🔍 RecallPedia

Trilogy EV300, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients.

Class I - Dangerous
🏥 Medical Devices Recalled: March 19, 2024 Philips Respironics Patient Monitors Nationwide

What Should You Do?

  1. Check if you have this product:
    Model No. BL2200X15B, BR2200X18B, CA2200X12B, EE2200X15B, EU2100X15B, EU2100X19, EU2200X15B, FR2200X14B, DE2200X13B, GB2200X15B, FX2100X15B, FX2200X15B, IN2100X15B, IN2100X19, IN2200X15B, IT2200X21B, JP2100X16B, KR2200X15B, LA2100X15B, ND2200X15B, ES2200X15B, TR2200X15B, DS2100X11B, DS2200X11B, UDI-DI: 606959058668, 606959058583, 606959052321, 606959058705, 606959055674, 606959055681, 606959058682, 606959058613, 606959058651, 606959058675, 606959061019, 606959061033, 606959054059, 606959055575, 606959056497, 606959058637, 606959055582, 606959058590, 606959055599, 606959058620, 606959058644, 606959058798, 606959051997, 606959052017; All units except those with software version 1.05.06.00.
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Philips Respironics, Inc.
Reason for Recall:
Potential for sudden loss of ventilation due to Battery Depleted or Loss of Power alarm while unit has sufficient power.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

Trilogy EV300, all software versions except 1.05.06.00. Ventilator for pediatric and adult patients.

Product Codes/Lot Numbers:

Model No. BL2200X15B, BR2200X18B, CA2200X12B, EE2200X15B, EU2100X15B, EU2100X19, EU2200X15B, FR2200X14B, DE2200X13B, GB2200X15B, FX2100X15B, FX2200X15B, IN2100X15B, IN2100X19, IN2200X15B, IT2200X21B, JP2100X16B, KR2200X15B, LA2100X15B, ND2200X15B, ES2200X15B, TR2200X15B, DS2100X11B, DS2200X11B, UDI-DI: 606959058668, 606959058583, 606959052321, 606959058705, 606959055674, 606959055681, 606959058682, 606959058613, 606959058651, 606959058675, 606959061019, 606959061033, 606959054059, 606959055575, 606959056497, 606959058637, 606959055582, 606959058590, 606959055599, 606959058620, 606959058644, 606959058798, 606959051997, 606959052017; All units except those with software version 1.05.06.00.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1502-2024

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