Reported Aug 25, 2021 · Ongoing
Trilogy Evo, Product numbers BL2110X15B, CA2110X12B, DE2110X13B, DS2110X11B, EE2110X15B, ES2110X15B, EU2110X15B,…
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 EvoProduct numbers BL2110X15BCA2110X12BDE2110X13BDS2110X11BEE2110X15BES2110X15BEU2110X15BEU2110X19FR2110X14BGB2110X15BIA2110X15BIN2110X15BIN2110X19IT2110X21BKR2110X15BLA2110X15BLD2110X23BND2110X15BRDE2110X13BUDS2110X11B
- 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
- 18588 (US); 5662 (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.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new infant & baby recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.