FDA Medical Device Recalls (openFDA)
Respironics Novametrix, LLC.: 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.
- Recall number
- Z-2168-2011
- Recalling firm
- Respironics Novametrix, LLC.
- Product
- 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.
- Status
- Terminated
- Initiated
- 2011-01-04
- Posted
- 2011-05-10
- Terminated
- 2013-03-07
- Reason
- 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.
- Root cause
- Software design
- Action
- 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.
- Quantity
- 38 units
- Distribution
- Nationwide Foreign: Belgium, China, Columbia, Egypt, England, India, Italy, Saudi Arabia, and Spain
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K080652","K091459","K092217"]
- PMA numbers
- not on file
- Product code
- not on file
- Firm FEI
- 1219324
- Firm city
- Wallingford
- Firm state
- CT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28