Events

Recall of Device Recall NIDEK Medical MARK5 NUVO 8 STD, 115 V60Hz 500W

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Nidek Medical Products Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    61843
  • Event Risk Class
    Class 1
  • Event Number
    Z-1776-2012
  • Event Initiated Date
    2012-05-01
  • Event Date Posted
    2012-06-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-03-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=109221
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Generator, oxygen, portable - Product Code CAW
  • Reason
    Capacitor failure may result in a fire hazard and loss of supplemental oxygen.
  • 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.

Device

Device Recall NIDEK Medical MARK5 NUVO 8 STD, 115 V60Hz 500W
  • Model / Serial
    Serial numbers 042-10000 through 102-07044
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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 Description
    NIDEK Medical MARK5 NUVO 8 STD, 115 V~60Hz - 500W. || Oxygen Concentrator.
  • Manufacturer
    Nidek Medical Products Inc

Manufacturer

Nidek Medical Products Inc
  • Manufacturer Address
    Nidek Medical Products Inc, 3949 Valley East Industrial Dr, Birmingham AL 35217
  • Manufacturer Parent Company (2017)
    Nidek Medical Products Inc
  • Source
    USFDA