| Class 1 Device Recall NIDEK Medical NUVO LITE MODEL 925 OCSI, 230V 50Hz 300W | |
Date Initiated by Firm | May 01, 2012 |
Date Posted | June 19, 2012 |
Recall Status1 |
Terminated 3 on March 21, 2017 |
Recall Number | Z-1780-2012 |
Recall Event ID |
61843 |
510(K)Number | K032509 |
Product Classification |
Generator, oxygen, portable - Product Code CAW
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Product | NIDEK Medical NUVO LITE MODEL 925 OCSI, 230V - 50Hz - 300W.
Oxygen Concentrator. |
Code Information |
Serial numbers 042-10000 through 102-07044 |
Recalling Firm/ Manufacturer |
Nidek Medical Products Inc 3949 Valley East Industrial Dr Birmingham AL 35217
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For Additional Information Contact | Mr. Van Muth 205-856-7200 Ext. 242 |
Manufacturer Reason for Recall | Capacitor failure may result in a fire hazard and loss of supplemental oxygen. |
FDA Determined Cause 2 | 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 in Commerce | 14,585 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, 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. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = CAW
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