Reported Jan 10, 2024 · Ongoing
Trilogy Evo and Trilogy Evo O2 Material Numbers BL2110X15B BR2110X18B CA2110X12B DE2100X13B DE2110X13B DS2100X11B…
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 and Trilogy Evo O2 Material Numbers
BL2110X15BBR2110X18BCA2110X12BDE2100X13BDE2110X13BDS2100X11BDS2110X11BEE2100X15BEE2110X15BES2100X15BES2110X15BEU2100X15BEU2100X19EU2110X15BFR2100X14BFR2110X14BFX2100X15BGB2110X15BIA2100X15BIA2110X15BIN2100X15BIN2100X19IN2110X15BIT2100X21BIT2110X21BJP2100X16BJP2110X16BKR2110X15BLA2100X15BLA2110X15BND2110X15BRDE2100X13BRDE2110X13BRDS2110X11BRIN2100X15BRIN2110X15BRJP2100X16BRJP2110X16BUDS2110X11B
- Lot codes and dates
- Material UDI-DI/GTINAll units of listed models are affected by this correction.
72 of 72 codes
BL2110X15B606959055520BR2110X18B606959055476CA2110X12B606959052307DE2100X13B606959054103DE2110X13B606959054110DS2100X11B606959051997DS2110X11B606959051942EE2100X15B606959055698EE2110X15B606959055544ES2100X15B606959054097ES2110X15B606959054080EU2100X15B606959055674EU2100X19606959055681EU2110X15B606959054981FR2100X14B606959055643FR2110X14B606959055506FX2100X15B606959061019GB2110X15B606959054127IA2100X15B606959055636IA2110X15B606959055490IN2100X15B606959054059IN2100X19606959055575IN2110X15B606959051959IT2100X21B606959055438IT2110X21B606959055421JP2100X16B606959055582JP2110X16B606959051973KR2110X15B606959055483LA2100X15B606959055599LA2110X15B606959055452
- Material UDI-DI/GTIN
- Amount recalled
- 100,126 (54,691 US; 45,435 OUS) in total
Where it was sold
Why it was recalled
The following was missing from the Contraindications Statement: The AVAPS-AE therapy mode is contraindicated for invasive use and patients less than 10 kg. The AVAPS feature is contraindicated for patients less than 10 kg. Potential harms if devices are used on contraindicated patients include barotrauma, hypoventilation/hypercapnia, and rebreathing of excessive CO2.
This product could cause temporary or reversible health problems — stop using it.
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