355 APWU01356 APWU01357 APWU01358 APWU01898 APWU01899 APWU01900 APWU01901 APWU01902 APWU01903 APWU01296 APWU01297 APWU01298 APWU01299 APWU01300 APWU01301 APWU01302 APWU01303 APWU01304 APWU01305 APWU01306 APWU01307 APWU01308 APWU01309 APWU01310 APWU01311 APWU01312 APWU01313 APWU01314 APWU01315 APWU01316 APWU01317 APWU01318 APWU01319 APWU01320 APWU01321 APWU01322 APWU01323 APWU01324 APWU01325 APWU01326 APWU01327 APWU01328 APWU01329 APWU01330 APWU01331 APWU01332 APWU01333 APWU01334 APWU01335 APWU01336 APWU01337 APWU01338 APWT02540 APWT02541 APWT02542 APWT02543 APWT00588 APWT02664 APWT02666 APWT02667 APWT02669 APWT02670 APWT02671 APWT02672 APWT00247 APWT00793 APWT02665 APWT02668 APWU02175 APWU00208 APWU00529 APWU00530 APWU00531 APWU00532 APWU00533 APWT02892 APWU01083 APWT00969 APWT00970 APWT00971 APWT00972 APWT00973 APWT00974 APWT00975 APWT00976 APWT02535 APWT00794 APWT00985 APWT00986 APWT00987 APWT00988 APWT00989 APWT00990 APWV00114 APWV00115 APWV00116 APWV00117 APWV00118 APWV00119 APWV00120 APWV00121 APWV00122 APWT00961 APWT00962 APWT00963 APWT00964 APWT00965 APWT00966 APWT00967 APWU01155 APWU01156 APWU01196 APWU01197 APWU01198 APWU01199 APWU01200 APWU01201 APWU01202 APWU01203 APWU01204 APWU01205 APWT01037 APWU00756 APWU00757 APWU00758 APWU00759 APWU00760 APWU00761 APWU00762 APWU00763 APWU01161 APWU01162 APWU01163 APWU01249 APWU02115 APWU02116 APWU02117 APWU02118 APWU02119 APWU02120 APWU02121 APWU02122 APWU02123 APWU02124 APWU02125 APWU02126 APWU02127 APWU02128 APWU02129 APWU02130 APWU02131 APWU02132 APWU02133 APWU02134 APWU02135 APWU02136 APWU02137 APWU02138 APWU02139 APWU02140 APWU02141 APWU02142 APWU02143 APWU01681 APWU01682 APWU01683 APWT00604 APWT00605 APWT00606 APWT00607 APWU01924 APWU01925 APWU01926 APWU01927 APWU02104 APWU01168 APWU01169 APWU01170 APWU01171 APWU01172 APWU01173 APWU01174 APWU01175 APWU01176 APWU01177 APWU01178 APWU01179 APWU01180 APWU01181 APWU01182 APWU01183 APWU01184 APWU01185 APWU01186 APWU01187 APWU01188 APWU01189 APWU01190 APWU00534 APWU00535 APWU00536 APWU00537 APWU01939 APWU01940 APWU01941 APWU01942 APWU01943 APWU01781 APWT02884 APWT02885 APWT02886 APWT02887 APWT02888 APWT02889 APWT02890 APWT02891 APWU01782 APWU01783 APWU02105 APWU02106 APWU02107 APWU01571 APWU01572 APWU01573 APWU01574 APWU01575 APWU01584 APWU01585 APWU01586 APWU01587 APWU01885 APWU01886 APWU02177 APWU02178 APWU02179 APWU02180 APWT02011 APWU00121 APWU01676 APWU02389 APWU02390 APWU02391 APWU01828 APWU01829 APWT00250 APWU00509 APWU00510 APWU00511 APWT02517 APWT02518 APWT02519 APWT02520 APWT02521 APWU00568 APWU00569 APWU00570 APWU00571 APWU00572 APWT00787 APWT00788 APWT02504 APWT02505 APWU00577 APWU00578 APWT02437 APWU00512 APWT02253 APWT02192 APWT02778 APWT02779 APWT02780 APWT02781 APWT02782 APWT02783 APWT02784 APWT02785 APWT02786 APWT02787 APWT02788 APWT02789 APWT03128 APWT03129 APWT00243 APWU01157 APWU01158 APWU01159 APWU01160 APWU01418 APWT00253 APWT00254 APWT02722 APWT02723 APWT02724 APWT02410 APWT02411 APWT02412 APWT02413 APWT02414 APWT02415 APWU01797 APWU01798 APWT03130 APWT03131 APWT03132 APWT03133 APWT03134 APWT03135 APWU02709 APWU02710 APWU02711 APWU02712 APWU02713 APWU02714 APWU02715 APWU02716 APWU01638 APWU01639 APWU01640 APWT02406 APWT02704 APWU01520 APWU01521 APWU01522 APWU01523 APWU00574 APWU01191 APWU01192 APWU01529 APWU01999 APWU02000 APWU02001 APWU02002 APWU02003 APWU02004 APWU02005 APWU02006 APWU02007 APWU02008 APWU02009 APWU02010 APWU02011 APWU02012 APWU02013 APWU02014 APWU02015 APWU02584 APWT00817 APWT00818 APWT00819 APWT00820 APWT02189 APWU01624 APWU01625 APWU01626 APWU01627 APWU01628 APWU01629 APWU01630 APWU01631 APWU02064 APWU02065 APWU02633 APWU02634 APWT00821 APWT00822 APWT00823 APWT00824 APWT00825 APWT00826 APWT00827 APWT00828 APWT00829 APWT00830 APWT00831 APWT00832 APWT00833 APWT00834 APWT00835 APWT00836 APWU01421 APWU00149 APWU00150 APWU00151 APWU00152 APWU00153 APWU00154 APWU00155 APWU00156 APWU00157 APWT00472 APWT00473 APWT00597 APWT00598 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5367002-1 5376729-1 5376729-2 5376729-3 5388059-1 5388059-2 5377707-1 5330734-1 5330734-2 5375042-1 5375042-2 5375042-3 5375042-4 5378701-1 5378701-2 5378701-3 5373220-1 5373220-2 5373220-3 5373220-4 5373220-5 5373220-6 5378963-1 5394512-1 5372155-1 5372155-2 5372155-3 6504252-1 5367773-1 5367773-2 5367773-3 5367773-4 5353419-3 5353419-4 5353420-2 5353421-1 5371113-1 5371113-2 5371113-3 5371113-4 5371113-5 5365353-4 5365353-5 5365354-3 5365355-2 5365356-1 6505037-1 5353403-1 5353403-2 5353403-3 5353403-4 5353403-5 5353403-6 5379292-1 5379292-2 5379292-3 5379292-4 5379292-5 5350814-1 5371747-1 ANAK00930 ANAP00606 ANAP00609 11342168 5384379-1 5384379-2 5384379-3 5384379-4 5384379-5 5384379-6 5384379-7 5384379-8 11341897 5378034-1 5378034-2 5367586-1 5367586-2 5390285-1 5376732-1 5376732-2 5376732-3 5379286-1 5379286-2 5379286-3 5350424-1 5350424-2 5350424-3 5350424-4 5390390-1 5390390-2 5370659-1 5368095-1 5368095-2 5368095-3 5368095-4 5368095-5 5330740-1 5330740-2 6511813-1 5371854-1 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• Recalling Firm/ Manufacturer: GE Medical Systems, LLC; 3000 N Grandview Blvd; Waukesha WI 53188-1615
• For Additional Information Contact: GE Healthcare Service; 800-437-1171
• Manufacturer Reason for Recall: GE Healthcare has recently become aware of a potential safety issue involving a momentary, self-correcting anesthetic agent bolus when using 21% oxygen on all Aisys CS2 and upgraded Aisys anesthesia devices.
• FDA Determined Cause: Nonconforming Material/Component
• Action: Consignees were sent on 2/17/2016 a GE Healthcare "Urgent Medical Device Correction" letter GEHC Ref# 34075 dated February 17, 2016.The letter was addressed to Chief of Anesthesia, Director of Biomedical / Clinical Engineering, and Health Care Administrator / Risk Manager. The letter described the Safety Issue, Safety Instructions, Affected Product Details, Product Correction and Contact Information. For questions contact GE Healthcare Service at 1-800-437-1171 or your local Service Representative.
• Quantity in Commerce: 5496
• Distribution: US: AL, AZ, AR, CA, CO, DC, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MO, NE, NV, NJ, NY, NC, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI. OUS: ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, BERMUDA, BOLIVIA, BRAZIL, CANDA, CHILE, CHINA, COLOMBIA, CROATIA, CR¿CHE REPUBLIC, DENMARK, ESTONIA, FINLAND, FRANCE, GERMANY,GREECE, HELSINKI, HONG KONG, HUNGARIA, ICELAND, INDIA, IRAQ, IRELAND, ITA LY, JAPAN, JORDAN, KAZAKHSTAN, KOREA, KUWAIT, MALAYSIA, MEXICO, MOLDOVA, MOROCCO, NETHERLANDS, NEW CALEDONIA, NEW ZEALAND, NORWAY, PERU, POLAND, PORTUGAL QATAR, REUNION, ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SWEDEN SWITZERLAND, TAIWAN, TANZANIA, THAILAND, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM,URUGUAY, VIETNAM.
• 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.