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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 Systemsee related information
Date Initiated by FirmAugust 11, 2006
Date PostedSeptember 29, 2006
Recall Status1 Terminated 3 on June 12, 2012
Recall NumberZ-1535-06
Recall Event ID 36081
510(K)NumberK030886 K041450 K982499 
Product Classification Cardiopulmonary Management System - Product Code CCK
ProductNICO 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 ContactKevin Mader
203-697-6466
Manufacturer Reason
for Recall		Audible alarm may not sound during an alert condition
FDA Determined
Cause 2		Other
ActionRespironics 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 Commerce2,432 units
DistributionWorldwide 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 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 = CCK
510(K)s with Product Code = CCK
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