Z-1775-2012Class I

NIDEK Medical M5C5/ MARK5 NUVO/OCSI, 230 V~50/60 Hz -420 W. Oxygen Concentrator

Name: Z-1775-2012 NIDEK Medical M5C5/ MARK5 NUVO/OCSI, 230 V~50/60 Hz -420 W. Oxygen Concentrator
Creator: Nidek Medical Products Inc
Published: 2012-05-01
License: https://open.fda.gov/license/

Nidek Medical Products Inc / initiated 2012-05-01 / Terminated / root cause: design

FDA source

Nidek Medical Products Inc began a recall of NIDEK Medical M5C5/ MARK5 NUVO/OCSI, 230 V~50/60 Hz -420 W. Oxygen Concentrator on 2012-05-01. FDA classified it as Class I and gives the reason as "Capacitor failure may result in a fire hazard and loss of supplemental oxygen". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1775-2012
Classification: Class I
Status: Terminated
Initiated: 2012-05-01
Posted: 2012-06-19
Terminated: 2017-03-21
Recalling firm: Nidek Medical Products Inc
Product: NIDEK Medical M5C5/ MARK5 NUVO/OCSI, 230 V~50/60 Hz -420 W. Oxygen Concentrator.
Product code: CAW Generator, Oxygen, Portable
Reason for recall: Capacitor failure may result in a fire hazard and loss of supplemental oxygen.
Root cause tag: design
FDA 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.
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.
Product codes and lots: Serial numbers 042-10000 through 102-07044

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1775-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1774-2012	Class I	Terminated	Voluntary: Firm initiated	2012-06-27	2012-06-19
Z-1775-2012	Class I	Terminated	Voluntary: Firm initiated	2012-06-27	2012-06-19
Z-1776-2012	Class I	Terminated	Voluntary: Firm initiated	2012-06-27	2012-06-19
Z-1777-2012	Class I	Terminated	Voluntary: Firm initiated	2012-06-27	2012-06-19
Z-1778-2012	Class I	Terminated	Voluntary: Firm initiated	2012-06-27	2012-06-19
Z-1779-2012	Class I	Terminated	Voluntary: Firm initiated	2012-06-27	2012-06-19
Z-1780-2012	Class I	Terminated	Voluntary: Firm initiated	2012-06-27	2012-06-19
Z-1781-2012	Class I	Terminated	Voluntary: Firm initiated	2012-06-27	2012-06-19
Z-1782-2012	Class I	Terminated	Voluntary: Firm initiated	2012-06-27	2012-06-19

Product code CAW

K032509Class IIMark 5 Nuvo (M5c5)Nidek Medical Products, Inc. / cleared 2004-03-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)