Recall Z-1778-2012 ยท CAW Generator, Oxygen, Portable
Nidek Medical Products Inc
NIDEK Medical NUVO LITE MODEL 525 OCSI, 115V -60Hz - 330W. Oxygen Concentrator.
| Date | Jun 19, 2012 (initiated May 1, 2012) |
| Status | Terminated |
| Reason | Capacitor failure may result in a fire hazard and loss of supplemental oxygen. |
| Root cause | Component design/selection |
| Action | Nidek Medical Products Inc sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated May 1, 2012 to affected customers. The letter identifies the product, problem, and the actions to be taken by the customers. The letter included a response form for customers to complete and return to the firm. Contact the the firm at 205-856-7200 ext. 242. |
| Quantity | 730 units |
| 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.