Events

Recall of NICO Cardiopulmonary Management System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Respironics Novametrix, LLC..

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
    36081
  • Event Risk Class
    Class 2
  • Event Number
    Z-1535-06
  • Event Initiated Date
    2006-08-11
  • Event Date Posted
    2006-09-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-06-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=47918
  • 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
    Cardiopulmonary Management System - Product Code CCK
  • Reason
    Audible alarm may not sound during an alert condition.
  • Action
    Respironics notified consignees of the problem with the audible alarm by certified letter on 8/28/06. The correction requires replacement of a speaker upgrade kit.

Device

NICO Cardiopulmonary Management System
  • Model / Serial
    All serial numbers beginning with 138
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution --- USA and countries of United Arab Emirates, Argentina, Austria, Australia, Belgium, Bulgaria, Bahrain, Brazil, Canada, Canton of Aargau Switzerland, Chile, China, Columbia, Costa Rica, Czech Republic, Germany, Denmark, Algeria, Ecuador, Egypt, Spain, Finland, France, Great Britain, Guam, Hong Kong, Hungary, Ireland, India, Italy, Jamaica, Jordon, Japan, Korea, Kuwait, Lebanon, Lithuania, Morocco, Mexico, Malaysia, Netherlands, Norway, New Zealand, Panama, Peru, Phillippines, Puerto Rico, Portugal, Qatar, Russia, Saudi Arabia, Sweden, Singapore, Slovania, Slovakia, Thailand, Turkey, Taiwan, Uruguay, Venezuala, and South Africa.
  • Product Description
    NICO Model 7300 || Cardiopulmonary Management System
  • Manufacturer
    Respironics Novametrix, LLC.

Manufacturer

Respironics Novametrix, LLC.
  • Manufacturer Address
    Respironics Novametrix, LLC., 5 Technology Dr, Wallingford CT 06492-1942
  • Source
    USFDA