Z-1780-2012 Class I Terminated
FDA device recall Z-1780-2012 was initiated by Nidek Medical Products Inc on May 1, 2012 and is designated Class I. Reason for recall: Capacitor failure may result in a fire hazard and loss of supplemental oxygen. The recall status is terminated (terminated March 21, 2017). Affected quantity: 14,585 units.
Recall Details
- Product Type
- Devices
- Report Date
- June 27, 2012
- Initiation Date
- May 1, 2012
- Termination Date
- March 21, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 14,585 units
Product Description
Reason for Recall
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.