The Recall Desk
HighFDA (Devices)·Z-2288-2021·Announced 2021-08-25

Trilogy Evo O2 Ventilator Software Issues Affecting Pressure Delivery

Philips Respironics is recalling Trilogy Evo O2 ventilators with software issues that can increase pressure delivery. One issue affects infant/pediatric settings; another causes pressure drift during continuous use.

What this means for you

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 recall with identified software issues causing abnormal pressure delivery in a critical respiratory device. While no illnesses or injuries are reported in the source material, the potential for serious complications from abnormal pressure in a ventilator used by diverse patient populations, including infants and pediatric patients, represents a significant risk of harm.

Plain-English summary

Philips Respironics, Inc. is recalling the Trilogy Evo O2 ventilator due to two identified software issues. Both issues affect the delivery of pressure to patients using the device.

The first issue is described as Infant/Pediatric EFS (Extra-Flexible System) Calibration Pressure Increase, which specifically affects the calibration settings for pediatric and infant patients. The second issue is described as Pressure Drift during Continuous Usage, which can occur at any time the device is in use. Both conditions can result in abnormal pressure delivery.

The recalled devices include product numbers DE2100X13B, DS2100X11B, EE2100X15B, ES2100X15B, EU2100X15B, FR2100X14B, FX2100X15B, IA2100X15B, IN2100X15B, IN2100X19, IT2100X21B, JP2100X16B, LA2100X15B, ND2100X15B, RDE2100X13B, and SP2100X26B with software versions 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. These ventilators have been distributed worldwide, including 101 units in the FEMA Stockpile and 21,077 units outside the United States.

The recalled product

Product
Trilogy Evo O2, Product numbers DE2100X13B, DS2100X11B, EE2100X15B, ES2100X15B, EU2100X15B, FR2100X14B, FX2100X15B, IA2100X15B, IN2100X15B, IN2100X19, IT2100X21B, JP2100X16B, LA2100X15B, ND2100X15B, RDE2100X13B, SP2100X26B
Manufacturer
Philips Respironics, Inc.
Category
Medical Device — Respiratory
Hazard
  • pressure-increase
  • pressure-drift

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.

Related recalls

Same category