FDA Medical Device Recalls (openFDA)
Respironics Novametrix, LLC.: NICO Model 7300 Cardiopulmonary Management System
- Recall number
- Z-1535-06
- Recalling firm
- Respironics Novametrix, LLC.
- Product
- NICO Model 7300 Cardiopulmonary Management System
- Status
- Terminated
- Initiated
- 2006-08-11
- Posted
- 2006-09-29
- Terminated
- 2012-06-12
- 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 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, serial or model codes
- All serial numbers beginning with 138
- 510(k) numbers
- ["K030886","K041450","K982499"]
- PMA numbers
- not on file
- Product code
- CCK
- Firm FEI
- 1219324
- Firm city
- Wallingford
- Firm state
- CT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28