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High RiskFDA Device
Medical Devices/Home Healthcare

Philips Respironics, Inc.: Trilogy Evo Ventilators Recalled for Missing Safety Contraindications

Agency Publication Date: January 4, 2024
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Summary

Philips Respironics is recalling 100,126 Trilogy Evo and Trilogy Evo O2 ventilators because the safety labeling failed to include critical instructions regarding patient weight and use. Specifically, the AVAPS-AE therapy mode must not be used on patients weighing less than 22 pounds (10 kg) or for invasive treatments, and the standard AVAPS feature is also unsafe for patients under 22 pounds. Approximately 54,691 of these affected units were distributed across the United States and Puerto Rico.

Risk

If these ventilators are used on patients weighing less than 10 kg, it can cause severe lung injury from excessive pressure, insufficient breathing (hypoventilation), or the dangerous buildup and rebreathing of carbon dioxide.

What You Should Do

  1. Check your device to see if it is a Trilogy Evo or Trilogy Evo O2 model by looking for the product name on the front of the ventilator.
  2. Locate the Material Number and UDI-DI/GTIN barcode on the device label and compare it against the affected list, which includes numbers like BL2110X15B (606959055520), BR2110X18B (606959055476), and CA2110X12B (606959052307).
  3. Ensure the device is NOT being used in AVAPS or AVAPS-AE mode for any patient weighing less than 10 kg (22 lbs).
  4. Ensure the AVAPS-AE therapy mode is NOT being used for invasive ventilation (such as through a tracheostomy).
  5. Contact your healthcare provider or Philips Respironics immediately for updated safety labeling or further instructions regarding your device settings.
  6. For additional questions, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Label correction for safety contraindications.

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Trilogy Evo and Trilogy Evo O2 Ventilators
Model / REF:
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
UPC Codes:
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

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93609
Status: Active
Manufacturer: Philips Respironics, Inc.
Sold By: Authorized medical distributors; Healthcare facilities
Manufactured In: United States
Units Affected: 100,126 (54,691 US; 45,435 OUS) in total
Distributed To: Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia, Wyoming

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.