The Recall Desk
Agency classClass IOur severity:CriticalFDA (Devices)·Z-1650-2023·Announced 2023-06-14

Philips Trilogy and LifeVent ventilator models recalled for flow sensor debris

Environmental debris accumulation may block flow sensors in Philips ventilators, potentially preventing accurate pressure and flow delivery to patients.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 5/5 (Critical).

Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.

Our severity reasoning: FDA Class I medical device classification indicates significant risk of serious adverse health consequences. The malfunction could prevent accurate oxygen delivery, potentially causing hypoxemia in patients dependent on these life-support devices.

Plain-English summary

Philips Respironics has recalled certain Trilogy Evo O2 and LifeVent EVO2 ventilator models due to a potential malfunction of the internal flow sensor. The recall affects approximately 21,520 devices with distribution spanning the United States and other countries.

Environmental debris can accumulate on the internal machine flow sensor, causing partial occlusion. This blockage may prevent accurate delivery of pressure, volume, or flow to patients dependent on the ventilator for respiratory support.

When the flow sensor becomes partially obstructed, the device cannot function reliably. The malfunction can result in patient harm, up to and including hypoxemia, if not addressed by the care provider. Hypoxemia is a condition of abnormally low oxygen in the blood that requires immediate medical attention.

Users of the affected ventilator models should take appropriate action to address this issue. Contact with Philips Respironics or a healthcare provider is recommended to determine whether the device needs inspection, maintenance, or replacement.

The recalled product

Product
Trilogy Evo O2 and LifeVent EVO2, Model Numbers DS2100X11B, IN2100X15B, IN2100X19, FX2100X15B, LA2100X15B, IA2100X15B, FP2100X10, FR2100X14B, ND2100X15B, IT2100X21B, ES2100X15B, DE2100X13B, EU2100X15B, EU2100X19, EE2100X15B, and SP2100X26B
Manufacturer
Philips Respironics, Inc.
Category
Medical Device — Ventilator/Respiratory Equipment
Hazard
Affected units
21,520

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 recalled by Philips Respironics, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

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