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U.S. Department of Health and Human Services

Class 2 Device Recall NICO Cardiopulmonary Management System

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  Class 2 Device Recall NICO Cardiopulmonary Management System see related information
Date Initiated by Firm August 11, 2006
Date Posted September 29, 2006
Recall Status1 Terminated 3 on June 12, 2012
Recall Number Z-1535-06
Recall Event ID 36081
510(K)Number K982499  K030886  K041450  
Product Classification Cardiopulmonary Management System - Product Code CCK
Product NICO Model 7300
Cardiopulmonary Management System
Code Information All serial numbers beginning with 138
Recalling Firm/
Manufacturer		 Respironics Novametrix, LLC.
5 Technology Dr
Wallingford CT 06492-1942
For Additional Information Contact Kevin Mader
203-697-6466
Manufacturer Reason
for Recall		 Audible alarm may not sound during an alert condition
FDA Determined
Cause 2		 Other
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.
Quantity in Commerce 2,432 units
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.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = CCK and Original Applicant = NOVAMETRIX MEDICAL SYSTEMS, INC.
510(K)s with Product Code = CCK and Original Applicant = RESPIRONICS NOVAMETRIX, INC.
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