| |
Class 1 Device Recall EminiC |
 |
| Date Initiated by Firm |
June 11, 2014 |
| Date Posted |
July 18, 2014 |
| Recall Status1 |
Terminated 3 on March 29, 2016 |
| Recall Number |
Z-2068-2014 |
| Recall Event ID |
68344 |
| 510(K)Number |
K052582 K043276
|
| Product Classification |
Analyzer, gas, carbon-dioxide, gaseous-phase - Product Code CCK
|
| Product |
DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES.
DATEX-OHMEDA S/5TM FM WITH L-FICU04 ANDL-FICUO4A SOFTWARE AND N-FCREC MODULE **(OUS only).
E-miniC and accessories is indicated for monitoring C02 and respiration rate of all hospital patients. |
| Code Information |
Serial # Model # 6837005 E-MINIC-00 6838210 E-MINIC-00 6845207 E-MINIC-00 6845218 E-MINIC-00 6845228 E-MINIC-00 6845248 E-MINIC-00 6860768 E-MINIC-00 6860858 E-MINIC-00 6876048 E-MINIC-00 6876050 E-MINIC-00 6876052 E-MINIC-00 6876054 E-MINIC-00 6878048 E-MINIC-00 6888716 E-MINIC-00 6888726 E-MINIC-00 6888755 E-MINIC-00 6889935 E-MINIC-00 6889950 E-MINIC-00 6891094 E-MINIC-00 6891114 E-MINIC-00 6891115 E-MINIC-00 6891116 E-MINIC-00 6891117 E-MINIC-00 6891121 E-MINIC-00 6891130 E-MINIC-00 6891137 E-MINIC-00 6891139 E-MINIC-00 6892616 E-MINIC-00 6892626 E-MINIC-00 6827924 E-MINIC-00 6829318 E-MINIC-00 6829321 E-MINIC-00 6832785 E-MINIC-00 6832787 E-MINIC-00 6832788 E-MINIC-00 6832789 E-MINIC-00 6832791 E-MINIC-00 6832795 E-MINIC-00 6832796 E-MINIC-00 6832797 E-MINIC-00 6832802 E-MINIC-00 6832803 E-MINIC-00 6832804 E-MINIC-00 6832805 E-MINIC-00 6832813 E-MINIC-00 6832815 E-MINIC-00 6832824 E-MINIC-00 6832825 E-MINIC-00 6832831 E-MINIC-00 6834874 E-MINIC-00 6834877 E-MINIC-00 6834880 E-MINIC-00 6834883 E-MINIC-00 6834884 E-MINIC-00 6834885 E-MINIC-00 6834886 E-MINIC-00 6834887 E-MINIC-00 6834888 E-MINIC-00 6834889 E-MINIC-00 6834890 E-MINIC-00 6834891 E-MINIC-00 6834892 E-MINIC-00 6834893 E-MINIC-00 6834894 E-MINIC-00 6834895 E-MINIC-00 6834896 E-MINIC-00 6834898 E-MINIC-00 6834899 E-MINIC-00 6834902 E-MINIC-00 6834903 E-MINIC-00 6834904 E-MINIC-00 6834907 E-MINIC-00 6834909 E-MINIC-00 6834910 E-MINIC-00 6834911 E-MINIC-00 6834913 E-MINIC-00 6834914 E-MINIC-00 6834915 E-MINIC-00 6834916 E-MINIC-00 6834917 E-MINIC-00 6834918 E-MINIC-00 6834919 E-MINIC-00 6834920 E-MINIC-00 6834921 E-MINIC-00 6834922 E-MINIC-00 6836999 E-MINIC-00 6837002 E-MINIC-00 6837003 E-MINIC-00 6837010 E-MINIC-00 6837011 E-MINIC-00 6837013 E-MINIC-00 6838187 E-MINIC-00 6838196 E-MINIC-00 6838197 E-MINIC-00 6838198 E-MINIC-00 6842192 E-MINIC-00 6842196 E-MINIC-00 6842198 E-MINIC-00 6842212 E-MINIC-00 6842221 E-MINIC-00 6848886 E-MINIC-00 6848887 E-MINIC-00 6848888 E-MINIC-00 6852650 E-MINIC-00 6852655 E-MINIC-00 6855674 E-MINIC-00 6860683 E-MINIC-00 6860685 E-MINIC-00 6860698 E-MINIC-00 6860750 E-MINIC-00 6873156 E-MINIC-00 6879423 E-MINIC-00 6883991 E-MINIC-00 6883994 E-MINIC-00 6883995 E-MINIC-00 6883997 E-MINIC-00 6884000 E-MINIC-00 6884007 E-MINIC-00 6884014 E-MINIC-00 6884016 E-MINIC-00 6884022 E-MINIC-00 6884023 E-MINIC-00 6887178 E-MINIC-00 6887182 E-MINIC-00 6887183 E-MINIC-00 6887185 E-MINIC-00 6887186 E-MINIC-00 6887187 E-MINIC-00 6887189 E-MINIC-00 6887190 E-MINIC-00 6887194 E-MINIC-00 6887195 E-MINIC-00 6887199 E-MINIC-00 6887201 E-MINIC-00 6887203 E-MINIC-00 6887206 E-MINIC-00 6887209 E-MINIC-00 6887210 E-MINIC-00 6887221 E-MINIC-00 6887222 E-MINIC-00 6888655 E-MINIC-00 6888670 E-MINIC-00 6888672 E-MINIC-00 6888681 E-MINIC-00 6888683 E-MINIC-00 6888684 E-MINIC-00 6888686 E-MINIC-00 6888688 E-MINIC-00 6888699 E-MINIC-00 6888703 E-MINIC-00 6888749 E-MINIC-00 6888750 E-MINIC-00 6888754 E-MINIC-00 6888771 E-MINIC-00 6888772 E-MINIC-00 6888773 E-MINIC-00 6889916 E-MINIC-00 6889939 E-MINIC-00 6889967 E-MINIC-00 6891144 E-MINIC-00 6891146 E-MINIC-00 6891148 E-MINIC-00 6891150 E-MINIC-00 6891152 E-MINIC-00 6891162 E-MINIC-00 6891180 E-MINIC-00 6891182 E-MINIC-00 6891184 E-MINIC-00 6896279 E-MINIC-00 6896303 E-MINIC-00 6838209 E-MINIC-00 6838211 E-MINIC-00 6838212 E-MINIC-00 6892655 E-MINIC-00 6892720 E-MINIC-00 6832823 E-MINIC-00 6838243 E-MINIC-00 6838252 E-MINIC-00 6838256 E-MINIC-00 6838262 E-MINIC-00 6842175 E-MINIC-00 6842181 E-MINIC-00 6842190 E-MINIC-00 6842204 E-MINIC-00 6842206 E-MINIC-00 6842217 E-MINIC-00 6842218 E-MINIC-00 6842219 E-MINIC-00 6842224 E-MINIC-00 6842225 E-MINIC-00 6842226 E-MINIC-00 6842227 E-MINIC-00 6842228 E-MINIC-00 6842230 E-MINIC-00 6842231 E-MINIC-00 6842233 E-MINIC-00 6842234 E-MINIC-00 6842236 E-MINIC-00 6842239 E-MINIC-00 6842242 E-MINIC-00 6842244 E-MINIC-00 6848877 E-MINIC-00 6848878 E-MINIC-00 6848881 E-MINIC-00 6848883 E-MINIC-00 6848884 E-MINIC-00 6848885 E-MINIC-00 6848889 E-MINIC-00 6848895 E-MINIC-00 6848897 E-MINIC-00 6852617 E-MINIC-00 6852641 E-MINIC-00 6852656 E-MINIC-00 6852662 E-MINIC-00 6852667 E-MINIC-00 6855627 E-MINIC-00 6855630 E-MINIC-00 6855719 E-MINIC-00 6860661 E-MINIC-00 6860720 E-MINIC-00 6860799 E-MINIC-00 6860821 E-MINIC-00 6860823 E-MINIC-00 6860825 E-MINIC-00 6860827 E-MINIC-00 6867789 E-MINIC-00 6870556 E-MINIC-00 6870574 E-MINIC-00 6870594 E-MINIC-00 6873165 E-MINIC-00 6873182 E-MINIC-00 6873190 E-MINIC-00 6876007 E-MINIC-00 6878050 E-MINIC-00 6878054 E-MINIC-00 6878056 E-MINIC-00 6883990 E-MINIC-00 6883998 E-MINIC-00 6884001 E-MINIC-00 6884006 E-MINIC-00 6884008 E-MINIC-00 6884010 E-MINIC-00 6884015 E-MINIC-00 6884020 E-MINIC-00 6887188 E-MINIC-00 6887198 E-MINIC-00 6887204 E-MINIC-00 6887211 E-MINIC-00 6887215 E-MINIC-00 6887216 E-MINIC-00 6887226 E-MINIC-00 6888661 E-MINIC-00 6888711 E-MINIC-00 6888719 E-MINIC-00 6888724 E-MINIC-00 6889920 E-MINIC-00 6889936 E-MINIC-00 6889942 E-MINIC-00 6889943 E-MINIC-00 6889948 E-MINIC-00 6889954 E-MINIC-00 6889957 E-MINIC-00 6889958 E-MINIC-00 6889959 E-MINIC-00 6889963 E-MINIC-00 6889966 E-MINIC-00 6891059 E-MINIC-00 6891069 E-MINIC-00 6891070 E-MINIC-00 6891080 E-MINIC-00 6891081 E-MINIC-00 6891090 E-MINIC-00 6891131 E-MINIC-00 6891143 E-MINIC-00 6892659 E-MINIC-00 6892665 E-MINIC-00 6892676 E-MINIC-00 6892680 E-MINIC-00 6892681 E-MINIC-00 6892694 E-MINIC-00 6892700 E-MINIC-00 6892701 E-MINIC-00 6895014 E-MINIC-00 6896275 E-MINIC-00 6896372 E-MINIC-00 6898678 E-MINIC-00 6898687 E-MINIC-00 6898696 E-MINIC-00 6838247 E-MINIC-00 6838251 E-MINIC-00 6838254 E-MINIC-00 6838259 E-MINIC-00 6842167 E-MINIC-00 6842182 E-MINIC-00 6868294 E-MINIC-00 6868320 E-MINIC-00 6870587 E-MINIC-00 6873125 E-MINIC-00 6873128 E-MINIC-00 6873130 E-MINIC-00 6873131 E-MINIC-00 6873139 E-MINIC-00 6873141 E-MINIC-00 6824774 E-MINIC-00 6824782 E-MINIC-00 6824783 E-MINIC-00 6860780 E-MINIC-00 6845224 E-MINIC-00 6845235 E-MINIC-00 6824790 E-MINIC-00 6824792 E-MINIC-00 6824797 E-MINIC-00 6824799 E-MINIC-00 6824800 E-MINIC-00 6824802 E-MINIC-00 6824804 E-MINIC-00 6824811 E-MINIC-00 6824812 E-MINIC-00 6824818 E-MINIC-00 6832801 E-MINIC-00 6832817 E-MINIC-00 6834901 E-MINIC-00 6836976 E-MINIC-00 6836980 E-MINIC-00 6829311 E-MINIC-00 6848912 E-MINIC-00 6860830 E-MINIC-00 6832821 E-MINIC-00 6842180 E-MINIC-00 6860849 E-MINIC-00 6889956 E-MINIC-00 6891173 E-MINIC-00 6892607 E-MINIC-00 6832790 E-MINIC-00 6845227 E-MINIC-00 6891055 E-MINIC-00 6892614 E-MINIC-00 6822945 E-MINIC-00 6822949 E-MINIC-00 6832794 E-MINIC-00 6832812 E-MINIC-00 6836997 E-MINIC-00 6836998 E-MINIC-00 6838214 E-MINIC-00 6838224 E-MINIC-00 6838228 E-MINIC-00 6838236 E-MINIC-00 6838237 E-MINIC-00 6838245 E-MINIC-00 6842177 E-MINIC-00 6842241 E-MINIC-00 6845206 E-MINIC-00 6848890 E-MINIC-00 6848898 E-MINIC-00 6848908 E-MINIC-00 6848909 E-MINIC-00 6848913 E-MINIC-00 6848915 E-MINIC-00 6848916 E-MINIC-00 6848942 E-MINIC-00 6852653 E-MINIC-00 6852661 E-MINIC-00 6852678 E-MINIC-00 6860438 E-MINIC-00 6860667 E-MINIC-00 6860777 E-MINIC-00 6870568 E-MINIC-00 6873123 E-MINIC-00 6873154 E-MINIC-00 6888695 E-MINIC-00 6888712 E-MINIC-00 6888738 E-MINIC-00 6891128 E-MINIC-00 6891168 E-MINIC-00 6891175 E-MINIC-00 6891176 E-MINIC-00 6891178 E-MINIC-00 6891181 E-MINIC-00 6892618 E-MINIC-00 6892625 E-MINIC-00 6892646 E-MINIC-00 6892693 E-MINIC-00 6892698 E-MINIC-00 6868321 E-MINIC-00 6842220 E-MINIC-00 6848914 E-MINIC-00 6848924 E-MINIC-00 6848936 E-MINIC-00 6852611 E-MINIC-00 6852612 E-MINIC-00 6852619 E-MINIC-00 6852622 E-MINIC-00 6852664 E-MINIC-00 6852666 E-MINIC-00 6852668 E-MINIC-00 6852669 E-MINIC-00 6852674 E-MINIC-00 6852675 E-MINIC-00 6852676 E-MINIC-00 6852677 E-MINIC-00 6852679 E-MINIC-00 6852680 E-MINIC-00 6852681 E-MINIC-00 6852682 E-MINIC-00 6855629 E-MINIC-00 6855639 E-MINIC-00 6855643 E-MINIC-00 6855647 E-MINIC-00 6855649 E-MINIC-00 6855651 E-MINIC-00 6855653 E-MINIC-00 6855660 E-MINIC-00 6855661 E-MINIC-00 6855664 E-MINIC-00 6855671 E-MINIC-00 6855673 E-MINIC-00 6855678 E-MINIC-00 6855680 E-MINIC-00 6855681 E-MINIC-00 6855683 E-MINIC-00 6855685 E-MINIC-00 6855686 E-MINIC-00 6855691 E-MINIC-00 6855695 E-MINIC-00 6855699 E-MINIC-00 6855701 E-MINIC-00 6855702 E-MINIC-00 6855704 E-MINIC-00 6855705 E-MINIC-00 6855709 E-MINIC-00 6855712 E-MINIC-00 6855713 E-MINIC-00 6855715 E-MINIC-00 6855717 E-MINIC-00 6855718 E-MINIC-00 6855722 E-MINIC-00 6855725 E-MINIC-00 6883984 E-MINIC-00 6884013 E-MINIC-00 6884019 E-MINIC-00 6895016 E-MINIC-00 6896270 E-MINIC-00 6896308 E-MINIC-00 6896310 E-MINIC-00 6896312 E-MINIC-00 6896334 E-MINIC-00 6896351 E-MINIC-00 6896356 E-MINIC-00 6896357 E-MINIC-00 6898635 E-MINIC-00 6898659 E-MINIC-00 6898679 E-MINIC-00 6898693 E-MINIC-00 6898697 E-MINIC-00 6898706 E-MINIC-00 6898707 E-MINIC-00 6898708 E-MINIC-00 6898715 E-MINIC-00 6898716 E-MINIC-00 6898720 E-MINIC-00 6898724 E-MINIC-00 6898726 E-MINIC-00 6898727 E-MINIC-00 6898729 E-MINIC-00 6898732 E-MINIC-00 6832827 E-MINIC-00 6842222 E-MINIC-00 6842238 E-MINIC-00 6855656 E-MINIC-00 6855677 E-MINIC-00 6855720 E-MINIC-00 6855728 E-MINIC-00 6855729 E-MINIC-00 6855732 E-MINIC-00 6860439 E-MINIC-00 6860444 E-MINIC-00 6860450 E-MINIC-00 6860670 E-MINIC-00 6860672 E-MINIC-00 6860761 E-MINIC-00 6860772 E-MINIC-00 6860773 E-MINIC-00 6860778 E-MINIC-00 6883980 E-MINIC-00 6883986 E-MINIC-00 6883988 E-MINIC-00 6884003 E-MINIC-00 6884004 E-MINIC-00 6884005 E-MINIC-00 6887205 E-MINIC-00 6888687 E-MINIC-00 6888693 E-MINIC-00 6889965 E-MINIC-00 6891151 E-MINIC-00 6891174 E-MINIC-00 6892656 E-MINIC-00 6892672 E-MINIC-00 6892697 E-MINIC-00 6894976 E-MINIC-00 6894998 E-MINIC-00 6895005 E-MINIC-00 6895021 E-MINIC-00 6895022 E-MINIC-00 6895023 E-MINIC-00 6895025 E-MINIC-00 6896262 E-MINIC-00 6896264 E-MINIC-00 6896266 E-MINIC-00 6896268 E-MINIC-00 6896269 E-MINIC-00 6896271 E-MINIC-00 6896272 E-MINIC-00 6896273 E-MINIC-00 6896274 E-MINIC-00 6896276 E-MINIC-00 6896280 E-MINIC-00 6896282 E-MINIC-00 6896283 E-MINIC-00 6896287 E-MINIC-00 6896290 E-MINIC-00 6896291 E-MINIC-00 6896292 E-MINIC-00 6896294 E-MINIC-00 6896296 E-MINIC-00 6896297 E-MINIC-00 6896298 E-MINIC-00 6896301 E-MINIC-00 6896307 E-MINIC-00 6896309 E-MINIC-00 6896311 E-MINIC-00 6896313 E-MINIC-00 6896315 E-MINIC-00 6896317 E-MINIC-00 6896322 E-MINIC-00 6896323 E-MINIC-00 6896332 E-MINIC-00 6896333 E-MINIC-00 6896335 E-MINIC-00 6896336 E-MINIC-00 6896337 E-MINIC-00 6896338 E-MINIC-00 6896339 E-MINIC-00 6896340 E-MINIC-00 6896341 E-MINIC-00 6896342 E-MINIC-00 6896343 E-MINIC-00 6896344 E-MINIC-00 6896345 E-MINIC-00 6896346 E-MINIC-00 6896347 E-MINIC-00 6896348 E-MINIC-00 6896349 E-MINIC-00 6896350 E-MINIC-00 6896352 E-MINIC-00 6896353 E-MINIC-00 6896354 E-MINIC-00 6896355 E-MINIC-00 6896358 E-MINIC-00 6896359 E-MINIC-00 6896360 E-MINIC-00 6896361 E-MINIC-00 6896362 E-MINIC-00 6896363 E-MINIC-00 6896364 E-MINIC-00 6896365 E-MINIC-00 6896366 E-MINIC-00 6896367 E-MINIC-00 6896368 E-MINIC-00 6896369 E-MINIC-00 6896370 E-MINIC-00 6896371 E-MINIC-00 6896373 E-MINIC-00 6896374 E-MINIC-00 6896375 E-MINIC-00 6896376 E-MINIC-00 6898627 E-MINIC-00 6898628 E-MINIC-00 6898629 E-MINIC-00 6898631 E-MINIC-00 6898632 E-MINIC-00 6898633 E-MINIC-00 6898634 E-MINIC-00 6898636 E-MINIC-00 6898638 E-MINIC-00 6898639 E-MINIC-00 6898640 E-MINIC-00 6898641 E-MINIC-00 6898642 E-MINIC-00 6898643 E-MINIC-00 6898644 E-MINIC-00 6898645 E-MINIC-00 6898646 E-MINIC-00 6898649 E-MINIC-00 6898650 E-MINIC-00 6898651 E-MINIC-00 6898653 E-MINIC-00 6898654 E-MINIC-00 6898655 E-MINIC-00 6898656 E-MINIC-00 6898657 E-MINIC-00 6898658 E-MINIC-00 6898660 E-MINIC-00 6898661 E-MINIC-00 6898662 E-MINIC-00 6898663 E-MINIC-00 6898664 E-MINIC-00 6898665 E-MINIC-00 6898666 E-MINIC-00 6898667 E-MINIC-00 6898668 E-MINIC-00 6898669 E-MINIC-00 6898670 E-MINIC-00 6898671 E-MINIC-00 6898672 E-MINIC-00 6898673 E-MINIC-00 6898674 E-MINIC-00 6898675 E-MINIC-00 6898676 E-MINIC-00 6898677 E-MINIC-00 6898680 E-MINIC-00 6898681 E-MINIC-00 6898682 E-MINIC-00 6898683 E-MINIC-00 6898684 E-MINIC-00 6898685 E-MINIC-00 6898686 E-MINIC-00 6898688 E-MINIC-00 6898691 E-MINIC-00 6898699 E-MINIC-00 6898700 E-MINIC-00 6898703 E-MINIC-00 6898705 E-MINIC-00 6898710 E-MINIC-00 6898713 E-MINIC-00 6898717 E-MINIC-00 6898718 E-MINIC-00 6898719 E-MINIC-00 6898722 E-MINIC-00 6898723 E-MINIC-00 6898725 E-MINIC-00 6898728 E-MINIC-00 6898735 E-MINIC-00 6898737 E-MINIC-00 6898742 E-MINIC-00 6898746 E-MINIC-00 6898747 E-MINIC-00 6898748 E-MINIC-00 6898758 E-MINIC-00 6898759 E-MINIC-00 6898764 E-MINIC-00 6898766 E-MINIC-00 6898767 E-MINIC-00 6898773 E-MINIC-00 6898775 E-MINIC-00 6898776 E-MINIC-00 6898777 E-MINIC-00 6824807 E-MINIC-00 6824814 E-MINIC-00 6824815 E-MINIC-00 6824816 E-MINIC-00 6824821 E-MINIC-00 6827897 E-MINIC-00 6827938 E-MINIC-00 6829322 E-MINIC-00 6832806 E-MINIC-00 6832807 E-MINIC-00 6832808 E-MINIC-00 6832816 E-MINIC-00 6891063 E-MINIC-00 6891078 E-MINIC-00 6891084 E-MINIC-00 6891110 E-MINIC-00 6891113 E-MINIC-00 6891120 E-MINIC-00 6845231 E-MINIC-00 6855657 E-MINIC-00 6855662 E-MINIC-00 6855687 E-MINIC-00 6855688 E-MINIC-00 6860731 E-MINIC-00 6887197 E-MINIC-00 6888696 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E-MINIC-00-EN 6892661 E-MINIC-00-EN 6892666 E-MINIC-00-EN 6892667 E-MINIC-00-EN 6892669 E-MINIC-00-EN 6892670 E-MINIC-00-EN 6892673 E-MINIC-00-EN 6892674 E-MINIC-00-EN 6892677 E-MINIC-00-EN 6892685 E-MINIC-00-EN 6892686 E-MINIC-00-EN 6892688 E-MINIC-00-EN 6892706 E-MINIC-00-EN 6894977 E-MINIC-00-EN 6894981 E-MINIC-00-EN 6894982 E-MINIC-00-EN 6894987 E-MINIC-00-EN 6894988 E-MINIC-00-EN 6894989 E-MINIC-00-EN 6894990 E-MINIC-00-EN 6894992 E-MINIC-00-EN 6894993 E-MINIC-00-EN 6894994 E-MINIC-00-EN 6894995 E-MINIC-00-EN 6894996 E-MINIC-00-EN 6894997 E-MINIC-00-EN 6894999 E-MINIC-00-EN 6895000 E-MINIC-00-EN 6895002 E-MINIC-00-EN 6895003 E-MINIC-00-EN 6895004 E-MINIC-00-EN 6895006 E-MINIC-00-EN 6895007 E-MINIC-00-EN 6895008 E-MINIC-00-EN 6895009 E-MINIC-00-EN 6895010 E-MINIC-00-EN 6895011 E-MINIC-00-EN 6895012 E-MINIC-00-EN 6895013 E-MINIC-00-EN 6895015 E-MINIC-00-EN 6895017 E-MINIC-00-EN 6895018 E-MINIC-00-EN 6895019 E-MINIC-00-EN 6895020 E-MINIC-00-EN 6895026 E-MINIC-00-EN 6895027 E-MINIC-00-EN 6895028 E-MINIC-00-EN 6895030 E-MINIC-00-EN 6896259 E-MINIC-00-EN 6896260 E-MINIC-00-EN 6896265 E-MINIC-00-EN 6896284 E-MINIC-00-EN 6896286 E-MINIC-00-EN 6896289 E-MINIC-00-EN 6896295 E-MINIC-00-EN 6896299 E-MINIC-00-EN 6896302 E-MINIC-00-EN 6896319 E-MINIC-00-EN 6896321 E-MINIC-00-EN 6896325 E-MINIC-00-EN 6896328 E-MINIC-00-EN 6896329 E-MINIC-00-EN 6896330 E-MINIC-00-EN 6898736 E-MINIC-00-EN 6898740 E-MINIC-00-EN 6898743 E-MINIC-00-EN 6898744 E-MINIC-00-EN 6898749 E-MINIC-00-EN 6898750 E-MINIC-00-EN 6898751 E-MINIC-00-EN 6898762 E-MINIC-00-EN 6898763 E-MINIC-00-EN 6898768 E-MINIC-00-EN 6898770 E-MINIC-00-EN 6898771 E-MINIC-00-EN 6898774 E-MINIC-00-EN 6838231 E-MINIC-00-EN 6883972 E-MINIC-00-EN 6827918 E-MINIC-00-EN 6860700 E-MINIC-00-EN 6888721 E-MINIC-00-EN 6891083 E-MINIC-00-EN 6891093 E-MINIC-00-EN 6891096 E-MINIC-00-EN 6891099 E-MINIC-00-EN 6891100 E-MINIC-00-EN 6848880 E-MINIC-00-EN 6848892 E-MINIC-00-EN 6848931 E-MINIC-00-EN 6887192 E-MINIC-00-EN 6888725 E-MINIC-00-EN 6888767 E-MINIC-00-EN 6889918 E-MINIC-00-EN 6889926 E-MINIC-00-EN 6889927 E-MINIC-00-EN 6889933 E-MINIC-00-EN 6889934 E-MINIC-00-EN 6838255 E-MINIC-00-EN 6842165 E-MINIC-00-EN 6842174 E-MINIC-00-EN 6842176 E-MINIC-00-EN 6842183 E-MINIC-00-EN 6887223 E-MINIC-00-EN 6888692 E-MINIC-00-EN 6891095 E-MINIC-00-EN 6891108 E-MINIC-00-EN 6892649 E-MINIC-00-EN 6889952 E-MINIC-00-EN 6891045 E-MINIC-00-EN 6860665 E-MINIC-00-EN 6867681 M1013204 6875967 M1013204 6875971 M1013204 6875996 M1013204 6873208 M1013204 6875993 M1013204 6875998 M1013204 6884034 M1013204 6884044 M1013204 6884047 M1013204 6884048 M1013204 6884049 M1013204 6885857 M1013204 6885868 M1013204 6885869 M1013204 6885871 M1013204 6885872 M1013204 6885873 M1013204 6885874 M1013204 6885881 M1013204 6873201 M1013204 6873204 M1013204 6875997 M1013204 6827939 M1013204 6827946 M1013204 6827966 M1013204 6875988 M1013204 6870545 M1013204 6875942 M1013204 6875985 M1013204 6878240 M1013204 6873203 M1013204 6873216 M1013204 6873207 M1013204 6873214 M1013204 6867682 M1013204 6873198 M1013204 6873199 M1013204 6875939 M1013204 6875941 M1013204 6875945 M1013204 6875984 M1013204 6875987 M1013204 6845272 M1013204 6845278 M1013204 6845283 M1013204 6845286 M1013204 6870540 M1013204 6870542 M1013204 6873197 M1013204 6873215 M1013204 6875906 M1013204 6875932 M1013204 6875940 M1013204 6875974 M1013204 6867648 M1013204 6873205 M1013204 6875990 M1013204 6878239 M1013204 6884046 M1013204 6867654 M1013204 6873200 M1013204 6873212 M1013204 6875995 M1013204 6885855 M1013204 6829271 N-FC-00 6839565 N-FC-00 6839571 N-FC-00 6839575 N-FC-00 6839576 N-FC-00 6799192 N-FC-00 6829276 N-FC-00 6829284 N-FC-00 6829292 N-FC-00 6831245 N-FC-00 6831253 N-FC-00 6831254 N-FC-00 6831255 N-FC-00 6831256 N-FC-00 6831261 N-FC-00 6831262 N-FC-00 6831263 N-FC-00 6831264 N-FC-00 6831265 N-FC-00 6831268 N-FC-00 6831274 N-FC-00 6839572 N-FC-00 6839584 N-FC-00 6839592 N-FC-00 6839596 N-FC-00 6849858 N-FC-00 6849884 N-FC-00 6849886 N-FC-00 6849895 N-FC-00 6849897 N-FC-00 6849903 N-FC-00 6849904 N-FC-00 6849905 N-FC-00 6863479 N-FC-00 6863481 N-FC-00 6881148 N-FC-00 6881378 N-FC-00 6884073 N-FC-00 6889541 N-FC-00 6889543 N-FC-00 6881405 N-FC-00 6831252 N-FC-00 6863497 N-FC-00 6863506 N-FC-00 6881404 N-FC-00 6799201 N-FC-00 6829270 N-FC-00 6829278 N-FC-00 6829281 N-FC-00 6829282 N-FC-00 6829288 N-FC-00 6831240 N-FC-00 6831246 N-FC-00 6831275 N-FC-00 6837808 N-FC-00 6837810 N-FC-00 6839555 N-FC-00 6839558 N-FC-00 6839561 N-FC-00 6839573 N-FC-00 6839583 N-FC-00 6839593 N-FC-00 6839594 N-FC-00 6839595 N-FC-00 6849863 N-FC-00 6849896 N-FC-00 6849874 N-FC-00 6849879 N-FC-00 6849881 N-FC-00 6849883 N-FC-00 6849885 N-FC-00 6849889 N-FC-00 6849892 N-FC-00 6849894 N-FC-00 6863478 N-FC-00 6869027 N-FC-00 6869028 N-FC-00 6869030 N-FC-00 6869032 N-FC-00 6870920 N-FC-00 6870921 N-FC-00 6870922 N-FC-00 6870923 N-FC-00 6870925 N-FC-00 6870928 N-FC-00 6870930 N-FC-00 6870931 N-FC-00 6870932 N-FC-00 6870935 N-FC-00 6870937 N-FC-00 6870938 N-FC-00 6870939 N-FC-00 6870940 N-FC-00 6870941 N-FC-00 6870942 N-FC-00 6870943 N-FC-00 6870944 N-FC-00 6870945 N-FC-00 6870946 N-FC-00 6881384 N-FC-00 6881388 N-FC-00 6881393 N-FC-00 6881395 N-FC-00 6881396 N-FC-00 6881398 N-FC-00 6881403 N-FC-00 6884066 N-FC-00 6884067 N-FC-00 6884075 N-FC-00 6884083 N-FC-00 6885565 N-FC-00 6885566 N-FC-00 6885568 N-FC-00 6885569 N-FC-00 6885570 N-FC-00 6885571 N-FC-00 6885573 N-FC-00 6885574 N-FC-00 6885982 N-FC-00 6889544 N-FC-00 6889557 N-FC-00 6889559 N-FC-00 6889563 N-FC-00 6849893 N-FC-00 6829274 N-FC-00 6831237 N-FC-00 6885572 N-FC-00 6839568 N-FC-00 6839574 N-FC-00 6839597 N-FC-00 6839611 N-FC-00 6870958 N-FC-00 6799191 N-FC-00 6799193 N-FC-00 6799194 N-FC-00 6829286 N-FC-00 6829290 N-FC-00 6831266 N-FC-00 6831267 N-FC-00 6839556 N-FC-00 6839598 N-FC-00 6839599 N-FC-00 6839600 N-FC-00 6839601 N-FC-00 6849859 N-FC-00 6849873 N-FC-00 6849878 N-FC-00 6849880 N-FC-00 6849887 N-FC-00 6863496 N-FC-00 6870947 N-FC-00 6870948 N-FC-00 6870949 N-FC-00 6870950 N-FC-00 6870951 N-FC-00 6870952 N-FC-00 6879585 N-FC-00 6879586 N-FC-00 6879587 N-FC-00 6879588 N-FC-00 6881387 N-FC-00 6881399 N-FC-00 6881400 N-FC-00 6881401 N-FC-00 6885975 N-FC-00 6885990 N-FC-00 6829265 N-FC-00 6839603 N-FC-00 6839604 N-FC-00 6839605 N-FC-00 6839607 N-FC-00 6839608 N-FC-00 6839609 N-FC-00 6839610 N-FC-00 6839612 N-FC-00 6849856 N-FC-00 6849857 N-FC-00 6863505 N-FC-00 6831286 N-FC-00 6829268 N-FC-00 6831250 N-FC-00 6839557 N-FC-00 6839559 N-FC-00 6839570 N-FC-00 6839585 N-FC-00 6839586 N-FC-00 6839590 N-FC-00 6849901 N-FC-00 6863494 N-FC-00 6863500 N-FC-00 6863507 N-FC-00 6881380 N-FC-00 6831238 N-FC-00 6831251 N-FC-00 6831257 N-FC-00 6849867 N-FC-00 6839577 N-FC-00 6839578 N-FC-00 6839579 N-FC-00 6839580 N-FC-00 6839581 N-FC-00 6839582 N-FC-00 6839602 N-FC-00 6849861 N-FC-00 6849864 N-FC-00 6849865 N-FC-00 6849868 N-FC-00 6849869 N-FC-00 6849870 N-FC-00 6849871 N-FC-00 6849877 N-FC-00 6849888 N-FC-00 6849890 N-FC-00 6881147 N-FC-00 6881383 N-FC-00 6881406 N-FC-00 6884069 N-FC-00 6884079 N-FC-00 6884080 N-FC-00 6885973 N-FC-00 6885991 N-FC-00 6849898 N-FC-00 6849900 N-FC-00 6849902 N-FC-00 6863487 N-FC-00 6863489 N-FC-00 6863490 N-FC-00 6863492 N-FC-00 6863493 N-FC-00 6863495 N-FC-00 6863498 N-FC-00 6863501 N-FC-00 6863502 N-FC-00 6863503 N-FC-00 6881397 N-FC-00 6885567 N-FC-00 6884068 N-FC-00 6885989 N-FC-00 6889536 N-FC-00 6849875 N-FC-00 6849876 N-FC-00 6831272 N-FC-00 6829277 N-FC-00 6829280 N-FC-00 6829283 N-FC-00 6831241 N-FC-00 6831242 N-FC-00 6831243 N-FC-00 6831247 N-FC-00 6831248 N-FC-00 6831249 N-FC-00 6831277 N-FC-00 6831279 N-FC-00 6831280 N-FC-00 6831284 N-FC-00 6837809 N-FC-00 6837811 N-FC-00 6837812 N-FC-00 6837814 N-FC-00 6839553 N-FC-00 6839554 N-FC-00 6839560 N-FC-00 6839562 N-FC-00 6839563 N-FC-00 6839564 N-FC-00 6839566 N-FC-00 6839569 N-FC-00 6839587 N-FC-00 6839588 N-FC-00 6839589 N-FC-00 6849872 N-FC-00 6849891 N-FC-00 6849899 N-FC-00 6863482 N-FC-00 6863483 N-FC-00 6863484 N-FC-00 6863485 N-FC-00 6863486 N-FC-00 6863488 N-FC-00 6863491 N-FC-00 6863499 N-FC-00 6863504 N-FC-00 6869025 N-FC-00 6869026 N-FC-00 6869029 N-FC-00 6869031 N-FC-00 6869033 N-FC-00 6869034 N-FC-00 6870924 N-FC-00 6870926 N-FC-00 6870927 N-FC-00 6870929 N-FC-00 6870933 N-FC-00 6870934 N-FC-00 6870936 N-FC-00 6881385 N-FC-00 6881386 N-FC-00 6881389 N-FC-00 6881390 N-FC-00 6881391 N-FC-00 6881392 N-FC-00 6881394 N-FC-00 6884065 N-FC-00 6884070 N-FC-00 6884071 N-FC-00 6884072 N-FC-00 6884074 N-FC-00 6884081 N-FC-00 6884082 N-FC-00 6884084 N-FC-00 6885972 N-FC-00 6885974 N-FC-00 6885987 N-FC-00 6885988 N-FC-00 6889538 N-FC-00 6889539 N-FC-00 6889540 N-FC-00 6889551 N-FC-00 6889556 N-FC-00 6829269 N-FC-00 6829279 N-FC-00 6831269 N-FC-00 6831270 N-FC-00 6831281 N-FC-00 6837813 N-FC-00 6839567 N-FC-00 6829275 N-FC-00 6831278 N-FC-00 6837807 N-FC-00 6881402 N-FC-00 6829287 N-FC-00 6870959 N-FC-00 6881146 N-FC-00 6881377 N-FC-00 6881379 N-FC-00 6881381 N-FC-00 6839591 N-FC-00-EN 6831244 N-FC-00-EN 6831258 N-FC-00-EN 6831259 N-FC-00-EN 6831260 N-FC-00-EN 6884078 N-FC-00-EN 6849934 N-FCREC-00 6834302 N-FCREC-00 6834308 N-FCREC-00 6834309 N-FCREC-00 6834310 N-FCREC-00 6834311 N-FCREC-00 6834312 N-FCREC-00 6834313 N-FCREC-00 6834314 N-FCREC-00 6834315 N-FCREC-00 6834316 N-FCREC-00 6834317 N-FCREC-00 6834318 N-FCREC-00 6834319 N-FCREC-00 6834320 N-FCREC-00 6839180 N-FCREC-00 6839182 N-FCREC-00 6839183 N-FCREC-00 6839184 N-FCREC-00 6839185 N-FCREC-00 6839186 N-FCREC-00 6839187 N-FCREC-00 6839188 N-FCREC-00 6839189 N-FCREC-00 6839190 N-FCREC-00 6839191 N-FCREC-00 6839192 N-FCREC-00 6839193 N-FCREC-00 6839194 N-FCREC-00 6839195 N-FCREC-00 6839196 N-FCREC-00 6839197 N-FCREC-00 6839198 N-FCREC-00 6839199 N-FCREC-00 6839200 N-FCREC-00 6839201 N-FCREC-00 6839202 N-FCREC-00 6839203 N-FCREC-00 6839204 N-FCREC-00 6839205 N-FCREC-00 6839206 N-FCREC-00 6839207 N-FCREC-00 6839208 N-FCREC-00 6839209 N-FCREC-00 6839210 N-FCREC-00 6839211 N-FCREC-00 6846254 N-FCREC-00 6846256 N-FCREC-00 6846258 N-FCREC-00 6846259 N-FCREC-00 6849935 N-FCREC-00 6849940 N-FCREC-00 6849942 N-FCREC-00 6849946 N-FCREC-00 6849949 N-FCREC-00 6849950 N-FCREC-00 6863457 N-FCREC-00 6863459 N-FCREC-00 6863460 N-FCREC-00 6863462 N-FCREC-00 6863470 N-FCREC-00 6863475 N-FCREC-00 6877795 N-FCREC-00 6877796 N-FCREC-00 6879675 N-FCREC-00 6879678 N-FCREC-00 6879680 N-FCREC-00 6881407 N-FCREC-00 6877797 N-FCREC-00 6879677 N-FCREC-00 6863476 N-FCREC-00 6863477 N-FCREC-00 6876315 N-FCREC-00 6876321 N-FCREC-00 6876322 N-FCREC-00 6876324 N-FCREC-00 6876325 N-FCREC-00 6876326 N-FCREC-00 6876327 N-FCREC-00 6876331 N-FCREC-00 6876333 N-FCREC-00 6876334 N-FCREC-00 6877787 N-FCREC-00 6877788 N-FCREC-00 6877789 N-FCREC-00 6877790 N-FCREC-00 6877791 N-FCREC-00 6877792 N-FCREC-00 6877798 N-FCREC-00 6879589 N-FCREC-00 6879590 N-FCREC-00 6879591 N-FCREC-00 6879592 N-FCREC-00 6879593 N-FCREC-00 6879594 N-FCREC-00 6879595 N-FCREC-00 6879596 N-FCREC-00 6879597 N-FCREC-00 6879598 N-FCREC-00 6839765 N-FCREC-00 6877785 N-FCREC-00 6876323 N-FCREC-00 6881423 N-FCREC-00 6881424 N-FCREC-00 6849939 N-FCREC-00 6839181 N-FCREC-00 6846255 N-FCREC-00 6876332 N-FCREC-00 6877793 N-FCREC-00 6877794 N-FCREC-00 6879599 N-FCREC-00 6879673 N-FCREC-00 6879676 N-FCREC-00 6879679 N-FCREC-00 6879681 N-FCREC-00 6879682 N-FCREC-00 6879683 N-FCREC-00 6881144 N-FCREC-00 6881145 N-FCREC-00 6881409 N-FCREC-00 6881410 N-FCREC-00 6881411 N-FCREC-00 6881412 N-FCREC-00 6881413 N-FCREC-00 6881414 N-FCREC-00 6881415 N-FCREC-00 6881416 N-FCREC-00 6881417 N-FCREC-00 6881419 N-FCREC-00 6892569 N-FCREC-00 6849936 N-FCREC-00 6849937 N-FCREC-00 6849938 N-FCREC-00 6849941 N-FCREC-00 6881408 N-FCREC-00 6881418 N-FCREC-00 6830983 N-FCREC-00-EN 6830984 N-FCREC-00-EN 6830985 N-FCREC-00-EN 6830986 N-FCREC-00-EN 6830987 N-FCREC-00-EN 6830992 N-FCREC-00-EN 6830993 N-FCREC-00-EN 6839212 N-FCREC-00-EN 6839761 N-FCREC-00-EN 6839762 N-FCREC-00-EN 6839763 N-FCREC-00-EN 6839764 N-FCREC-00-EN 6839766 N-FCREC-00-EN 6839767 N-FCREC-00-EN 6839768 N-FCREC-00-EN 6846241 N-FCREC-00-EN 6846242 N-FCREC-00-EN 6846243 N-FCREC-00-EN 6846244 N-FCREC-00-EN 6846245 N-FCREC-00-EN 6846246 N-FCREC-00-EN 6846247 N-FCREC-00-EN 6846248 N-FCREC-00-EN 6846249 N-FCREC-00-EN 6846250 N-FCREC-00-EN 6846251 N-FCREC-00-EN 6846252 N-FCREC-00-EN 6846253 N-FCREC-00-EN 6846257 N-FCREC-00-EN 6846260 N-FCREC-00-EN 6849908 N-FCREC-00-EN 6849909 N-FCREC-00-EN 6849910 N-FCREC-00-EN 6849911 N-FCREC-00-EN 6849912 N-FCREC-00-EN 6849913 N-FCREC-00-EN 6849914 N-FCREC-00-EN 6849915 N-FCREC-00-EN 6849916 N-FCREC-00-EN 6849917 N-FCREC-00-EN 6849918 N-FCREC-00-EN 6849919 N-FCREC-00-EN 6849920 N-FCREC-00-EN 6849921 N-FCREC-00-EN 6849922 N-FCREC-00-EN 6849923 N-FCREC-00-EN 6849924 N-FCREC-00-EN 6849925 N-FCREC-00-EN 6849926 N-FCREC-00-EN 6849927 N-FCREC-00-EN 6849928 N-FCREC-00-EN 6849930 N-FCREC-00-EN 6849931 N-FCREC-00-EN 6849932 N-FCREC-00-EN 6849933 N-FCREC-00-EN 6849943 N-FCREC-00-EN 6849944 N-FCREC-00-EN 6849945 N-FCREC-00-EN 6849947 N-FCREC-00-EN 6849948 N-FCREC-00-EN 6849951 N-FCREC-00-EN 6849952 N-FCREC-00-EN 6849953 N-FCREC-00-EN 6849954 N-FCREC-00-EN 6849955 N-FCREC-00-EN 6863448 N-FCREC-00-EN 6863449 N-FCREC-00-EN 6863450 N-FCREC-00-EN 6863451 N-FCREC-00-EN 6863452 N-FCREC-00-EN 6863453 N-FCREC-00-EN 6863454 N-FCREC-00-EN 6863455 N-FCREC-00-EN 6863456 N-FCREC-00-EN 6863458 N-FCREC-00-EN 6863461 N-FCREC-00-EN 6863463 N-FCREC-00-EN 6863464 N-FCREC-00-EN 6863465 N-FCREC-00-EN 6863466 N-FCREC-00-EN 6863467 N-FCREC-00-EN 6863469 N-FCREC-00-EN 6863471 N-FCREC-00-EN 6863472 N-FCREC-00-EN 6863473 N-FCREC-00-EN 6863474 N-FCREC-00-EN 6876305 N-FCREC-00-EN 6876306 N-FCREC-00-EN 6876307 N-FCREC-00-EN 6876308 N-FCREC-00-EN 6876309 N-FCREC-00-EN 6876310 N-FCREC-00-EN 6876311 N-FCREC-00-EN 6876312 N-FCREC-00-EN 6876313 N-FCREC-00-EN 6876314 N-FCREC-00-EN 6876316 N-FCREC-00-EN 6876317 N-FCREC-00-EN 6876318 N-FCREC-00-EN 6876319 N-FCREC-00-EN 6876320 N-FCREC-00-EN 6876328 N-FCREC-00-EN 6876329 N-FCREC-00-EN 6876330 N-FCREC-00-EN 6877784 N-FCREC-00-EN 6877786 N-FCREC-00-EN 6879600 N-FCREC-00-EN 6879672 N-FCREC-00-EN 6879684 N-FCREC-00-EN 6879685 N-FCREC-00-EN 6881422 N-FCREC-00-EN 6881425 N-FCREC-00-EN 6881426 N-FCREC-00-EN 6881427 N-FCREC-00-EN 6881428 N-FCREC-00-EN 6881429 N-FCREC-00-EN 6881432 N-FCREC-00-EN 6881433 N-FCREC-00-EN 6881434 N-FCREC-00-EN 6881435 N-FCREC-00-EN 6881436 N-FCREC-00-EN 6905190 N-FCREC-00-EN 6905206 N-FCREC-00-EN 6879671 N-FCREC-00-EN 6849929 N-FCREC-00-EN 6863468 N-FCREC-00-EN 6879674 N-FCREC-00-EN |
Recalling Firm/
Manufacturer |
GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
|
| For Additional Information Contact |
Technical Support
262-513-4122
|
Manufacturer Reason
for Recall |
Failure of the CO2 detector in Single-width Airway and Extension modules, which may cause a slow continuous decrease of measured Et-/FiCO2 values. Incorrect Et CO2/Fi CO2 value may impair clinical decision making for both mechanically and spontaneously ventilated patients because of incorrect low CO2 values.
|
FDA Determined
Cause 2 |
Device Design |
| Action |
GE Healthcare sent an Urgent Medical Device Correction letter dated June 11, 2014, to all affected consignees. The letter described the Safety Issue, Safety Instructions, Affected Product Details, and Product Correction and Contact Information. For questions customers were instructed to contact Technical Support at 1-800-558-7044 or their local Service Representative. |
| Quantity in Commerce |
2,948 (761 units US, 2,187 units OUS) |
| Distribution |
Worldwide Distribution - USA nationwide, ARGENTINA, AUSTRALIA, AUSTRIA, BAHRAIN, BRAZIL, CANADA, CHILE, CHINA, Croatia, CZECH REPUBLIC, DENMARK, EGYPT, EL SALVADOR, FINLAND, FRANCE, GERMANY, GREECE, GUATEMALA, HONG KONG, INDIA, IRAQ, ISRAEL, ITALY, JAPAN, KAZAKHSTAN, REPUBLIC OF KOREA, MALAYSIA, NETHERLANDS, NEW ZEALAND, OMAN, PERU, POLAND, ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SPAIN, SWEDEN, SWITZERLAND, SYRIAN ARAB REPUBLIC, TAIWAN, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, VENEZUELA, LEBANON, REPUBLIC OF MALDOVIA, COSTA RICA, GABON, INDONESIA, JAMAICA, NIGERIA, NORWAY, NEPAL, PAKISTAN, PANAMA, PHILIPPINES, SENEGAL, SOUTH AFRICA, THAILAND, TUNISIA, and CAMBODIA. |
| 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.
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| 510(K) Database |
510(K)s with Product Code = CCK and Original Applicant = DATEX-OHMEDA
510(K)s with Product Code = CCK and Original Applicant = GE HEALTHCARE
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