The Recall Desk

FDA (Devices) recall action 91832

Philips Respironics, Inc. recalled 3 products on 2023-04-12

The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.

Products
3
Announced
2023-04-12
Critical
0
Units
188,478

Why these products were recalled

The accuracy of delivered oxygen may deviate below the required tolerance of 5% from setpoint when providing high concentration oxygen therapy. Additionally, if equipped, the internal FiO2 sensor may indicate a value higher than the device is actually delivering. This may lead to under delivery of oxygen.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–3 of 3

  • SevereFDA (Devices)··2023-04-12

    Trilogy EV300 Portable Electric Ventilator may deliver insufficient oxygen

    The Trilogy EV300 Portable Electric Ventilator may deliver insufficient oxygen during high-concentration therapy due to accuracy deviations. The device's internal oxygen sensor may also display incorrect readings, creating a risk of oxygen under-delivery to patients.

    Product
    Trilogy EV300 Portable Electric Ventilator, Model Numbers DS2200X11B, IN2200X15B, FX2200X15B, CA2200X12B, CN2200X17B, BR2200X18B, KR2200X15B, IA2200X15B, FR2200X14B, ND2200X15B, IT2200X21B, ES2200X15B, DE2200X13B, BL2200X15B, GB2200X15B, EU2200X15B, EU2200X19, EE2200X15B, TR2200X
    Category
    Distribution
    8 states
  • SevereFDA (Devices)··2023-04-12

    Philips Trilogy Evo Portable Ventilators Recalled for Inaccurate Oxygen Delivery

    Philips Respironics is recalling the Trilogy Evo Universal Portable Electric Ventilator (Model DS2000X11B) because it may deliver oxygen below the prescribed level during high-concentration oxygen therapy, potentially depriving patients of adequate oxygen.

    Product
    Trilogy Evo Universal Portable Electric Ventilator, Model Number DS2000X11B
    Category
    Distribution
    8 states
  • SevereFDA (Devices)··2023-04-12

    Portable Electric Ventilators May Deliver Insufficient Oxygen During High-Concentration Therapy

    Philips Respironics ventilators may deliver oxygen below required tolerance during high-concentration therapy. The FiO2 sensor may display higher readings than actual delivery, risking insufficient oxygen to patients.

    Product
    Trilogy Evo O2 and LifeVentEVO2 Portable Electric Ventilator, Model Numbers DS2100X11B, IN2100X15B, IN2100X19, FX2100X15B, JP2100X16B, AU2100X15B, LA2100X15B, CA2100X12B, CN2100X17B, BR2100X18B, KR2100X15B, IA2100X15B, PP2100X10, FP2100X10, FR2100X14B, ND2100X15B, IT2100X21B, ES2
    Category
    Distribution
    8 states