Recall Z-1535-06 ยท CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Respironics Novametrix, LLC.
NICO Model 7300 Cardiopulmonary Management System
| Date | Sep 29, 2006 (initiated Aug 11, 2006) |
| Status | Terminated |
| Reason | Audible alarm may not sound during an alert condition |
| 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 | 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 |
| FDA record | Open on fda.gov |