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.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. 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.
- 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 →Related recalls
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Same hazard · environmental debris
See all →- SeverePhilips Respironics Ventilators Recalled for Flow Sensor Debris Accumulation
FDA (Devices) · 2023-06-14