FDA-Device2012-06-27Class I
NIDEK Medical M5C5/ MARK5 NUVO/STD, 230 V~50/60 Hz - 420 W. Oxygen Concentrator.
Nidek Medical Products Inc
Hazard
Capacitor failure may result in a fire hazard and loss of supplemental oxygen.
Sold states
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.
Affected count
7889 units
Manufactured in
3949 Valley East Industrial Dr, N/A, Birmingham, AL, United States
Products
NIDEK Medical M5C5/ MARK5 NUVO/STD, 230 V~50/60 Hz - 420 W. Oxygen Concentrator.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1774-2012Don't want to check this manually?
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