NIDEK Medical M5C5/ MARK5 NUVO/OCSI, 230 V~50/60 Hz -420 W. Oxygen Concentrator.
FDA device recall Z-1775-2012 · posted 2012-06-19 · Terminated
Recall details
- Recalling firm
- Nidek Medical Products Inc
- Reason for recall
- Capacitor failure may result in a fire hazard and loss of supplemental oxygen.
- 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.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- CAW
- 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, ECU
- Date initiated
- 2012-05-01
- Date posted
- 2012-06-19
- Date terminated
- 2017-03-21
- Location
- Birmingham, AL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MARK 5 NUVO (M5C5) (K032509) | Nidek Medical Products, Inc. | 2004-03-18 |