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FDAMarch 1, 2023device

Trilogy Evo Universal Portable Electric Ventilator, Model Number DS2000X11B

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Ongoing

Brands named

philips respironicsphilips

UPCs

606959052000

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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Trilogy Evo Universal Portable Electric Ventilator, Model Number DS2000X11B — Recall Details · AllClear