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.
This recall has been terminated (originally issued May 10, 2011).
- Company
- Respironics Novametrix, Llc.
- Recall Initiated
- January 4, 2011
- Posted
- May 10, 2011
- Terminated
- March 7, 2013
- Recall Number
- Z-2168-2011
- Quantity
- 38 units
- Firm Location
- Wallingford, CT
- Official Source
- View on FDA website ↗
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.
Distribution
Nationwide Foreign: Belgium, China, Columbia, Egypt, England, India, Italy, Saudi Arabia, and Spain
Lot / Code Info
Serial Numbers: 167-000475 167-000496 175 235 236 237 238 239 240 356 376 389 414 483 502 510 511 686 693 700 723 724 725 612 146 155 171 173 and 178
Root Cause
Software design
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.