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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Device
Medical Devices/Home Healthcare

Philips Trilogy, Aeris, and LifeVent Ventilators Recalled for Flow Inaccuracy

Agency Publication Date: November 13, 2024
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Summary

Philips Respironics, Inc. has recalled approximately 154,564 ventilators, including Trilogy Evo, EV300, Aeris EVO, Garbin Evo, and LifeVent EVO2 models. These devices are used for breathing support in children and adults across hospital and home settings. The recall was initiated because using a medication-spraying device called a nebulizer in certain positions can cause medicine to build up on the internal sensor, leading to incorrect air flow measurements. No injuries have been reported at this time.

Risk

If the internal sensor provides inaccurate flow readings, the ventilator may not deliver the correct amount of air to the patient. This could lead to breathing difficulties or other serious health complications for patients who depend on the device.

What You Should Do

  1. The recalled products include several Philips ventilator models: Trilogy Evo, Trilogy Evo O2, Trilogy Evo Universal, Trilogy EV300, Aeris EVO, Garbin Evo, and LifeVent EVO2.
  2. To identify if your device is affected, look for the model number and UDI-DI number printed on the device label. There are dozens of affected model numbers including DS2110X11B, DS2200X11B, VT2110X24B, and SP2100X26B. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled ventilator and switch to a backup device if available.
  4. Contact your healthcare provider, medical equipment company, or Philips Respironics, Inc. immediately to arrange for a replacement device or to receive instructions on correcting the current device.
  5. If you or a patient are experiencing health concerns related to the ventilator's performance, contact a healthcare professional or emergency services immediately.
  6. Call the FDA Consumer Complaint hotline at 1-888-463-6332 for more information.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider, or return the product to the place of purchase for a refund or replacement
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Stop using and throw the product away.

Affected Products

Product: Trilogy Evo O2
Variants: Pediatric through adult patients (at least 2.5 kg)
Model / REF:
FP2100X10
DS2100X11B
IN2100X15B
DE2100X13B
IA2100X15B
EU2100X15B
LA2100X15B
EE2100X15B
FX2100X15B
ES2100X15B
ND2100X15B
FR2100X14B
IT2100X21B
JP2100X16B
IN2100X19
EU2100X19
Serial Numbers:
All Serial Numbers
UDI:
606959054103
606959051997
606959055698
606959054097
606959055674
606959055681
606959062085
606959055643
606959061019
606959055636
606959054059
606959055575
606959055438
606959055582
606959055599
606959055650

Recall #: Z-0290-2025; Quantity: 24,249 units

Product: Trilogy Evo
Variants: Pediatric through adult patients (at least 2.5 kg)
Model / REF:
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
Serial Numbers:
All Serial Numbers
UDI:
606959051980
606959055520
606959055476
606959052307
606959054110
606959051942
606959055544
606959054080
606959054981
606959055537
606959062092
606959055506
606959054127
606959055490
606959051959
606959055421
606959051973
606959055483
606959055452
606959055513
606959054035
606959060517
606959055551
606959060500

Recall #: Z-0291-2025; Quantity: 82,800 units

Product: Trilogy Evo Universal Ventilator
Variants: Pediatric through adult patients (at least 2.5 kg)
Model / REF:
DS2000X11B
Serial Numbers:
All Serial Numbers
UDI:
606959052000

Recall #: Z-0292-2025; Quantity: 9,999 units

Product: Trilogy EV300
Variants: Pediatric through adult patients (at least 2.5 kg)
Model / REF:
DS2200X11B
IN2200X15B
BL2200X15B
BR2200X18B
CA2200X12B
DE2200X13B
GB2200X15B
ND2200X15B
ES2200X15B
FR2200X14B
FX2200X15B
EU2200X15B
IA2200X15B
IT2200X21B
KR2200X15B
TR2200X15B
EE2200X15B
Serial Numbers:
All Serial Numbers
UDI:
606959052017
606959056497
606959058668
606959058583
606959052321
606959058651
606959058675
606959058620
606959058644
606959058613
606959061033
606959058682
606959058606
606959058637
606959058590
606959058798
606959058705

Recall #: Z-0293-2025; Quantity: 34,146 units

Product: Aeris EVO
Variants: Pediatric through adult patients (at least 2.5 kg)
Model / REF:
VT2110X24B
Serial Numbers:
All Serial Numbers
UDI:
606959062962

Recall #: Z-0294-2025; Quantity: 804 units

Product: Garbin Evo
Variants: Pediatric through adult patients (at least 2.5 kg)
Model / REF:
LD2110X23B
Serial Numbers:
All Serial Numbers
UDI:
606959057432

Recall #: Z-0295-2025; Quantity: 1,322 units

Product: LifeVent EVO2
Variants: Pediatric through adult patients (at least 2.5 kg)
Model / REF:
SP2100X26B
Serial Numbers:
All Serial Numbers
UDI:
606959057456

Recall #: Z-0296-2025; Quantity: 1,244 units

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95486
Status: Active
Manufacturer: Philips Respironics, Inc.
Sold By: Authorized Medical Distributors; Hospitals; Home Healthcare Providers
Manufactured In: United States
Units Affected: 7 products (24,249 units; 82,800 units; 9,999 units; 34,146 units; 804 units; 1,322 units; 1,244 units)
Distributed To: Nationwide
Agency Last Updated: December 30, 2024

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.

Find an Attorney

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 FDA Press Release 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.