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FDAFDA · Food and drugs·Recall number Z-2068-2014

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.

Published July 30, 2014 · Recall initiated: June 11, 2014

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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.

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
GE Healthcare, LLC
Distributor
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.
Lot
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 6
Risk classification
Class I
Area (FDA)
device
Country
United States

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