NICO Model 7300 Cardiopulmonary Management System
FDA device recall Z-1535-06 · posted 2006-09-29 · Terminated
Recall details
- Recalling firm
- Respironics Novametrix, LLC.
- Reason for recall
- Audible alarm may not sound during an alert condition
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- CCK
- Quantity affected
- 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, C
- Date initiated
- 2006-08-11
- Date posted
- 2006-09-29
- Date terminated
- 2012-06-12
- Location
- Wallingford, CT
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODIFICATION TO NICO WITH MARS, MODEL 7300 (K041450) | Respironics Novametrix, Inc. | 2004-06-18 |
| NICO WITH MARS, MODEL 7300 (K030886) | Respironics Novametrix, Inc. | 2003-10-07 |
| COSMO PLUS WITH NICO, MODEL 8200 (K982499) | Novametrix Medical Systems, Inc. | 1998-10-16 |