Device Recall NIDEK Medical M5C5/ MARK5 NUVO/STD, 230 V50/60 Hz 420 W

  • Modèle / numéro de série
    Serial numbers 042-10000 through 102-07044
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) and the countries of ALBANIA, ALGERIA, AUSTRALIA, AUSTRIA, BELGIUM, BOLIVIA, BULGARIA, CAMBODIA, CHILE, CHINA, COLOMBIA, COSTA RICA, CYPRUS, CZECH REPUBLIC, ECUADOR, EGYPT, EL SALVADOR, ENGLAND, FRANCE, GERMANY, GREECE, GUATEMALA, HONG KONG, INDIA, INDONESIA, IRAN, IRELAND, ISRAEL, ITALY, IVORY COAST, JAPAN, KAZAKHSTAN, KINGDOM OF SAUDI ARABIA, KUWAIT, LEBANON, LIBYA, LITHUANIA, MALAYSIA, MEXICO, MOROCCO, MYANMAR, NAMIBIA, NEPAL, NEW ZEALAND, NIGERIA, PAKISTAN, PERU, PHILIPPPINES, PORTUGAL, REPUBLIC OF CHINA, REPUBLIC OF SOUTH AFRICA, RUSSIA, SERBIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SOUTH AUSTRALIA, SOUTH KOREA, SPAIN, SWITZERLAND, TAIWAN, TANZANIA, THAILAND, THE NETHERLANDS, TOGO, TUNISIA, TURKEY, UGANDA, UNITED ARAB EMIRATES, and VIETNAM.
  • Description du dispositif
    NIDEK Medical M5C5/ MARK5 NUVO/STD, 230 V~50/60 Hz - 420 W. || Oxygen Concentrator.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Nidek Medical Products Inc, 3949 Valley East Industrial Dr, Birmingham AL 35217
  • Société-mère du fabricant (2017)
  • Source
    USFDA