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Use caution Medical device recall · FDA · Published November 27, 2023

Philips Respironics Trilogy Evo O2: Avoid using on patients under 10 kg due to safety risk

Philips Respironics recalls Trilogy Evo and Trilogy Evo O2 devices with specific material numbers. These devices may cause barotrauma or breathing issues if used on patients under 10 kg due to missing contraindications in the safety statement.

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

🇺🇸 FDA recall #Z-0638-2024Medical 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 certain Trilogy Evo and Trilogy Evo O2 devices because they lack a critical safety warning about using them on patients under 10 kg. This could lead to serious breathing problems or injury if the device is used incorrectly on small patients. Read more at govinfonow.com/recall/56769-philips-respironics-trilogy-evo-o2-avoid-using-on-patients-under.

Source Summary by GovInfoNow · govinfonow.com/recall/56769-philips-respironics-trilogy-evo-o2-avoid-using-on-patients-under · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0638-2024

Cite this page

“Philips Respironics Trilogy Evo O2: Avoid using on patients under 10 kg due to safety risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/56769-philips-respironics-trilogy-evo-o2-avoid-using-on-patients-under. Based on FDA recall #Z-0638-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0638-2024%22&limit=1).

The FDA announced on Nov. 27, 2023, that Philips Respironics is recalling Trilogy Evo and Trilogy Evo O2 devices due to missing contraindications for the AVAPS-AE therapy mode. The agency said the omission could lead to barotrauma or hypoventilation in patients under 10 kg.

How to tell if you have it

  • Brand: Philips Respironics
  • Product: Trilogy Evo and Trilogy Evo O2
  • Material Numbers: BL2110X15B, BR2110X18B, CA2110X12B, DE2100X13B, DE2110X13B, DS2100X11B, DS2110X11B, EE2100X15B, EE2110X15B, ES2100X15B, ES2110X15B, EU2100X15B, EU2100X19, EU2110X15B, FR2100X14B, FR2110X14B, FX2100X15B, GB2110X15B, IA2100X15B, IA2110X15B, IN2100X15B, IN2100X19, IN2110X15B, IT2100X21B, IT2110X21B, JP2100X16B, JP2110X16B, KR2110X15B, LA2100X15B, LA2110X15B, ND2110X15B, RDE2100X13B, RDE2110X13B, RDS2110X11B, RIN2100X15B, RIN2110X15B, RJP2100X16B, RJP2110X16B, UDS2110X11B
  • UPCs: 606959055520, 606959055476, 606959052307, 606959054103, 606959054110, 606959051997, 606959051942, 606959055698, 606959055544, 606959054097, 606959054080, 606959055674, 606959055681, 606959054981, 606959055643, 606959055506, 606959061019, 606959054127, 606959055636, 606959055490, 606959054059, 606959055575, 606959051959, 606959055438, 606959055421, 606959055582, 606959051973, 606959055483, 606959055599, 606959055452, 606959055513, 606959060517, 606959060500
  • Units affected: 100,126 total (54,691 US; 45,435 OUS)

The hazard

According to the FDA, the Contraindications Statement for the AVAPS-AE therapy mode was missing warnings that it is contraindicated for invasive use and for patients less than 10 kg. The agency said potential harms from using the device on these contraindicated patients include barotrauma, hypoventilation/hypercapnia, and rebreathing of excessive CO2.

Context

GovInfoNow's records show Philips Respironics has had 25 other recalls since June 12, 2018. Recent brand recalls include a March 2, 2026 Trilogy Evo software issue where the obstruction alarm may fail and a March 2, 2026 Trilogy EV300 issue involving tidal volume discrepancies. Other recent recalls of similar products include a Dec. 15, 2025 Philips Allura Xper FD10C recall for electrical short-circuit risks, a Dec. 24, 2025 Medline Intubation Tray recall for airway obstruction risks, and a Dec. 15, 2025 Philips Allura Xper FD10F recall for electrical short-circuit risks.

How to tell if you have this one

Check the device's material numbers listed in the recall notice: BL2110X15B, BR2110X18B, CA2110X12B, DE2100X13B, DE2110X13B, DS2100X11B, and other specific codes. These models were sold in various countries with different serial numbers.

  • Brand
    Philips Respironics
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Device Model

    Identify the device's material number from the list provided in the recall notice to confirm if it is affected.

  2. Consult Healthcare Provider

    Talk to your healthcare provider to determine if the device is safe for your child's weight and medical needs.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 48 states.

Alaska: named in the noticeAKMaine: named in the noticeMEVermont: nationwideVTNew Hampshire: named in the noticeNHWashington: named in the noticeWAIdaho: named in the noticeIDMontana: named in the noticeMTNorth Dakota: named in the noticeNDMinnesota: named in the noticeMNIllinois: named in the noticeILWisconsin: named in the noticeWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: named in the noticeRIMassachusetts: named in the noticeMAOregon: named in the noticeORNevada: named in the noticeNVWyoming: named in the noticeWYSouth Dakota: named in the noticeSDIowa: named in the noticeIAIndiana: named in the noticeINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: named in the noticeCTCalifornia: named in the noticeCAUtah: named in the noticeUTColorado: named in the noticeCONebraska: named in the noticeNEMissouri: named in the noticeMOKentucky: named in the noticeKYWest Virginia: named in the noticeWVVirginia: named in the noticeVAMaryland: named in the noticeMDDelaware: named in the noticeDEArizona: named in the noticeAZNew Mexico: named in the noticeNMKansas: named in the noticeKSArkansas: named in the noticeARTennessee: named in the noticeTNNorth Carolina: named in the noticeNCSouth Carolina: named in the noticeSCDistrict of Columbia: nationwideDCOklahoma: named in the noticeOKLouisiana: named in the noticeLAMississippi: named in the noticeMSAlabama: named in the noticeALGeorgia: named in the noticeGAHawaii: nationwideHITexas: named in the noticeTXFlorida: named in the noticeFLPuerto Rico: named in the noticePR

FDA distribution: “Worldwide distribution: US (nationwide)-AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin, Wyoming.

Recall timeline

FDA published this recall 44 days after the firm started it.

1. Firm started the recall: Nov 27, 202312. FDA classified it Class II: Jan 4, 202423. Published in FDA’s Enforcement Report: Jan 10, 2024320232024
  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.

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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 Philips Respironics Trilogy Evo Universal, 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 Trilogy Evo; Model No./Model Description -- AU2110X15B Trilogy Evo, Australia BL2110X15B Trilogy Evo, Benelux
July 16, 2024Philips Respironics, Inc. recalls Trilogy Evo Universal Ventilator, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients.
March 19, 2024Philips Respironics, Inc. recalls Trilogy Evo O2 EV300, Model Numbers DS2200X11B, IN2200X15B, FX2200X15B, CA2200X12B, FR2200X14B, ND2200X15B, ES2200X15B,
May 1, 2023

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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-0638-2024 (November 27, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0638-2024 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