Company:Respironics Novametrix, LLC., .
Date of Enforcement Report 5/25/2011
Class ll:
PRODUCT
1) Philips NM3 Monitors, Model 7900 PHILIPS NM3 Monitor, English – P/N 1051674 PHILIPS NM3 Monitor, English Refurbished – P/N U1051674 PHILIPS NM3 Monitor, English, Demo Unit – P/N DU1051674 PHILIPS NM3 Monitor, Spanish – P/N 1060462 NM3 is a multi-parameter patient monitor that utilizes the FloTrak Elite module to perform some of the calculations. Recall # Z-2167-2011;
2) Philips FloTrak Elite modules: FloTrak Elite P/N 1044971 FloTrak Elite P/N 1051005 NM3 is a multi-parameter patient monitor that utilizes the FloTrak Elite module to perform some of the calculations. Recall # Z-2168-2011
REASON
Software: two displayed respiratory parameters are incorrect due to errors in the system software: MValv (alveolar minute ventilation) and Vt/kg (tidal volume/patient weight). In both instances, the displayed parameters are higher than actual..
RECALLING FIRM/MANUFACTURER
Respironics Novametrix, LLC., Wallingford, CT, by letter on January 4, 2011. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
220 units
DISTRIBUTION
Nationwide, Belgium, China, Columbia, Egypt, England, India, Italy, Saudi Arabia, and Spain
