Philips FloTrak Elite modules: FloTrak Elite P/N 1044971 FloTrak Elite P/N 1051005 NM3 is a multi-parameter patient moni
FDA device recall Z-2168-2011 · posted 2011-05-10 · Terminated
Recall details
- Recalling firm
- Respironics Novametrix, LLC.
- Reason for recall
- 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.
- Action taken
- Respironics issued Field Action Notification Letter via Fed'x on 1/4/11, notifying customers of the issue and to instruct them on conditions for continued use and return of the device. The device will be updated with revised software to correct the calculation errors. Any questions or need additional information about this recall action, Contact Respironics US Customer Service at 1-800-345-6443 for customers residing in the USA or +011 (203)697-6488 for International customers.
- Root cause
- Software design
- Status
- Terminated
- Quantity affected
- 38 units
- Distribution
- Nationwide Foreign: Belgium, China, Columbia, Egypt, England, India, Italy, Saudi Arabia, and Spain
- Date initiated
- 2011-01-04
- Date posted
- 2011-05-10
- Date terminated
- 2013-03-07
- Location
- Wallingford, CT
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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 |