Reported Nov 20, 2024 · Ongoing
Trilogy Evo O2. Model Numbers: FP2100X10, DS2100X11B, IN2100X15B, DE2100X13B, IA2100X15B, EU2100X15B, LA2100X15B,…
Philips Respironics, Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.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 O2
- Model NumbersFP2100X10, DS2100X11B, IN2100X15B, DE2100X13B, IA2100X15B, EU2100X15B, LA2100X15B, EE2100X15B, FX2100X15B, ES2100X15B, ND2100X15B, FR2100X14B, IT2100X21B, JP2100X16B, IN2100X19, EU2100X19. Intended for invasive and non-invasive ventilation of pediatric through adult patients weighing at least 2.5 kg in institutional, home, and non-emergency transport settings
- Lot codes and dates
16 of 16 products
Products covered by this recall # Barcodes Product as published 1 606959054103Model Number (UDI-DI Number): DE2100X13B (606959054103) 2 606959051997DS2100X11B (606959051997) 3 606959055698EE2100X15B (606959055698) 4 606959054097ES2100X15B (606959054097) 5 606959055674EU2100X15B (606959055674) 6 606959055681EU2100X19 (606959055681) 7 606959062085FP2100X10 (606959062085) 8 606959055643FR2100X14B (606959055643) 9 606959061019FX2100X15B (606959061019) 10 606959055636IA2100X15B (606959055636) 11 606959054059IN2100X15B (606959054059) 12 606959055575IN2100X19 (606959055575) 13 606959055438IT2100X21B (606959055438) 14 606959055582JP2100X16B (606959055582) 15 606959055599LA2100X15B (606959055599) 16 606959055650ND2100X15B (606959055650). All Serial Numbers. - Amount recalled
- 24,249 units
This recall covers 7 products
The agency filed one notice per product. You are reading one of them; the other 6 are below.
Where it was sold
Why it was recalled
Stop using this product now
Potential for in-line nebulizer configuration in certain locations to result in aerosol deposit accumulation on the device's internal flow sensor, which could lead to inaccurate flow measurements.
Using this product could cause serious injury, illness or death — stop using it now.
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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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