Reported Aug 25, 2021 · Ongoing

Trilogy Evo Universal, Product number DS2000X11B

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 Universal, Product number DS2000X11B
Lot codes and dates
    • Software version numbers 1.02.01.00
    • 1.03.05.00
    • 1.03.07.00
    • 1.04.02.00
    • 1.04.06
    • 1.05.01
    • and 1.06.02
Amount recalled
10,000 (FEMA Stockpile Only)

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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:57 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.