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U.S. Department of Health and Human Services

Class 1 Device Recall NIDEK Medical M5C5/ MARK5 NUVO/STD, 230 V50/60 Hz 420 W

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 Class 1 Device Recall NIDEK Medical M5C5/ MARK5 NUVO/STD, 230 V50/60 Hz 420 Wsee related information
Date Initiated by FirmMay 01, 2012
Date PostedJune 19, 2012
Recall Status1 Terminated 3 on March 21, 2017
Recall NumberZ-1774-2012
Recall Event ID 61843
510(K)NumberK032509 
Product Classification Generator, oxygen, portable - Product Code CAW
ProductNIDEK Medical M5C5/ MARK5 NUVO/STD, 230 V~50/60 Hz - 420 W. 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
For Additional Information ContactMr. 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
ActionNidek 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 Commerce7889 units
DistributionWorldwide 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 CycleTPLC Device Report
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.
510(K) Database510(K)s with Product Code = CAW
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