Device Recall Servoi ventilator system

  • Modèle / numéro de série
    510k k041223 B052264 Article 64 87 800 Serial numbers 56001-58411
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    USA Nationwide Distribution
  • Description du dispositif
    Servo-i ventilator system || Product Usage: Intended for treatment and monitoring of patients in the range of neonates, infants and adults with respiratory failure or respiratory insufficiency.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Maquet Inc., 45 Barbour Pond Drive, Wayne NJ 07470
  • Société-mère du fabricant (2017)
  • Source
    USFDA

3 dispositifs médicaux avec un nom similaire

En savoir plus sur les données ici

  • Modèle / numéro de série
    510k k041223 B052264 Article 66 40 440 Serial numbers 19841-21664
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    USA Nationwide Distribution
  • Description du dispositif
    Servo-s ventilator system || Product Usage: Intended for treatment and monitoring of patients in the range of neonates, infants and adults with respiratory failure or respiratory insufficiency.
  • Manufacturer
  • Modèle / numéro de série
    SERVO-i Battery Module part number is 6487180. Notice pertains to Battery Modules manufactured between February 2010 and October 2012 with date codes between 1005 and 1243.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) and countries of: ALGERIA, ANDORRA, ANTILLES (Netherlands), ARGENTINA, ARUBA, AUSTRALIA, AUSTRIA, AZERBADJAN, BANGLADESH, BELARUS, BELGIUM, BOLIVIA, BOTSWANA, BRAZIL, BRUNEI, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, CONGO, COSTA RICA, CROATIA, CUBA, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, ECUADOR, EGYPT, EL SALVADOR, ESTONIA, YUGOSLAVIA (Former), FIJI, FINLAND, FRANCE, GEORGIA, GERMANY, GREECE, GUATEMALA, GUYANA, HONDURAS, HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRAN, IRAQ, IRELAND, ISRAEL, ITALY, JAMAICA, JAPAN, KENYA, KUWAIT, KYRGYZSTAN, LATVIA, LIBYA, LITHUANIA, LUXEMBURG, MACAU, MACEDONIA, MALAYSIA, MALDIVES, MARTINIQUE (French), MEXICO, MOLDAVIA, MOROCCO, NEPAL, NETHERLANDS, NEW CALEDONIA (French), NEW ZEALAND, NICARAGUA, NIGERIA, NORWAY, OMAN, PAKISTAN, PALESTINE, PANAMA, PAPUA NEW GUINEA, PARAGUAY, PERU, PHILIPPINES, POLAND, POLYNESIA (French), PORTUGAL, QATAR, REUNION (French), ROMANIA, RUSSIA, SAUDI ARABIA, SERBIA, SEYCHELLES, SINGAPORE, SLOVAK REPUBLIC, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SRI LANKA, SUDAN, SURINAM, SWEDEN, SWITZERLAND, SYRIA, TADJIKISTAN, TAIWAN, TANZANIA, THAILAND, TRINIDAD AND TOBAGO, TUNISIA, TURKEY, UKRAINE, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY, VATICAN city state, VENEZUELA, VIETNAM and YEMEN.
  • Description du dispositif
    Maquet Getinge Group battery modules for use with Maquet SERVO-i ventilator systems (Part #6487180). || Battery for use with the SERVO-i Ventilator System. The SERVO-i Ventilator System is intended for treating and monitoring patients ranging from neonates to adults with respiratory failure or insufficiency. The ventilator is equipped with at least 2, NiMH battery modules (Part No. 6487180) which automatically supply 12V DC Power in case of an AC power failure, ensuring that ventilator settings and stored data remain intact in the event of an AC power failure. The battery modules give the user a possibility to use the SERVO-i during intra-hospital transportation.
  • Manufacturer
  • Modèle / numéro de série
    Article number 64 87 800 Serial numbers: 34034, 34035, 34050, 34052, 34053, 34054, 34058,  34060 through 34083, 34085, 34086, 34087, 34088, 34090, 34096, 34099 through 34287, 34293, 34294, 34295, 34296, 34298, 34299, 34302, 34303, 34305, 34309, 34313, 34315, 34319, 34230, 34323, 34324, 34326, 34329, 34330, 34343, 34345, 34348, 34350, 34357, 34360, 34376, 34384, 34390, 34427, 34490, and 34530.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide.
  • Description du dispositif
    SERVO-i Ventilator System Maquet Critical Care, Solna, Sweden. The product is intended for treatment and monitoring of patients in the range of neonates, infants and adults with respiratory failure or respiratory insufficiency.
  • Manufacturer