The Recall Desk
SevereFDA (Devices)·Z-1289-2023·Announced 2023-04-12

Philips Trilogy Evo Portable Ventilators Recalled for Inaccurate Oxygen Delivery

Philips Respironics is recalling the Trilogy Evo Universal Portable Electric Ventilator (Model DS2000X11B) because it may deliver oxygen below the prescribed level during high-concentration oxygen therapy, potentially depriving patients of adequate oxygen.

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: FDA Class I medical device recall designation. Although no deaths or reported illnesses are mentioned in the source, the potential for oxygen delivery failure in ventilator-dependent patients creates serious risk of respiratory complications.

Plain-English summary

Philips Respironics is recalling the Trilogy Evo Universal Portable Electric Ventilator, Model Number DS2000X11B. Approximately 62,826 devices are affected, distributed worldwide including throughout the United States and Puerto Rico.

The device may deliver oxygen below the required tolerance level of 5% from the set amount during high-concentration oxygen therapy. Additionally, if equipped with an internal FiO2 sensor, the sensor may display a value higher than what the device is actually delivering, resulting in patients receiving less oxygen than prescribed.

Patients dependent on this ventilator for high-concentration oxygen therapy may experience inadequate oxygen delivery, which could lead to serious respiratory complications.

Affected users should contact their healthcare provider or Philips Respironics immediately for guidance. Do not discontinue device use without consulting your healthcare provider about alternatives.

The recalled product

Product
Trilogy Evo Universal Portable Electric Ventilator, Model Number DS2000X11B
Manufacturer
Philips Respironics, Inc.
Category
Medical Device — Respiratory Equipment
Hazard
Affected units
62,826

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 (20)

  • Model number: DS2000X11B
  • UDI-DI: 606959052000. Serial Numbers: H27736231F4BE
  • H277362379188
  • H27736246CD09
  • H277372867812
  • H27737288916C
  • H2773729661CA
  • H27737302AA2A
  • H27737306EC0E
  • H2773730914F9
  • H27737331B2D9
  • H27737344A87C
  • H277373468B6E
  • H277373596A41
  • H277373815671
  • H2773738401DC
  • H2773740998FC
  • H277374132E7E
  • H277374212704
  • H277374525897

Distribution

Distributed nationwide across the United States.

The notice also names 8 states specifically:

Part of a larger recall action

This product is one of 3 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 3 products in this recall →

Related recalls

Same manufacturer · Philips Respironics, Inc.

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