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FDAFDA · Alimentos y medicamentos·N.º oficial 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.

Publicado el 30 de julio de 2014 · Inicio del retiro: 11 de junio de 2014

Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.

Qué peligro representa

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.

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
GE Healthcare, LLC
Distribuidor
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.
Lote
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
Clasificación de riesgo
Class I
Área (FDA)
device
País
United States

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