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U.S. Department of Health and Human Services

Enforcement Report - Week of June 27, 2012

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Product Detail

Product Description NIDEK Medical NUVO LITE MODEL 925 OCSI, 230V - 50Hz - 300W. Oxygen Concentrator.
Recall Number Z-1780-2012
Classification Class I
Code Info Serial numbers 042-10000 through 102-07044
Product Distributed Qty 14,585 units
Reason For Recall Capacitor failure may result in a fire hazard and loss of supplemental oxygen.

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.
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