Recall Z-3287-2011 ยท BZK Spirometer, Monitoring (W/Wo Alarm)
Respironics Novametrix, LLC.
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 moni
| Date | Sep 30, 2011 (initiated Jul 29, 2011) |
| Status | Terminated |
| Reason | Pressure lines maybe occluded and display incorrect tidal volumes. |
| Root cause | Manufacturing material removal |
| 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. |
| Quantity | 254 units |
| Distribution | Worldwide Distribution -- USA, Belgium, Canada, Chile, Columbia, Egypt, India, Italy, Spain, Saudi Arabia Thailand, GB, and Russia. |
| FDA record | Open on fda.gov |