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U.S. Department of Health and Human Services

Class 2 Device Recall Tec 850 ISO

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 Class 2 Device Recall Tec 850 ISOsee related information
Date Initiated by FirmNovember 18, 2024
Date PostedJanuary 07, 2025
Recall Status1 Open3, Classified
Recall NumberZ-0817-2025
Recall Event ID 95855
510(K)NumberK172702 
Product Classification Vaporizer, anesthesia, non-heated - Product Code CAD
ProductTec 850 ISO Anesthesia Vaporizer, Reference Number 1177-9850-ISO
Code Information GTIN: 00840682124751; Serial Numbers: SQAC00742 SQAC00743 SQAC00749 SQAC01478 SQAC01480 SQAC01482 SQAC01483 SQAC01484 SQAC01485 SQAC01486 SQAC01100 SQAD01228 SQAC00649 SQAD00303 SQAD01180 SQAD01191 SQAD00165 SQAD00170 SQAC00944 SQAD00135 SQAD00148 SQAD01165 SQAC01012 SQAC01014 SQAD00107 SQAD00758 SQAD00767 SQAD00790 SQAC01172 SQAC00827 SQAC00835 SQAD00497 SQAC01111 SQAC01160 SQAC01180 SQAC01182 SQAC01183 SQAC00902 SQAC00904 SQAD00674 SQAD00677 SQAC00976 SQAD01129 SQAD01143 SQAD00045 SQAD00047 SQAD00181 SQAD00187 SQAC01376 SQAC01379 SQAC00666 SQAC00668 SQAC01019 SQAD00161 SQAD00168 SQAD00169 SQAD00178 SQAD00179 SQAC00908 SQAC00584 SQAC00876 SQAC00841 SQAD01178 SQAC00789 SQAD00120 SQAD00141 SQAD00482 SQAD00517 SQAD00519 SQAD00520 SQAD00521 SQAD00522 SQAD00530 SQAD00864 SQAD00866 SQAD00868 SQAD00869 SQAD00872 SQAD00874 SQAD00877 SQAD00878 SQAD00890 SQAD00891 SQAD00892 SQAD00895 SQAD00896 SQAD00897 SQAD00899 SQAD00905 SQAC01007 SQAD00787 SQAD00793 SQAD00810 SQAD00814 SQAC00967 SQAC00968 SQAC00971 SQAC00972 SQAC00662 SQAC00763 SQAC00688 SQAC00665 SQAC00759 SQAC01008 SQAC01371 SQAC01402 SQAD01171 SQAD01172 SQAD01179 SQAD01150 SQAD01158 SQAD01163 SQAC00973 SQAC00978 SQAD01067 SQAC01001 SQAD00722 SQAD00723 SQAD00725 SQAD00726 SQAD00727 SQAD00728 SQAD00729 SQAD00731 SQAD00733 SQAD00739 SQAC01363 SQAC01370 SQAC00708 SQAC01372 SQAD00902 SQAC00899 SQAC00905 SQAD00765 SQAD00766 SQAD00769 SQAD00771 SQAD00772 SQAD00773 SQAD00774 SQAD00776 SQAD00782 SQAC00999 SQAC01000 SQAC01003 SQAC01004 SQAC01017 SQAD00356 SQAC01383 SQAC00524 SQAC00986 SQAC01463 SQAC00698 SQAC01410 SQAD00249 SQAD00385 SQAC00639 SQAD00745 SQAD00954 SQAC00777 SQAD00732 SQAD00804 SQAD00806 SQAD00807 SQAD00809 SQAC01251 SQAC01322 SQAD00248 SQAD00250 SQAD00252 SQAD00254 SQAD00257 SQAD00312 SQAD00313 SQAD00315 SQAD00054 SQAD00055 SQAD00183 SQAD00185 SQAD00239 SQAD00241 SQAD00688 SQAD00186 SQAD00194 SQAC01236 SQAC00657 SQAC00781 SQAC00782 SQAC00783 SQAC00784 SQAC00788 SQAC00792 SQAD00652 SQAD00130 SQAC01431 SQAD01229 SQAD01235 SQAD01237 SQAD01239 SQAD00227 SQAD00230 SQAD00235 SQAD00236 SQAD01164 SQAC01413 SQAC01416 SQAC01425 SQAC00588 SQAC00602 SQAC00640 SQAC00677 SQAC00680 SQAC00683 SQAC00689 SQAC00699 SQAD00095 SQAC01235 SQAC01264 SQAD00792 SQAD00797 SQAD00504 SQAD00701 SQAD00818 SQAD01169 SQAD00691 SQAC00570 SQAC00572 SQAC00575 SQAD01176 SQAC01168 SQAC01011 SQAC01028 SQAC01029 SQAD00222 SQAD00242 SQAD00243 SQAD00244 SQAD00245 SQAD00299 SQAD00300 SQAD00301 SQAD00304 SQAD00306 SQAC01036 SQAC01041 SQAC01042 SQAC00667 SQAC00669 SQAC00670 SQAC00671 SQAC00762 SQAC01162 SQAC00635 SQAC00638 SQAC00748 SQAD00956 SQAC00878 SQAC00809 SQAC00810 SQAC00845 SQAC00896 SQAD01065 SQAD00805 SQAD00811 SQAC01156 SQAD00177 SQAD00180 SQAD00182 SQAD00963 SQAD00921 SQAD00922 SQAD00514 SQAD00560 SQAD00562 SQAC01242 SQAD00028 SQAD00033 SQAD00034 SQAD00035 SQAD00038 SQAD00039 SQAC01167 SQAC01252 SQAC01254 SQAC01255 SQAC01257 SQAD00311 SQAD00867 SQAD00875 SQAD00876 SQAD00879 SQAD00880 SQAD01100 SQAD01101 SQAD01108 SQAD01120 SQAD01177 SQAD01181 SQAC00663 SQAD00081 SQAD00082 SQAD00083 SQAD00084 SQAD00085 SQAD00086 SQAD00908 SQAD00931 SQAD00934 SQAD00171 SQAC00824 SQAD00069 SQAD00911 SQAD00903 SQAD00933 SQAD01230 SQAC01053 SQAC01065 SQAC01074 SQAC01082 SQAC01083 SQAC01087 SQAC01088 SQAC01090 SQAC01091 SQAC01092 SQAC01093 SQAD00696 SQAD00698 SQAC01209 SQAC01002 SQAD00046 SQAD00050 SQAD00052 SQAD00056 SQAD00707 SQAD00716 SQAD00719 SQAD00788 SQAD00708 SQAD00711 SQAD00712 SQAD00715 SQAD00803 SQAD01170 SQAD00799 SQAD00802 SQAC00775 SQAC00776 SQAC00522 SQAC00952 SQAD00328 SQAC00836 SQAC00887 SQAC00913 SQAC00914 SQAC00917 SQAC00919 SQAC00920 SQAC00921 SQAC00923 SQAC00924 SQAC00925 SQAC00974 SQAC01391 SQAC01396 SQAC00802 SQAC01109 SQAC01176 SQAC01177 SQAC00648 SQAC00652 SQAC00969 SQAC00980 SQAC00981 SQAC00982 SQAC00983 SQAC01193 SQAC01225 SQAC01374 SQAC01184 SQAC01185 SQAC01197 SQAC00975 SQAC01039 SQAD01167 SQAD00542 SQAD00548 SQAD00551 SQAD00555 SQAD00557 SQAD00559 SQAD00561 SQAD00764 SQAC01159 SQAC01179 SQAC01095 SQAD01236 SQAC00823 SQAC00825 SQAC00826 SQAC00828 SQAD00106 SQAD01217 SQAD00302 SQAC01084 SQAC01086 SQAC01097 SQAC00500 SQAD00724 SQAD00760 SQAD00763 SQAD00768 SQAD01131 SQAD00307 SQAC01206 SQAC01067 SQAC01077 SQAC01381 SQAC00521 SQAC00512 SQAD00693 SQAD00694 SQAD00695 SQAD00697 SQAC00501 SQAC00673 SQAC00697 SQAC00916 SQAC01355 SQAC01365 SQAD00689 SQAC01098 SQAC00883 SQAC01094 SQAC01452 SQAC01454 SQAC01472 SQAC01473 SQAC01475 SQAC01479 SQAC01481 SQAD01173 SQAD01160 SQAD01187 SQAD01189 SQAD01190 SQAD00702 SQAD00703 SQAC00502 SQAC00503 SQAC00505 SQAC00506 SQAD00985 SQAC00744 SQAC00576 SQAC00922 SQAC01267 SQAD00647 SQAD00990 SQAD00992 SQAD00997 SQAD01003 SQAD00354 SQAD00525 SQAD00526 SQAD00552 SQAC00794 SQAC00797 SQAC00798 SQAC00799 SQAC00801 SQAC00803 SQAC00805 SQAC00806 SQAC00807 SQAC00808 SQAD00937 SQAD00938 SQAD00941 SQAD00943 SQAD00944 SQAC00804 SQAC01018 SQAC01196 SQAC01005 SQAC01006 SQAD00851 SQAD00861 SQAD00882 SQAC01263 SQAC01265 SQAC01271 SQAC01272 SQAC01273 SQAC00494 SQAC00834 SQAC01030 SQAD00340 SQAD00344 SQAD00345 SQAD00348 SQAD00349 SQAD00546 SQAD00549 SQAD00553 SQAD00554 SQAD00567 SQAD00568 SQAD00571 SQAD00572 SQAD00578 SQAD00580 SQAD00624 SQAD00627 SQAD00630 SQAD00636 SQAD00638 SQAD00639 SQAD00641 SQAD00643 SQAD00646 SQAC00562 SQAC00573 SQAC00574 SQAC00817 SQAC00818 SQAC01221 SQAD00232 SQAD00233 SQAD00238 SQAD00812 SQAD00295 SQAD00297 SQAD00298 SQAD00308 SQAD00314 SQAC00897 SQAC00569 SQAC01166 SQAD00005 SQAC00495 SQAD00949 SQAC00903 SQAD00953 SQAD00909 SQAD00951 SQAC00839 SQAC00707 SQAD00346 SQAD00730 SQAD00734 SQAD00735 SQAD00737 SQAD00738 SQAC00596 SQAC00597 SQAC00598 SQAC00606 SQAC00628 SQAC00636 SQAC00561 SQAC00595 SQAC00583 SQAC00627 SQAC00560 SQAC00590 SQAC00599 SQAC00611 SQAC00613 SQAC00616 SQAC00617 SQAC00618 SQAC00620 SQAC00621 SQAC00623 SQAC00624 SQAC00625 SQAC00626 SQAC00630 SQAD00029 SQAD00037 SQAD00040 SQAD00041 SQAD00042 SQAD00043 SQAD00044 SQAD00049 SQAD00051 SQAD00053 SQAD00058 SQAD00060 SQAD00062 SQAD00063 SQAD00064 SQAD00067 SQAD00068 SQAD00072 SQAD00073 SQAD00074 SQAD00075 SQAD00076 SQAD00078 SQAD00079 SQAD00080 SQAD00128 SQAD00145 SQAD00146 SQAD00147 SQAD00149 SQAD00150 SQAD00151 SQAD00152 SQAD00153 SQAD00154 SQAD00155 SQAD00156 SQAD00157 SQAD00158 SQAD00159 SQAD00160 SQAD00162 SQAD00163 SQAD00164 SQAD00166 SQAD00167 SQAD00172 SQAD00173 SQAD00174 SQAD00175 SQAD00495 SQAD00500 SQAD00501 SQAD00502 SQAD00505 SQAD00506 SQAD00509 SQAD00511 SQAD00512 SQAD00513 SQAD00515 SQAD00516 SQAD00518 SQAD00528 SQAD00531 SQAD00532 SQAD00533 SQAD00534 SQAD00535 SQAD00536 SQAD00537 SQAD00539 SQAD00540 SQAD00541 SQAD01006 SQAC01364 SQAC01366 SQAC01460 SQAC01465 SQAC01471 SQAC01487 SQAC01488 SQAC01489 SQAD00350 SQAD00351 SQAD00352 SQAD00353 SQAD00472 SQAD00529 SQAD01068 SQAD01070 SQAD01072 SQAD01073 SQAD01075 SQAD01077 SQAD01085 SQAD01086 SQAD01087 SQAD01088 SQAC00651 SQAC00653 SQAC00681 SQAC00687 SQAC00695 SQAC00702 SQAC00703 SQAC00704 SQAC00705 SQAC00706 SQAC00709 SQAC00710 SQAC00711 SQAC00713 SQAC00715 SQAC00717 SQAC00718 SQAC00719 SQAC00720 SQAC00722 SQAC00723 SQAC00724 SQAC01085 SQAC01096 SQAC01101 SQAC01113 SQAC01116 SQAC01120 SQAC01122 SQAC01123 SQAC01124 SQAC01125 SQAC01126 SQAC01127 SQAC00614 SQAC00615 SQAC00622 SQAC00631 SQAC00589 SQAC00593 SQAC01316 SQAC01317 SQAC01324 SQAC01332 SQAC01333 SQAC01336 SQAC01337 SQAC01343 SQAC01347 SQAC01348 SQAC01350 SQAC01357 SQAC00563 SQAC00568 SQAC00619 SQAC00632 SQAC00813 SQAC01137 SQAC01139 SQAD00355 SQAD00357 SQAD00360 SQAD00362 SQAD00363 SQAD00499 SQAD00507 SQAD00508 SQAD00564 SQAD00566 SQAC00493 SQAC00498 SQAC00499 SQAC00525 SQAC00527 SQAC00534 SQAC00535 SQAC00536 SQAC00537 SQAC00949 SQAC00950 SQAC00955 SQAC00956 SQAC00957 SQAC00958 SQAC00963 SQAC00964 SQAC00965 SQAC00966 SQAD00105 SQAD00108 SQAD00109 SQAD00111 SQAD00112 SQAD00115 SQAD00125 SQAD00126 SQAD00131 SQAD00132 SQAD00133 SQAD00138 SQAD00721 SQAD00586 SQAD00589 SQAD00590 SQAD00591 SQAD00596 SQAC00682 SQAC00692 SQAC00693 SQAC00694 SQAC00728 SQAC00729 SQAC00731 SQAC00732 SQAC00733 SQAC00734 SQAC00735 SQAC00736 SQAC00737 SQAC00738 SQAC00740 SQAC00745 SQAC00746 SQAC00750 SQAC00752 SQAC00753 SQAD00099 SQAD00101 SQAD00103 SQAD00104 SQAD00258 SQAD00288 SQAD00343 SQAD00347 SQAD00633 SQAD00640 SQAD00642 SQAD00644 SQAD00986 SQAD00987 SQAD00988 SQAD00991 SQAD00994 SQAD00998 SQAD01000 SQAD01001 SQAD01002 SQAD01005 SQAD00490 SQAC01057 SQAD00395 SQAD00584 SQAD00585 SQAD00587 SQAD00595 SQAD00598 SQAD00599 SQAD00600 SQAD00601 SQAD00663 SQAD00664 SQAD00666 SQAD00667 SQAD00668 SQAD00669 SQAD00671 SQAD00749 SQAD00751 SQAD00756 SQAD00777 SQAD00778 SQAD00786 SQAD00789 SQAD00821 SQAD00822 SQAD00849 SQAD01103 SQAD01105 SQAD01166 SQAD01192 SQAC01059 SQAC01081 SQAC01174 SQAC01175 SQAC01386 SQAD00025 SQAD00026 SQAD00027 SQAD00030 SQAD00036 SQAC00643 SQAC00787 SQAC00793 SQAC00796 SQAC01187 SQAC01195 SQAC01384 SQAC01385 SQAC01390 SQAC01393 SQAC01398 SQAC01399 SQAC01401 SQAC01403 SQAC01405 SQAC01407 SQAC01414 SQAC01415 SQAC01417 SQAC01418 SQAC01419 SQAC01420 SQAC01423 SQAD00392 SQAD00393 SQAD00394 SQAD00396 SQAD00397 SQAD00398 SQAD00399 SQAD00400 SQAD00401 SQAD00402 SQAD00403 SQAD00547 SQAD00602 SQAD00603 SQAD00604 SQAD00605 SQAD00606 SQAD00610 SQAD00611 SQAD00612 SQAD00613 SQAD00614 SQAD00616 SQAD00617 SQAD00618 SQAD00621 SQAD00622 SQAD00623 SQAD00625 SQAD00626 SQAD00628 SQAD00629 SQAD00634 SQAD00648 SQAD00653 SQAD00654 SQAD00655 SQAD00656 SQAD00658 SQAD00660 SQAD00926 SQAD00939 SQAD00955 SQAD00957 SQAD00959 SQAD00960 SQAD00964 SQAD00965 SQAD00967 SQAD00968 SQAD00969 SQAD00970 SQAD00971 SQAD00972 SQAD00973 SQAD00974 SQAD00975 SQAD00977 SQAD00978 SQAD00979 SQAD00982 SQAD00983 SQAD00984 SQAD00919 SQAD00936 SQAD00940 SQAD00942 SQAD00946 SQAD00989 SQAD00995 SQAD01008 SQAD01010 SQAD01013 SQAC00540 SQAC00546 SQAC00548 SQAC00970 SQAC01009 SQAC01199 SQAC01201 SQAC01205 SQAC01207 SQAC01286 SQAC01289 SQAC01298 SQAC01299 SQAC01305 SQAC01310 SQAC01375 SQAC01380 SQAC01428 SQAC01429 SQAD00333 SQAD00335 SQAD00672 SQAD00675 SQAD00676 SQAD00678 SQAD00679 SQAD00681 SQAD00746 SQAD00770 SQAD00775 SQAD00779 SQAD00781 SQAD00783 SQAD00794 SQAD00795 SQAD00796 SQAD00798 SQAD00801 SQAD00901 SQAD00910 SQAD00914 SQAD00916 SQAD00920 SQAD00962 SQAD01004 SQAD01009 SQAD01011 SQAD01017 SQAD01019 SQAD01021 SQAD01022 SQAD01024 SQAD01025 SQAD01026 SQAD01027 SQAD01032 SQAD01035 SQAD00717 SQAC01240 SQAC01208 SQAC01212 SQAC01213 SQAD00289 SQAD00327 SQAD00330 SQAD00336 SQAD00337 SQAD00338 SQAD00339 SQAD00341 SQAD00342 SQAC01270 SQAC00497 SQAD01238 SQAD00906 SQAC00898 SQAD00850 SQAC00779 SQAD00915 SQAC01294 SQAD01149 SQAD01007 SQAD01126 SQAD01144 SQAD01148 SQAD01151 SQAD01155 SQAD01186 SQAD00491 SQAD00699 SQAC00303 SQAD00378 SQAC01262 SQAC01266 SQAC00892 SQAD00907 SQAD00848 SQAD00489 SQAD01140 SQAD01020 SQAC01287 SQAD00705 SQAC00725 SQAC00885 SQAC01314 SQAC01315 SQAC01321 SQAC01323 SQAC01327 SQAC01335 SQAD00224 SQAD00231 SQAD00543 SQAD00545 SQAD00563 SQAD00570 SQAD00574 SQAC00714 SQAC00893 SQAC00900 SQAC01200 SQAC00894 SQAC01013 SQAC01198 SQAC01409 SQAC01411 SQAD01182 SQAD00823 SQAC01136 SQAC01181 SQAD00619 SQAD00744 SQAD00817 SQAC01382 SQAD00993 SQAD00593 SQAC00515 SQAC00679 SQAC00686 SQAD00524 SQAD00550 SQAD00510 SQAD00556 SQAD00888 SQAD00893 SQAD00894 SQAD00900 SQAD00918 SQAD00924 SQAD00927 SQAD00928 SQAC01216 SQAC01219 SQAC01222 SQAC01243 SQAC01244 SQAC01280 SQAC01218 SQAC01230 SQAC01231 SQAC01275 SQAD00800 SQAC01268 SQAC01269 SQAC00600 SQAC00601 SQAC00604 SQAC00605 SQAC01145 SQAC01146 SQAC01147 SQAC01150 SQAC01152 SQAC01153 SQAC01154 SQAC01155 SQAC01164 SQAC01433 SQAD00503 SQAD00635 SQAD00637 SQAD00004 SQAD00006 SQAD00007 SQAD00012 SQAD00019 SQAD00020 SQAD00816 SQAC01329 SQAC01354 SQAC01436 SQAC01149 SQAC01151 SQAC01170 SQAD00865 SQAC00891 SQAD00815 SQAD00819 SQAD00820 SQAC00492 SQAC00496 SQAC01331 SQAC01388 SQAC01394 SQAC01325 SQAC01326 SQAC01328 SQAC01330 SQAC01491 SQAC01493 SQAD00102 SQAD00117 SQAD00118 SQAD00119 SQAD00122 SQAC01492 SQAC01498 SQAD00415 SQAD00418 SQAC01211 SQAC01296 SQAC00454 SQAC00853 SQAC00874 SQAD00121 SQAD00190 SQAD00192 SQAD00193 SQAD00195 SQAD00196 SQAD00214 SQAD00255 SQAD00256 SQAD00259 SQAD00260 SQAD00261 SQAD00262 SQAD00264 SQAD00265 SQAD00266 SQAD00286 SQAD00290 SQAD00310 SQAD00316 SQAD00317 SQAD00318 SQAD00319 SQAD00320 SQAD00321 SQAD00322 SQAD00323 SQAD00324 SQAD00325 SQAD00326 SQAD00329 SQAD00332 SQAD00364 SQAD00365 SQAD00366 SQAD00367 SQAD00368 SQAD00369 SQAD00370 SQAD00371 SQAD00372 SQAD00373 SQAD00620 SQAD00632 SQAD00645 SQAD00649 SQAD00650 SQAD00651 SQAD00657 SQAD00659 SQAC00767 SQAC00840 SQAC00846 SQAD00409 SQAC00240 SQAC00507 SQAC00514 SQAC00566 SQAC00567 SQAC01016 SQAC01020 SQAC01021 SQAC01024 SQAD00061 SQAD00065 SQAD00066 SQAD00070 SQAD00071 SQAD00077 SQAD00673 SQAC01340 SQAD00123 SQAC01022 SQAC01023 SQAC01025 SQAC01026 SQAC01027 SQAC01169 SQAC01311 SQAC01312 SQAC01313 SQAD00662 SQAD00670 SQAD00683 SQAD00684 SQAC01260 SQAD00251 SQAD01157 SQAD01162 SQAD00904 SQAD00947 SQAD01145 SQAD01207 SQAD00188 SQAC00571 SQAC00578 SQAC00582 SQAC00586 SQAC00591 SQAC00592 SQAC00594 SQAC00612 SQAC00685 SQAC00690 SQAC00700 SQAC00701 SQAC00712 SQAC00727 SQAC00730 SQAC00747 SQAC00751 SQAC00754 SQAC00755 SQAC00756 SQAC00757 SQAC00760 SQAC00761 SQAC00766 SQAC00772 SQAC00786 SQAC00800 SQAC00816 SQAC00829 SQAC00830 SQAC00831 SQAC00832 SQAC00833 SQAC00837 SQAC00838 SQAC00861 SQAC00863 SQAC00864 SQAC00865 SQAC00868 SQAC00869 SQAC00870 SQAC00871 SQAC01051 SQAC01068 SQAC01069 SQAD00184 SQAD00253 SQAD00267 SQAD00268 SQAD00269 SQAD00270 SQAD00271 SQAD00272 SQAD00273 SQAD00275 SQAD00276 SQAD00293 SQAD00294 SQAD00714 SQAD00718 SQAD00741 SQAD01107 SQAD01231 SQAD01232 SQAD01233 SQAD01240 SQAD01241 SQAD01247 SQAC01387 SQAC01392 SQAC01432 SQAC01437 SQAC01439 SQAC01440 SQAC01441 SQAC01442 SQAC01443 SQAC01444 SQAC00656 SQAC00658 SQAC00659 SQAC00660 SQAC00661 SQAC00664 SQAD00743 SQAD00748 SQAD00750 SQAD00752 SQAD00753 SQAD00755 SQAD00757 SQAD00759 SQAC01344 SQAC00815 SQAC00721 SQAD01128 SQAD01146 SQAD01147 SQAC00539 SQAC00607 SQAC00608 SQAC00609 SQAC00610 SQAC00647 SQAC00645 SQAC00646 SQAC00650 SQAD00680 SQAD01195 SQAC00518 SQAC00577 SQAC00579 SQAC00580 SQAC00629 SQAC00637 SQAC00716 SQAC00860 SQAC00886 SQAC00901 SQAC00906 SQAC00907 SQAC00915 SQAC01477 SQAD00225 SQAD00917 SQAD00791 SQAC00538 SQAC00541 SQAC00542 SQAC00543 SQAC00544 SQAC00545 SQAC00547 SQAC00549 SQAC00550 SQAC00551 SQAC00552 SQAC00553 SQAC00554 SQAC00555 SQAC00556 SQAC00557 SQAC00558 SQAC00559 SQAC00564 SQAC00565 SQAC00581 SQAC00585 SQAC00587 SQAC01339 SQAD00588 SQAD00631 SQAD00780 SQAD00785 SQAD00538 SQAD00948 SQAD00952 SQAC01189 SQAC01114 SQAC01121 SQAC01031 SQAC01034 SQAD00912 SQAD00913 SQAD00923 SQAD00929 SQAD00930 SQAD00935 SQAD00976 SQAD00980 SQAC01421 SQAD00483 SQAD00484 SQAD00494 SQAD00496 SQAD01216 SQAD01225 SQAC00504 SQAC00508 SQAC00866 SQAC00867 SQAC00872 SQAC00873 SQAC00877 SQAC00909 SQAC00910 SQAC00911 SQAC00912 SQAC00918 SQAC01010 SQAD00094 SQAD00229 SQAD00480 SQAD01012 SQAD00093 SQAC01297 SQAC00890 SQAC01099 SQAD00544 SQAD00685 SQAC00526 SQAC00528 SQAC01163 SQAC01171 SQAD00361 SQAC00519 SQAD00665 SQAC01241 SQAC01250 SQAC01256 SQAC01258 SQAC01261 SQAC00977 SQAC01040 SQAD00686 SQAD00692 SQAD00176 SQAD00274 SQAD00277 SQAD00278 SQAD00279 SQAD00280 SQAD00281 SQAD00282 SQAD00283 SQAD00284 SQAD00285 SQAD00287 SQAD00291 SQAD00292 SQAD00296 SQAC01035 SQAC01044 SQAC01045 SQAC01048 SQAD00709 SQAD00710 SQAC01128 SQAC01129 SQAC01130 SQAC01131 SQAC01132 SQAC01135 SQAC01202 SQAC01204 SQAD00087 SQAD00088 SQAD00089 SQAD00090 SQAD00091 SQAD00092 SQAD00096 SQAD00097 SQAD00098 SQAD00100 SQAD00110 SQAD00113 SQAD00114 SQAD00661 SQAD00898 SQAD01133 SQAD01152 SQAD01153 SQAD01154 SQAD01156 SQAD01159 SQAD01161 SQAD01174 SQAD01196 SQAD01201 SQAD01202 SQAD01204 SQAD01208 SQAD01209 SQAD01210 SQAD01257 SQAC01408 SQAD00961 SQAC00634 SQAD00687 SQAD00690 SQAC01194 SQAD00305 SQAD00309 SQAC00773 SQAC00785 SQAC00790 SQAC00791 SQAC00795 SQAC01037 SQAC01038 SQAC01047 SQAC00948 SQAC01510 SQAC01319 SQAC01353 SQAD00981 SQAD01069 SQAD01188 SQAA01702 SQAC01351 SQAC01378 SQAC01426 SQAC01427 SQAC01430 SQAC01434 SQAC01438 SQAC01495 SQAC01496 SQAD00470 SQAD00473
Recalling Firm/
Manufacturer		 GE Medical Systems, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
Manufacturer Reason
for Recall		Due to a manufacturing issue, certain Tec 6 Plus and Tec 800 series vaporizers can deliver less anesthetic agent than the vaporizer dial setting.
FDA Determined
Cause 2		Process control
ActionAn URGENT MEDICAL DEVICE CORRECTION notification letter dated 11/18/24 was sent to customers. Actions to be taken by Customer/User You can continue to use the vaporizer in accordance with the instructions in the User Reference Manual (URM) and the actions described below: 1. Perform the Output Concentration Check described in Appendix 1 for every impacted vaporizer (see Affected Product Details in this letter). " If a vaporizer passes the Output Concentration Check, you can continue to use that vaporizer. GE HealthCare recommends use of anesthetic agent monitoring during vaporizer use. " If a vaporizer fails the Output Concentration Check, you can continue to use that vaporizer with anesthetic agent monitoring until GE HealthCare corrects the vaporizer. " If a vaporizer fails the Output Concentration Check and anesthetic agent monitoring is not available, remove the vaporizer from service. 2. Please complete and return the attached Medical Device Notification Acknowledgement Response Form to ARC.FMI34139@gehealthcare.com 3. Please ensure all potential staff in your facility are made aware of this safety notification and the recommended actions. 4. Please retain this document for your records. If you have any questions or concerns regarding this notification, please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative.
Quantity in Commerce1594 units
DistributionUS Nationwide. Global Distribution.
Total Product Life CycleTPLC 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = CAD
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