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Terminated

NICO Model 7300 Cardiopulmonary Management System

FDA Recall Z-1535-06 · Posted 2006-09-29

Recalling FirmRespironics Novametrix, LLC.
Recall StatusTerminated
Product CodeCCK
Date Initiated2006-08-11
Date Terminated2012-06-12
Product Quantity2,432 units

Reason for Recall

Audible alarm may not sound during an alert condition

Firm 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.

Root Cause

Other

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K041450MODIFICATION TO NICO WITH MARS, MODEL 7300Respironics Novametrix, Inc. · 2004-06-18K030886NICO WITH MARS, MODEL 7300Respironics Novametrix, Inc. · 2003-10-07K982499COSMO PLUS WITH NICO, MODEL 8200Novametrix Medical Systems, Inc. · 1998-10-16

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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