Datex-Ohmeda S/5 Single-Width Airway Module…

Date

July 30, 2014

Risk class

Class I (FDA's definition, 21 CFR 7.3(m): a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death)

Status

Terminated

Filed by

GE Healthcare, LLC

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.

Reason

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.

Distribution pattern

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.

Quantity

2,948 (761 units US, 2,187 units OUS)

Codes and lots

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…

Recall started

June 11, 2014

Device type

Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase

Root cause (FDA)

Device Design

What the company told customers

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.

Recall number

Z-2068-2014

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-2068-2014. The agency record governs; check it and the company before acting.