Z-1535-06

NICO Model 7300 Cardiopulmonary Management System

Name: Z-1535-06 NICO Model 7300 Cardiopulmonary Management System
Creator: Respironics Novametrix, LLC.
Published: 2006-08-11
License: https://open.fda.gov/license/

Respironics Novametrix, LLC. / initiated 2006-08-11 / Terminated

FDA source

Respironics Novametrix, LLC. began a recall of NICO Model 7300 Cardiopulmonary Management System on 2006-08-11. The reason FDA records is "Audible alarm may not sound during an alert condition". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1535-06
Status: Terminated
Initiated: 2006-08-11
Posted: 2006-09-29
Terminated: 2012-06-12
Recalling firm: Respironics Novametrix, LLC.
Product: NICO Model 7300 Cardiopulmonary Management System
Product code: CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Reason for recall: Audible alarm may not sound during an alert condition
FDA root cause: 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.
Product codes and lots: All serial numbers beginning with 138

Product code CCK

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)