PHILIPS NM3 Monitor Model Number: 7900 PHILIPS NM3 Monitor, English Part Number: 1051674 PHILIPS NM3 Monitor, English, Refurbished Part Number : U1051674 PHILIPS NM3 Monitor, English, Demo Unit Part Number: DU1051674 PHILIPS NM3 Monitor, Spanish Part Number: 1060462 PHILIPS NM3 Monitor, French Part Number: 1060458 PHILIPS NM3 Monitor, Swedish Part Number:1062860 Intended use: Cardiac output monitoring, Spirometric and carbon dioxide monitoring, and Continuous, non-invasive monitoring of functional arterial oxygen saturation and pulse rate.
FDA Recall Z-3287-2011 · Posted 2011-09-30
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Recalling FirmRespironics Novametrix, LLC.
Recall StatusTerminated
Product CodeBZK
Date Initiated2011-07-29
Date Terminated2012-05-23
Product Quantity254 units
Reason for Recall
Pressure lines maybe occluded and display incorrect tidal volumes.
Firm Action
Respironics Novametrix, LLC on July 29, 2011 notified accounts via e-mail or tracked receipt, an Urgent - Medical Device Recall letter to notify customers of the issue and to instruct them on conditions for continued use. Monitors will need to be returned for functional performance testing at their facility. Customers can contact Respironics US Customer Service at 1-877-387-3311 for customers residing in the USA or +011 (203)697-6348 for International customers, if they have any questions or need additional information.
Root Cause
Manufacturing material removal
Distribution Pattern
Worldwide Distribution -- USA, Belgium, Canada, Chile, Columbia, Egypt, India, Italy, Spain, Saudi Arabia Thailand, GB, and Russia.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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