NICO Model 7300 Cardiopulmonary Management System
This recall has been terminated (originally issued September 29, 2006).
- Company
- Respironics Novametrix, Llc.
- Recall Initiated
- August 11, 2006
- Posted
- September 29, 2006
- Terminated
- June 12, 2012
- Recall Number
- Z-1535-06
- Quantity
- 2,432 units
- Firm Location
- Wallingford, CT
- Official Source
- View on FDA website ↗
Reason for Recall
Audible alarm may not sound during an alert condition
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.
Lot / Code Info
All serial numbers beginning with 138
Root Cause
Other
Action Taken
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.