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U.S. Department of Health and Human Services

Enforcement Report - Week of June 27, 2012

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Event Detail

Event ID 61843
Product Type Devices
Status Ongoing
Recalling Firm Nidek Medical Products Inc
City Birmingham
State AL
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-05-01
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern 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.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
NIDEK Medical MARK5 NUVO / M5C5, 115 V ~60Hz - 410 W. Oxygen Concentrator. Serial numbers 042-10000 through 102-07044 Class I Capacitor failure may result in a fire hazard and loss of supplemental oxygen. 18114 units Z-1782-2012
NIDEK Medical NUVO LITE MODEL 925 OCSI, 3LPM 230V - 60Hz - 280W. Oxygen Concentrator. Serial numbers 042-10000 through 102-07044 Class I Capacitor failure may result in a fire hazard and loss of supplemental oxygen. 1599 units Z-1781-2012
NIDEK Medical NUVO LITE MODEL 925 OCSI, 230V - 50Hz - 300W. Oxygen Concentrator. Serial numbers 042-10000 through 102-07044 Class I Capacitor failure may result in a fire hazard and loss of supplemental oxygen. 14,585 units Z-1780-2012
NIDEK Medical NUVO LITE MODEL 520 STD, 115V - 60Hz - 330W. Oxygen Concentrator. Serial numbers 042-10000 through 102-07044 Class I Capacitor failure may result in a fire hazard and loss of supplemental oxygen. 3638 units Z-1779-2012
NIDEK Medical NUVO LITE MODEL 525 OCSI, 115V -60Hz - 330W. Oxygen Concentrator. Serial numbers 042-10000 through 102-07044 Class I Capacitor failure may result in a fire hazard and loss of supplemental oxygen. 730 units Z-1778-2012
NIDEK Medical MARK5 NUVO 8 /OCSI, 230 V~50/60Hz - 420 W. Oxygen Concentrator. Serial numbers 042-10000 through 102-07044 Class I Capacitor failure may result in a fire hazard and loss of supplemental oxygen. 335 units Z-1777-2012
NIDEK Medical MARK5 NUVO 8 STD, 115 V~60Hz - 500W. Oxygen Concentrator. Serial numbers 042-10000 through 102-07044 Class I Capacitor failure may result in a fire hazard and loss of supplemental oxygen. 82 units Z-1776-2012
NIDEK Medical M5C5/ MARK5 NUVO/OCSI, 230 V~50/60 Hz -420 W. Oxygen Concentrator. Serial numbers 042-10000 through 102-07044 Class I Capacitor failure may result in a fire hazard and loss of supplemental oxygen. Z-1775-2012
NIDEK Medical M5C5/ MARK5 NUVO/STD, 230 V~50/60 Hz - 420 W. Oxygen Concentrator. Serial numbers 042-10000 through 102-07044 Class I Capacitor failure may result in a fire hazard and loss of supplemental oxygen. 7889 units Z-1774-2012
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