The Recall Desk
SevereFDA (Devices)·Z-0292-2025·Announced 2024-11-20

Trilogy Evo Universal Ventilator Recalled Due to Sensor Malfunction Risk

Trilogy Evo Universal Ventilators (Model DS2000X11B) are recalled because in-line nebulizer configuration in certain locations could cause aerosol accumulation on the internal flow sensor, potentially resulting in inaccurate measurements.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This is a Class I recall per FDA classification, which sets a minimum severity of Severe. Although no illnesses or deaths have been reported and the hazard is described as potential rather than realized, the critical nature of the affected device and the Class I designation warrant a Severe rating.

Plain-English summary

Philips Respironics is recalling the Trilogy Evo Universal Ventilator (Model DS2000X11B) due to a potential safety issue involving in-line nebulizer configuration.

The recall affects 9,999 units distributed worldwide, including throughout the United States. The ventilator is designed for invasive and non-invasive ventilation of pediatric through adult patients weighing at least 2.5 kg in institutional, home, and non-emergency transport settings.

The concern is that when an in-line nebulizer is used in certain locations, aerosol deposits may accumulate on the device's internal flow sensor. This accumulation could result in inaccurate flow measurements, potentially affecting the ventilator's ability to deliver accurate respiratory support.

Patients, caregivers, and healthcare facilities should contact Philips Respironics for guidance on this recall.

The recalled product

Product
Trilogy Evo Universal Ventilator. Model Number DS2000X11B. Intended for invasive and non-invasive ventilation of pediatric through adult patients weighing at least 2.5 kg in institutional, home, and non-emergency transport settings.
Manufacturer
Philips Respironics, Inc.
Category
Medical Device — Ventilator
Hazard
  • aerosol-accumulation
  • flow-measurement-error

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Model Number DS2000X11B
  • UDI-DI Number: 606959052000. All Serial Numbers.

Distribution

Distributed nationwide across the United States.

Related recalls

Same category