The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-0290-2025·Announced 2024-11-20

Trilogy Evo O2 Ventilators Recalled for Potential Flow Sensor Malfunction

Philips Respironics recalled 24,249 Trilogy Evo O2 ventilators because in-line nebulizer configurations may allow aerosol deposits to accumulate on the device's flow sensor, potentially causing inaccurate flow measurements.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This is an FDA Class I medical device recall. Per the severity rubric, FDA Class I recalls must never score below 4. No reported illnesses or deaths are mentioned in the source, which precludes a Critical (5) rating, but the classification and the potential for measurement errors in a critical respiratory device justify the Severe classification.

Plain-English summary

Philips Respironics is recalling 24,249 units of the Trilogy Evo O2 ventilator. This device is intended for invasive and non-invasive ventilation of pediatric and adult patients weighing at least 2.5 kg in institutional, home, and non-emergency transport settings. The recalled units have been distributed worldwide, including the United States.

The recall addresses a potential hazard in which an in-line nebulizer configuration in certain locations may result in aerosol deposit accumulation on the device's internal flow sensor. This accumulation could lead to inaccurate flow measurements.

Affected patients and healthcare providers should contact Philips Respironics for information about this recall.

The recalled product

Product
Trilogy Evo O2. Model Numbers: FP2100X10, DS2100X11B, IN2100X15B, DE2100X13B, IA2100X15B, EU2100X15B, LA2100X15B, EE2100X15B, FX2100X15B, ES2100X15B, ND2100X15B, FR2100X14B, IT2100X21B, JP2100X16B, IN2100X19, EU2100X19. Intended for invasive and non-invasive ventilation of…
Manufacturer
Philips Respironics, Inc.
Category
Medical Device — Respiratory / Ventilator
Hazard
Affected units
24,249

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 (16)

  • Model Number (UDI-DI Number): DE2100X13B (606959054103)
  • DS2100X11B (606959051997)
  • EE2100X15B (606959055698)
  • ES2100X15B (606959054097)
  • EU2100X15B (606959055674)
  • EU2100X19 (606959055681)
  • FP2100X10 (606959062085)
  • FR2100X14B (606959055643)
  • FX2100X15B (606959061019)
  • IA2100X15B (606959055636)
  • IN2100X15B (606959054059)
  • IN2100X19 (606959055575)
  • IT2100X21B (606959055438)
  • JP2100X16B (606959055582)
  • LA2100X15B (606959055599)
  • ND2100X15B (606959055650). All Serial Numbers.

Distribution

Distributed nationwide across the United States.

The notice also names 12 states specifically:

Part of a larger recall action

This product is one of 7 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 7 products in this recall →

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