Trilogy Evo O2, Product numbers DE2100X13B, DS2100X11B, EE2100X15B, ES2100X15B, EU2100X15B, FR2100X14B, FX2100X15B, IA2100X15B, IN2100X15B, IN2100X19, IT2100X21B, JP2100X16B, LA2100X15B, ND2100X15B, RDE2100X13B, SP2100X26B
Reported: August 25, 2021 Initiated: July 26, 2021 #Z-2288-2021
Product Description
Trilogy Evo O2, Product numbers DE2100X13B, DS2100X11B, EE2100X15B, ES2100X15B, EU2100X15B, FR2100X14B, FX2100X15B, IA2100X15B, IN2100X15B, IN2100X19, IT2100X21B, JP2100X16B, LA2100X15B, ND2100X15B, RDE2100X13B, SP2100X26B
Reason for Recall
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).
Details
- Recalling Firm
- Philips Respironics, Inc.
- Units Affected
- 101 (FEMA Stockpile Only); 21077 (OUS)
- Distribution
- Worldwide distribution - US nationwide distribution.
- Location
- Murrysville, PA
Frequently Asked Questions
What product was recalled? ▼
Trilogy Evo O2, Product numbers DE2100X13B, DS2100X11B, EE2100X15B, ES2100X15B, EU2100X15B, FR2100X14B, FX2100X15B, IA2100X15B, IN2100X15B, IN2100X19, IT2100X21B, JP2100X16B, LA2100X15B, ND2100X15B, RDE2100X13B, SP2100X26B. Recalled by Philips Respironics, Inc.. Units affected: 101 (FEMA Stockpile Only); 21077 (OUS).
Why was this product recalled? ▼
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).
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 25, 2021. Severity: Moderate. Recall number: Z-2288-2021.
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