PHILIPS NM3 Monitor Model Number: 7900 PHILIPS NM3 Monitor, English Part Number: 1051674 PHILIPS NM3 Monitor, English, R
FDA device recall Z-3287-2011 · posted 2011-09-30 · Terminated
Recall details
- Recalling firm
- Respironics Novametrix, LLC.
- Reason for recall
- Pressure lines maybe occluded and display incorrect tidal volumes.
- Action taken
- 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
- Status
- Terminated
- Product code
- BZK
- Quantity affected
- 254 units
- Distribution
- Worldwide Distribution -- USA, Belgium, Canada, Chile, Columbia, Egypt, India, Italy, Spain, Saudi Arabia Thailand, GB, and Russia.
- Date initiated
- 2011-07-29
- Date posted
- 2011-09-30
- Date terminated
- 2012-05-23
- 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 |
|---|---|---|
| MERCURY VCO2 (K092217) | Respironics Novametrix, Inc. | 2009-08-21 |
| PHILIPS NM3 MONITOR, MODEL 7900 (K091459) | Respironics Novametrix, LLC | 2009-07-28 |
| MERCURY VCO2 MODULE WITH CAPNOSTAT 5 (K080652) | Respironics Novametrix, LLC | 2008-06-20 |