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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 Respironics, Inc.: Trilogy and Garbin EVO Ventilators Recalled for Sudden Loss of Ventilation

Agency Publication Date: April 17, 2024
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Summary

Philips Respironics is recalling approximately 146,523 ventilators across several models, including the Trilogy Evo, Trilogy EV300, Garbin EVO, and Aeris EVO, due to a critical software defect. These life-support devices may trigger a false 'Battery Depleted' or 'Loss of Power' alarm even when they have sufficient power, leading to a sudden and unexpected stop in breathing assistance. This recall affects all software versions except version 1.05.06.00 for pediatric and adult patients across the globe. Philips is issuing a software update to correct this sensing error and prevent device shutdowns.

Risk

The defect causes the ventilator to stop delivering air to the patient without actual power loss, which can lead to serious injury or death from lack of oxygen. While no specific injury counts are listed in this data, the failure of a life-support device to provide ventilation is considered a critical risk to patient safety.

What You Should Do

  1. Check your ventilator's software version immediately; all versions are affected except for version 1.05.06.00.
  2. Verify your device against the model and serial numbers, including Trilogy Evo (models such as DS2110X11B, EU2110X15B), Trilogy EV300 (models like BL2200X15B, EU2100X15B), Garbin EVO (LD2110X23B), and Aeris EVO (VT2110X24B).
  3. Ensure the ventilator is always connected to a reliable AC (wall) power source whenever possible to reduce the risk of power-related false alarms.
  4. Always have an alternative ventilation method, such as a manual resuscitator or a backup ventilator, immediately available in case of a sudden device failure.
  5. Contact your home healthcare provider or Philips Respironics at 1-800-345-6443 to arrange for the mandatory software update to version 1.05.06.00.
  6. Healthcare providers and patients should visit the Philips website at www.philips.com/src-update for further technical instructions and safety notices.
  7. Contact your healthcare provider immediately if the patient experiences respiratory distress or if the device exhibits unusual alarm behavior.
  8. For additional questions, contact the FDA hotline at 1-888-463-6332 (1-888-INFO-FDA).

Your Remedy Options

You have 2 options:

๐Ÿ”งOption 1: Free Repair

Software update to version 1.05.06.00

How to: Contact your home healthcare provider or the manufacturer to receive the latest software update which fixes the alarm and power sensing issue.
๐Ÿ“‹Option 2: Other Action

Healthcare provider consultation

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

Affected Products

Product: Aeris EVO Ventilator (Pediatric and Adult)
Model / REF:
VT2110X24B
UPC Codes:
606959062962
Lot Numbers:
Serial numbers starting with H319, H320, H321, H322, H323, H324, H357, H358, H359, H800
Product: Garbin EVO Ventilator (Pediatric and Adult)
Model / REF:
LD2110X23B
UPC Codes:
606959057432
Lot Numbers:
Serial numbers starting with H247, H252, H261, H271, H298, H299, H319, H321, H322, H323, H327, H328, H357, H358, H800
Product: LifeVentEVO2 Ventilator (Pediatric and Adult)
Model / REF:
SP2100X26B
UPC Codes:
606959057456
Lot Numbers:
Serial numbers starting with H255, H256, H259, H260, H262, H263, H266, H272, H274, H275, H275, H800
Product: Trilogy EV300 Ventilator
Model / REF:
BL2200X15B
BR2200X18B
CA2200X12B
EE2200X15B
EU2100X15B
EU2100X19
EU2200X15B
FR2200X14B
DE2200X13B
GB2200X15B
FX2100X15B
FX2200X15B
IN2100X15B
IN2100X19
IN2200X15B
IT2200X21B
JP2100X16B
KR2200X15B
LA2100X15B
ND2200X15B
ES2200X15B
TR2200X15B
DS2100X11B
DS2200X11B
UPC Codes:
606959058668
606959058583
606959052321
606959058705
606959055674
606959055681
606959058682
606959058613
606959058651
606959058675
606959061019
606959061033
606959054059
606959055575
606959056497
606959058637
606959055582
606959058590
606959055599
606959058620
606959058644
606959058798
606959051997
606959052017
Lot Numbers:
All units except those with software version 1.05.06.00
Product: Trilogy Evo O2 Ventilator
Model / REF:
EE2100X15B
FR2100X14B
DE2100X13B
ES2100X15B
IA2100X15B
IT2100X21B
ND2100X15B
UPC Codes:
606959055698
606959055643
606959054103
606959054097
606959055636
606959055438
606959055650
Lot Numbers:
Serial numbers starting with H236, H237, H243, H247, H255, H257, H259, H260, H262, H263, H264, H269, H272, H274, H275, H800
Product: Trilogy Evo Ventilator
Model / REF (57):
AU2110X15B
BL2110X15B
BL2200X15B
BR2110X18B
BR2200X18B
CA2110X12B
CA2200X12B
DE2100X13B
DE2110X13B
DE2200X13B
DS2000X11B
DS2100X11B
DS2110X11B
DS2200X11B
EE2100X15B
EE2110X15B
EE2200X15B
ES2100X15B
ES2110X15B
ES2200X15B
EU2100X15B
EU2100X19
EU2110X15B
EU2110X19
EU2200X15B
FR2100X14B
FR2110X14B
FR2200X14B
FX2100X15B
FX2200X15B
GB2110X15B
GB2200X15B
IA2100X15B
IA2110X15B
IN2100X15B
IN2100X19
IN2110X15B
IN2200X15B
IT2100X21B
IT2110X21B
IT2200X21B
JP2100X16B
JP2110X16B
KR2110X15B
KR2200X15B
LA2100X15B
LA2110X15B
LD2110X23B
ND2100X15B
ND2110X15B
UPC Codes:
606959051980
606959055520
606959055476
606959052307
606959054110
606959051942
606959055544
606959054080
606959054981
606959055537
606959055506
606959054127
606959055490
606959051959
606959055421
606959051973
606959055483
606959055452
606959055513
606959060517
606959055551
606959060500
Lot Numbers:
All units except those with software version 1.05.06.00
Product: Trilogy Evo Universal Ventilator
Model / REF:
DS2000X11B
UPC Codes:
606959052000
Lot Numbers:
All units except those with software version 1.05.06.00

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94263
Status: Active
Manufacturer: Philips Respironics, Inc.
Sold By: Authorized Medical Device Distributors; Specialty Retailers; Direct Manufacturer Sales
Manufactured In: United States
Units Affected: 7 products (775 units; 1,233 units; 1,002 units; 56,012 units; 789 units; 76,713 units; 9,999 units)
Distributed To: Nationwide

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.