The Recall Desk
HighFDA (Devices)·Z-2287-2021·Announced 2021-08-25

Trilogy Evo Ventilator Software Defect May Cause Pressure Increase

Philips Respironics recalls Trilogy Evo ventilators due to software issues that may increase pressure delivery to patients. The defect affects multiple product variants worldwide.

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 no reported illnesses or injuries. Device malfunction poses potential risk of harm to respiratory patients, but hazard remains theoretical without documented injury, qualifying for High severity.

Plain-English summary

Philips Respironics, Inc. has recalled the Trilogy Evo ventilator due to software defects that may increase the pressure delivered to patients. The defect affects multiple product variants with specific product numbers and software versions 1.02.01.00 through 1.06.02.

Two specific software issues have been identified: an "Infant/Pediatric EFS Calibration Pressure Increase" and a "Pressure Drift (Continuous Usage)" issue. Both defects are related to abnormal pressure delivery in the device.

The recall affects 18,588 units distributed in the United States and 5,662 units distributed internationally. This is a Class II recall issued by the U.S. Food and Drug Administration.

The recalled product

Product
Trilogy Evo, Product numbers BL2110X15B, CA2110X12B, DE2110X13B, DS2110X11B, EE2110X15B, ES2110X15B, EU2110X15B, EU2110X19, FR2110X14B, GB2110X15B, IA2110X15B, IN2110X15B, IN2110X19, IT2110X21B, KR2110X15B, LA2110X15B, LD2110X23B, ND2110X15B, RDE2110X13B, UDS2110X11B
Manufacturer
Philips Respironics, Inc.
Category
Medical Device — Ventilator
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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