The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2290-2021·Announced 2021-08-25

Trilogy Evo Respiratory Device Recalled for Software Pressure Issues

Philips Respironics has recalled Trilogy Evo Universal respiratory devices (model DS2000X11B) for software defects that increase pressure, particularly in pediatric and infant applications.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II medical device recall for a respiratory support device with software defects causing unintended pressure increases in infants and pediatric patients. No hospitalizations or injuries are reported in the source, placing this in the category of risk-of-harm products where injury has not yet been reported.

Plain-English summary

Philips Respironics has recalled the Trilogy Evo Universal respiratory device (model DS2000X11B) due to software defects that affect pressure delivery. Two distinct software issues have been identified: one affecting calibration of pressure delivery to infants and pediatric patients, and another that causes pressure to drift during continuous usage.

Both issues result in unintended pressure increases within the device. For respiratory support equipment used with vulnerable populations, uncontrolled pressure changes pose a risk of harm. The defect affects multiple software versions including 1.02.01.00, 1.03.05.00, 1.03.07.00, 1.04.02.00, 1.04.06, 1.05.01, and 1.06.02.

The device has been distributed worldwide, including throughout the United States, for use in medical facilities and emergency response systems.

The recalled product

Product
Trilogy Evo Universal, Product number DS2000X11B
Manufacturer
Philips Respironics, Inc.
Category
Medical Device — Respiratory Support
Hazard
Affected units
10,000

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 (7)

  • Software version numbers 1.02.01.00
  • 1.03.05.00
  • 1.03.07.00
  • 1.04.02.00
  • 1.04.06
  • 1.05.01
  • and 1.06.02

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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