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Lower risk Medical device recall · FDA · Published October 7, 2024

Philips Respironics Trilogy Evo Ventilator Recall: Inaccurate Flow Measurements Risk

Philips Respironics recalls Trilogy Evo Universal Ventilators (model DS2000X11B) due to potential inaccurate flow measurements from aerosol deposits. Affected units may require servicing to prevent incorrect ventilation readings.

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

🇺🇸 FDA recall #Z-0292-2025Medical 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 its Trilogy Evo Universal Ventilators (model DS2000X11B) because aerosol deposits can cause inaccurate flow measurements. This could lead to improper ventilation settings for patients, especially in critical care situations. Read more at govinfonow.com/recall/53784-philips-respironics-trilogy-evo-ventilator-recall-inaccurate-flow-measurements-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/53784-philips-respironics-trilogy-evo-ventilator-recall-inaccurate-flow-measurements-risk · Updated August 18, 2026 · FDA enforcement record: FDA #Z-0292-2025

Cite this page

“Philips Respironics Trilogy Evo Ventilator Recall: Inaccurate Flow Measurements Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/53784-philips-respironics-trilogy-evo-ventilator-recall-inaccurate-flow-measurements-risk. Based on FDA recall #Z-0292-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0292-2025%22&limit=1).

Philips Respironics, Inc. voluntarily recalled the Trilogy Evo Universal Ventilator (Model DS2000X11B) on Oct. 7, 2024, according to the FDA. The device poses a hazard of inaccurate flow measurements due to aerosol accumulation on the internal flow sensor.

How to tell if you have it

  • Brand: Philips Respironics
  • Product: Trilogy Evo Universal Ventilator
  • Model Number: DS2000X11B
  • UDI-DI Number: 606959052000
  • Serial Numbers: All Serial Numbers
  • Quantity: 9,999 units

The hazard

The recall cites a potential for in-line nebulizer configuration to cause aerosol deposit accumulation on the device's internal flow sensor, leading to inaccurate flow measurements. FDA MAUDE database records show 11 reports naming the Trilogy Evo since October 2023, including 8 serious incidents and 2 deaths.

Context

GovInfoNow's records show Philips Respironics has issued 25 other recalls since June 12, 2018. Recent brand recalls include the March 2, 2026 Trilogy Evo obstruction alarm failure and the March 2, 2026 Trilogy EV300 tidal volume discrepancy risk. Other recent recalls of similar products include the Ventec V+Pro Ventilator Recall (March 25, 2026) and the Olympus UHI-4 Insufflation Unit Recall (June 16, 2026).

How to tell if you have this one

The Trilogy Evo Universal Ventilator with model number DS2000X11B. All units sold with serial numbers are affected. This device is used for medical ventilation in institutional, home, and non-emergency transport settings.

  • Brand
    Philips Respironics
  • Category
    Medical device
FDA recall event · 7 products

All 7 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 I
  • Status
    Ongoing
  • Distribution
    Worldwide distribution - US Nationwide and the countries of AE, AF, AR, AT, AU, BD, BE, BG, BH, BO, BR, BS, CA, CH, CL, CN, CO, CZ, DE, DK, DZ, EC, EE, EG, ES, FI, FR, GB, GE, GF, GI, GR, GT, HK, HR, HU, ID, IE, IL, IN, IT, JE, JO, JP, KE, KR, KW, LB, LT, LY, MA, ME, MK, MM, MQ, MT, MX, MY, NG, NL, NO, NP, NZ, OM, PA, PE, PF, PH, PK, PL, PT, PY, QA, RE, RO, RS, RU, SA, SE, SG, SI, SK, TH, TN, TR, TW, TZ, UA, UY, VN, YT, ZA, ZW.
Recall numberProduct, codes & lotsQuantity
Z-0290-2025Trilogy Evo O2. Model Numbers: FP2100X10, 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.; Model Number (UDI-DI Number): DE2100X13B (606959054103); DS2100X11B (606959051997); EE2100X15B (606959055698); ES2100X15B (606959054097); EU2100X15B (606959055674); EU2100X19 (606959055681); FP2100X10 (606959062085); FR2100X14B (606959055643); FX2100X15B (606959061019); IA2100X15B (606959055636); IN2100X15B (606959054059); IN2100X19 (606959055575); IT2100X21B (606959055438); JP2100X16B (606959055582); LA2100X15B (606959055599); ND2100X15B (606959055650). All Serial Numbers.24,249 units
Z-0291-2025Trilogy Evo. Model Numbers: DS2110X11B, UDS2110X11B, RDS2110X11B, CA2110X12B, JP2110X16B, IN2110X15B, DE2110X13B, AU2110X15B, BL2110X15B, EU2110X15B, BR2110X18B, LA2110X15B, EE2110X15B, FR2110X14B, GB2110X15B, ND2110X15B, ES2110X15B, IA2110X15B, IT2110X21B, KR2110X15B, TR2110X15B, EU2110X19, FP2110X10, PP2110X10, RBRBR2110X18B. 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.; Model Number (UDI-DI Number): AU2110X15B (606959051980); BL2110X15B (606959055520); BR2110X18B (606959055476); CA2110X12B (606959052307); DE2110X13B (606959054110); DS2110X11B (606959051942); EE2110X15B (606959055544); ES2110X15B (606959054080); EU2110X15B (606959054981); EU2110X19 (606959055537); FP2110X10 (606959062092); FR2110X14B (606959055506); GB2110X15B (606959054127); IA2110X15B (606959055490); IN2110X15B (606959051959); IT2110X21B (606959055421); JP2110X16B (606959051973); KR2110X15B (606959055483); LA2110X15B (606959055452); ND2110X15B (606959055513); PP2110X10 (606959054035); RBRBR2110X18B (606959055476); RDS2110X11B (606959060517); TR2110X15B (606959055551); UDS2110X11B (606959060500). All Serial Numbers.82,800 units
Z-0292-2025Trilogy Evo Universal Ventilator. Model Number DS2000X11B. 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.; Model Number DS2000X11B, UDI-DI Number: 606959052000. All Serial Numbers.9,999 units
Z-0293-2025Trilogy EV300. Model Numbers: DS2200X11B, IN2200X15B, BL2200X15B, BR2200X18B, CA2200X12B, DE2200X13B, GB2200X15B, ND2200X15B, ES2200X15B, FR2200X14B, FX2200X15B, EU2200X15B, IA2200X15B, IT2200X21B, KR2200X15B, TR2200X15B, EE2200X15B. 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.; Model Number (UDI-DI Number): DS2200X11B (606959052017); IN2200X15B (606959056497); BL2200X15B (606959058668); BR2200X18B (606959058583); CA2200X12B (606959052321); DE2200X13B (606959058651); GB2200X15B (606959058675); ND2200X15B (606959058620); ES2200X15B (606959058644); FR2200X14B (606959058613); FX2200X15B (606959061033); EU2200X15B (606959058682); IA2200X15B (606959058606); IT2200X21B (606959058637); KR2200X15B (606959058590); TR2200X15B (606959058798); EE2200X15B (606959058705). All Serial Numbers.34,146 units
Z-0294-2025Aeris EVO. Model Number: VT2110X24B. 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.; Model Number: VT2110X24B, UDI-DI Number: 606959062962. All Serial Numbers.804 units
Z-0295-2025Garbin Evo. Model Number: LD2110X23B. 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.; Model No. LD2110X23B; UDI-DI: 606959057432; All Serial Numbers.1,322 units
Z-0296-2025LifeVent EVO2. Model Number: SP2100X26B. 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.; Model No. SP2100X26B; UDI-DI: 606959057456; All Serial Numbers.1,244 units
Based on the official FDA remedy

What to do — step by step

  1. Check Device Model

    Verify the model number on your ventilator; affected units have DS2000X11B.

  2. Contact Manufacturer

    Reach out to Philips Respironics for guidance on next steps.

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 and the countries of AE, AF, AR, AT, AU, BD, BE, BG, BH, BO, BR, BS, CA, CH, CL, CN, CO, CZ, DE, DK, DZ, EC, EE, EG, ES, FI, FR, GB, GE, GF, GI, GR, GT, HK, HR, HU, ID, IE, IL, IN, IT, JE, JO, JP, KE,…” 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 44 days after the firm started it.

1. Firm started the recall: Oct 7, 202412. FDA classified it Class I: Nov 13, 202423. Published in FDA’s Enforcement Report: Nov 20, 202432024
  1. Firm started the recall
  2. FDA classified it Class I
  3. Published in FDA’s Enforcement Report

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

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Is there a risk of serious injury?

The recall addresses potential inaccurate flow measurements, not immediate injury risks. The hazard level is low risk.

Similar recalls

Philips Respironics Trilogy Evo Ventilator Software Issue: Tidal Volume Discrepancy Risk
Philips RespironicsPhilips Respironics Trilogy EV300 Portable Ventilator: Oxygen Delivery Inaccurate
Philips RespironicsPhilips Respironics Trilogy Evo Ventilator Recall: Non-conforming foam may cause
Philips RespironicsPhilips Respironics E30 Ventilator Recall: Foam Particles Risk
Philips RespironicsPhilips Respironics Trilogy Evo Ventilator Recall: Battery Alarm May Cause Sudden
Philips Respironics

Other Philips Respironics recalls

Philips Respironics, Inc. recalls Philips Respironics Trilogy Evo O2, Software Version 1.05.15.00. Continuous home-use ventilator device.
March 2, 2026Philips 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 Trilogy Evo; Model No./Model Description -- AU2110X15B Trilogy Evo, Australia BL2110X15B Trilogy Evo, Benelux
July 16, 2024Philips 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, 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-0292-2025 (October 7, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0292-2025 to see it in context.
  • Plain-language summary written by qwen3:4b on August 18, 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