Recall Z-1777-2012
Nidek Medical Products Inc · initiated May 1, 2012
Class I – dangerous or defective products that could cause serious health problems or death
Product
NIDEK Medical MARK5 NUVO 8 /OCSI, 230 V~50/60Hz - 420 W. Oxygen Concentrator.
Codes / lots: Serial numbers 042-10000 through 102-07044
Reason for recall
Capacitor failure may result in a fire hazard and loss of supplemental oxygen.
FDA-determined cause: Component design/selection
Action taken
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.
Details
- Recall number
- Z-1777-2012
- Initiated
- May 1, 2012
- Posted by FDA
- June 19, 2012
- Terminated
- March 21, 2017
- Product code
- CAW – Generator, Oxygen, Portable
- Quantity
- 335 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, IRAN, IRELAND, ISRAEL, ITALY, IVORY COAST, JAPAN, KAZAKHSTAN, KINGDOM OF SAUDI ARABIA, KUWAIT…
- Recalling firm
- Nidek Medical Products Inc, Birmingham, AL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1774-2012 Class I | NIDEK Medical M5C5/ MARK5 NUVO/STD, 230 V~50/60 Hz - 420 W. Oxygen Concentrator.Capacitor failure may result in a fire hazard and loss of supplemental oxygen. | 05/01/2012Terminated |
| Z-1775-2012 Class I | NIDEK Medical M5C5/ MARK5 NUVO/OCSI, 230 V~50/60 Hz -420 W. Oxygen Concentrator.Capacitor failure may result in a fire hazard and loss of supplemental oxygen. | 05/01/2012Terminated |
| Z-1776-2012 Class I | NIDEK Medical MARK5 NUVO 8 STD, 115 V~60Hz - 500W. Oxygen Concentrator.Capacitor failure may result in a fire hazard and loss of supplemental oxygen. | 05/01/2012Terminated |
| Z-1778-2012 Class I | NIDEK Medical NUVO LITE MODEL 525 OCSI, 115V -60Hz - 330W. Oxygen Concentrator.Capacitor failure may result in a fire hazard and loss of supplemental oxygen. | 05/01/2012Terminated |
| Z-1779-2012 Class I | NIDEK Medical NUVO LITE MODEL 520 STD, 115V - 60Hz - 330W. Oxygen Concentrator.Capacitor failure may result in a fire hazard and loss of supplemental oxygen. | 05/01/2012Terminated |
| Z-1780-2012 Class I | NIDEK Medical NUVO LITE MODEL 925 OCSI, 230V - 50Hz - 300W. Oxygen Concentrator.Capacitor failure may result in a fire hazard and loss of supplemental oxygen. | 05/01/2012Terminated |
| Z-1781-2012 Class I | NIDEK Medical NUVO LITE MODEL 925 OCSI, 3LPM 230V - 60Hz - 280W. Oxygen Concentrator.Capacitor failure may result in a fire hazard and loss of supplemental oxygen. | 05/01/2012Terminated |
| Z-1782-2012 Class I | NIDEK Medical MARK5 NUVO / M5C5, 115 V ~60Hz - 410 W. Oxygen Concentrator.Capacitor failure may result in a fire hazard and loss of supplemental oxygen. | 05/01/2012Terminated |