Trilogy Evo O2, Product numbers DE2100X13B, DS2100X11B, EE2100X15B, ES2100X15B, EU2100X15B, FR2100X14B, FX2100X15B, IA2100X15B, IN2100X15B, IN2100X19, IT2100X21B, JP2100X16B, LA2100X15B, ND2100X15B, RDE2100X13B, SP2100X26B
Recall
- Recall Number
- Z-2288-2021
- Event Number
- 88333
- Firm
- Philips Respironics, Inc.
- FEI Number
- 2518422
- Product Code
- NOU
- Status
- Open, Classified
- Root Cause
- Labeling design
- Initiated
- July 26, 2021
- Address
- 1001 Murry Ridge Ln, Murrysville, PA, 15668-8517
Description
Trilogy Evo O2, Product numbers DE2100X13B, DS2100X11B, EE2100X15B, ES2100X15B, EU2100X15B, FR2100X14B, FX2100X15B, IA2100X15B, IN2100X15B, IN2100X19, IT2100X21B, JP2100X16B, LA2100X15B, ND2100X15B, RDE2100X13B, SP2100X26B
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).
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)
Worldwide distribution - US nationwide distribution.
101 (FEMA Stockpile Only); 21077 (OUS)