The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2289-2021·Announced 2021-08-25

Trilogy EV300 Ventilator Recalled for Software-Related Pressure Calibration Issues

Philips Respironics is recalling the Trilogy EV300 ventilator due to software issues causing pressure calibration errors affecting infant and pediatric patients. The defects impact 18,936 units distributed in the United States.

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: FDA Class II respiratory device with identified software issues causing pressure calibration errors affecting vulnerable populations, particularly infants and pediatric patients. No illnesses or injuries reported in the source material, limiting severity to the High category per the rubric criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Philips Respironics, Inc. is recalling the Trilogy EV300 ventilator due to software issues affecting pressure calibration and stability. This recall impacts 18,936 units in the United States and 4,659 units distributed outside the United States.

Two software defects have been identified in the affected device. The first causes pressure increases in infant and pediatric calibration modes. The second causes pressure to drift during continuous device operation. The affected software versions include 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 Trilogy EV300 is a portable ventilator designed to provide respiratory support to patients who have difficulty breathing. Patients—particularly infants and children—depend on accurate pressure calibration to receive safe, effective ventilation therapy.

Patients using the Trilogy EV300 should verify their device's software version, which can typically be found in the device settings or documentation. Contact Philips Respironics directly for information about software updates or other remediation options.

The recalled product

Product
Trilogy EV300, Product numbers CA2200X12B, DS2200X11B, FX2200X15B, IN2200X15B
Manufacturer
Philips Respironics, Inc.
Category
Medical Device — Respiratory Ventilation
Hazard

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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