Device Recall EminiC

  • Model / Serial
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • 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.
  • Product Description
    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.
  • Manufacturer
  • 1 Event

Manufacturer

  • Manufacturer Address
    GE Healthcare, LLC, 3000 N Grandview Blvd, Waukesha WI 53188-1615
  • Manufacturer Parent Company (2017)
  • Source
    USFDA