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Unrated Medical device recall · FDA · Published July 26, 2021

Philips Respironics Trilogy Evo Universal: Software issues may cause pressure increase

Philips Respironics recalls Trilogy Evo Universal devices with specific software versions due to potential pressure increases in infants and children. Affected units may require software updates to prevent risks.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2290-2021Medical devicePhilips Respironics ›
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Contact the company

Recalling firmPhilips Respironics, Inc.1001 Murry Ridge Ln · Murrysville, PA 15668-8517
✎ GovInfoNow plain-language explainer

Philips Respironics is recalling Trilogy Evo Universal devices with certain software versions because they may cause pressure increases in infants and children. This could lead to health risks if the device malfunctions. Read more at govinfonow.com/recall/62150-philips-respironics-trilogy-evo-universal-software-issues-may-cause-pressure.

Source Summary by GovInfoNow · govinfonow.com/recall/62150-philips-respironics-trilogy-evo-universal-software-issues-may-cause-pressure · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2290-2021

Cite this page

“Philips Respironics Trilogy Evo Universal: Software issues may cause pressure increase.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62150-philips-respironics-trilogy-evo-universal-software-issues-may-cause-pressure. Based on FDA recall #Z-2290-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2290-2021%22&limit=1).

The FDA announced on July 26, 2021, that Philips Respironics is recalling the Trilogy Evo Universal (product number DS2000X11B) due to software issues causing pressure increases. The recall affects 10,000 units distributed worldwide and within the United States.

How to tell if you have it

  • Brand: Philips Respironics
  • Product: Trilogy Evo Universal
  • Product number: DS2000X11B
  • Software versions: 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
  • Quantity: 10,000 units (FEMA Stockpile Only)

The hazard

Two software issues have been identified related to pressure increase in the device: the "Infant/Pediatric EFS Calibration Pressure Increase" and "Pressure Drift (Continuous Usage)."

Context

GovInfoNow's records show Philips Respironics has issued 25 other recalls since June 12, 2018. Recent similar recalls include the Philips Respironics Trilogy Evo Ventilator Software Issue regarding obstruction alarms and the Philips Respironics Trilogy EV300 Ventilator Software Issue regarding tidal volume discrepancies, both on March 2, 2026. Other recent recalls of similar products include the Olympus UHI-3 Insufflation Unit Recall (Jan. 16, 2026), the Olympus UHI Insufflation Unit Recall (Jan. 16, 2026), and the Olympus UHI-2 Insufflation Unit Recall (Jan. 16, 2026).

How to tell if you have this one

Check the product number DS2000X11B and software versions 1.02.01.00, 1.03.05.00, 1.03.07.00, 1.04.02.00, 1.04.06, 1.05.01, or 1.06.02. The device is sold by Philips Respironics.

  • Brand
    Philips Respironics
  • Category
    Medical device
FDA recall event · 4 products

All 4 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Ongoing
  • Distribution
    Worldwide distribution - US nationwide distribution.
Recall numberProduct, codes & lotsQuantity
Z-2287-2021Trilogy Evo, Product numbers BL2110X15B, CA2110X12B, DE2110X13B, DS2110X11B, EE2110X15B, ES2110X15B, EU2110X15B, EU2110X19, FR2110X14B, GB2110X15B, IA2110X15B, IN2110X15B, IN2110X19, IT2110X21B, KR2110X15B, LA2110X15B, LD2110X23B, ND2110X15B, RDE2110X13B, UDS2110X11B; 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 1.06.0218588 (US); 5662 (OUS)
Z-2288-2021Trilogy Evo O2, Product numbers DE2100X13B, DS2100X11B, EE2100X15B, ES2100X15B, EU2100X15B, FR2100X14B, FX2100X15B, IA2100X15B, IN2100X15B, IN2100X19, IT2100X21B, JP2100X16B, LA2100X15B, ND2100X15B, RDE2100X13B, SP2100X26B; 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 1.06.02101 (FEMA Stockpile Only); 21077 (OUS)
Z-2289-2021Trilogy EV300, Product numbers CA2200X12B, DS2200X11B, FX2200X15B, IN2200X15B; 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 1.06.0218936 (US); 4659 (OUS)
Z-2290-2021Trilogy Evo Universal, Product number DS2000X11B; 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 1.06.0210,000 (FEMA Stockpile Only)
Based on the official FDA remedy

What to do — step by step

  1. Check Software Version

    Review the software version on your device to see if it matches the listed versions: 1.02.01.00, 1.03.05.00, 1.03.07.00, 1.04.02.00, 1.04.06, 1.05.01, or 1.06.02.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “Worldwide distribution - US nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 30 days after the firm started it.

1. Firm started the recall: Jul 26, 202112. FDA classified it Class II: Aug 13, 202123. Published in FDA’s Enforcement Report: Aug 25, 202132021
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

Similar recalls

Philips Respironics Trilogy Evo Ventilator Software Issue: Tidal Volume Discrepancy Risk
Philips RespironicsPhilips Respironics Trilogy Evo Ventilator Software Update Recalled for Safety
Philips RespironicsPhilips Respironics Trilogy Evo Ventilator Recall: Inaccurate Flow Measurements Risk
Philips RespironicsPhilips Respironics Trilogy Evo Ventilator Recall: Battery Alarm May Cause Sudden
Philips RespironicsPhilips Respironics Trilogy Evo O2 Ventilator Software Issue: Obstruction Alarm May Fail
Philips Respironics

Other Philips Respironics recalls

Philips Respironics, Inc. recalls DreamStation Auto BiPAP. Non-Continuous Ventilator.
June 30, 2025Philips Respironics, Inc. recalls BiPAP A40 Ventilator. Used to provide noninvasive ventilation support for the purpose of treating adult and pediatric
May 9, 2025Philips Respironics, Inc. recalls BiPAP V30 Auto Ventilator, Part Number 1111178
March 26, 2024Philips Respironics, Inc. recalls Trilogy Evo O2 EV300, Model Numbers DS2200X11B, IN2200X15B, FX2200X15B, CA2200X12B, FR2200X14B, ND2200X15B, ES2200X15B,
May 1, 2023Philips Respironics, Inc. recalls Trilogy EV300 Portable Electric Ventilator, Model Numbers DS2200X11B, IN2200X15B, FX2200X15B, CA2200X12B, CN2200X17B,
March 1, 2023Philips Respironics, Inc. recalls Philips DreamStation Auto BiPAP and CPAP, Model Numbers UCDSX500S11, UDSX500S11, UDSX500S11F, UDSX700S11, UDSX700S11F,
February 10, 2023

Keep exploring

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-2290-2021 (July 26, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2290-2021 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA