FDA Medical Device Recalls (openFDA)
Philips Respironics, Inc.: Trilogy Evo O2, Product numbers DE2100X13B, DS2100X11B, EE2100X15B, ES2100X15B, EU2100X15B, FR2100X14B, FX2100X15B, IA2100X15B, IN2100X15B, IN2100X19, IT2100X21B, JP2100X16B, LA2100X15B, ND2100X15B, RDE2100X13B, SP2100X26B
- Recall number
- Z-2288-2021
- Recalling firm
- Philips Respironics, Inc.
- Product
- Trilogy Evo O2, Product numbers DE2100X13B, DS2100X11B, EE2100X15B, ES2100X15B, EU2100X15B, FR2100X14B, FX2100X15B, IA2100X15B, IN2100X15B, IN2100X19, IT2100X21B, JP2100X16B, LA2100X15B, ND2100X15B, RDE2100X13B, SP2100X26B
- Status
- Open, Classified
- Initiated
- 2021-07-26
- Posted
- not on file
- Terminated
- not on file
- Reason
- Two software issues have been identified related to pressure increase in the device: The first issue is described as "Infant/Pediatric EFS Calibration Pressure Increase" and the second issue is described as "Pressure Drift (Continuous Usage).
- Root cause
- Labeling design
- Action
- On July 26, 2021, the firm issued Urgent Medical Device Correction letters to affected customers. Customers were advised of the two software issues that the firm had identified related to pressure increase. Customers received guidance on how to identify affected products: Devices with software versions devices with software versions 1.02.01.00, 1.03.05.00, 1.03.07.00, 1.04.02.00, 1.04.06, 1.05.01 and 1.06.02 are impacted. Customers were provided with actions to take until the upcoming software fix is implemented on your device. Philips will be releasing a software correction to resolve this issue, and will contact customers when the software correction is released. If you need any further information or support concerning this issue, please contact Philips Customer Care Solutions Center Trilogy Evo: +1-800-345-6443 Option 2, Option 1 (Available 24/7) Trilogy EV300: +1-800-722-9377 (Available 24/7)
- Quantity
- 101 (FEMA Stockpile Only); 21077 (OUS)
- Distribution
- Worldwide distribution - US nationwide distribution.
- Lot, serial or model codes
- Software version numbers 1.02.01.00, 1.03.05.00, 1.03.07.00, 1.04.02.00, 1.04.06, 1.05.01, and 1.06.02
- 510(k) numbers
- ["K181166"]
- PMA numbers
- not on file
- Product code
- NOU
- Firm FEI
- 2518422
- Firm city
- Murrysville
- Firm state
- PA
- 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