Reported Aug 25, 2021 · Ongoing
Trilogy Evo O2, Product numbers DE2100X13B, DS2100X11B, EE2100X15B, ES2100X15B, EU2100X15B, FR2100X14B, FX2100X15B,…
Philips Respironics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Philips Respironics, Inc. · 1001 Murry Ridge Ln · Murrysville, PA · 15668-8517
Is this the product you have?
Trilogy Evo O2Product numbers DE2100X13BDS2100X11BEE2100X15BES2100X15BEU2100X15BFR2100X14BFX2100X15BIA2100X15BIN2100X15BIN2100X19IT2100X21BJP2100X16BLA2100X15BND2100X15BRDE2100X13BSP2100X26B
- Lot codes and dates
Software version numbers 1.02.01.001.03.05.001.03.07.001.04.02.001.04.061.05.01and 1.06.02
- Amount recalled
- 101 (FEMA Stockpile Only); 21077 (OUS)
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
- Nationwide
Why it was 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).
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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