The Recall Desk
SevereFDA (Devices)·Z-0953-2020·Announced 2020-02-26

Philips Respironics Recalls Trilogy EVO Ventilators Due to Software Defect

Philips Respironics is recalling 27 Trilogy EVO ventilators because a software defect causes the loss of all power alarms.

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: The agency classification is FDA Class I, which mandates a minimum severity score of 4 according to the rubric.

Plain-English summary

Philips Respironics, Inc. is recalling 27 units of the Trilogy EVO Ventilator, Model Number EU2100X15B. The recall involves specific software versions (SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, and SW 1.01.11.00) that contain a defect causing inoperative and loss of all power alarms. This defect results in incorrect or unexpected outcomes that fail specific safety requirements.

The affected devices are intended for pediatric through adult patients weighing at least 2.5 kg. The ventilators are capable of measuring, displaying, recording, and alarming SpO2, FiO2, CO2, and Pulse Rate data when integrated with appropriate accessories. The recall is classified as Class I by the FDA.

The distribution pattern indicates that the affected units were not distributed in the United States. They were distributed in the following countries: CH, DE, DK, IT, FR, IE, GB, KW, QA, PL, ES, AT, PH, AE, SI, and CZ. Specific serial numbers for the 27 affected units are listed in the official recall documentation.

The recalled product

Product
Trilogy EVO Ventilator, 02 - EU - Model Number: EU2100X15B Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg. The ventilator can measure, display, record, and alarm SpO2, FiO2, CO2, and Pulse Rate data when integrated with the appropriate ac
Manufacturer
Philips Respironics, Inc.
Category
Medical Device — Ventilator
Hazard
Affected units
27

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/Material Number: EU2100X15B Serial Numbers: H23987675BB18
  • H243715497B08
  • H243715587359
  • H2476245817A0
  • H255250576184
  • H2552506568FE
  • H25538501C37C
  • H25538516AE1B
  • H25538554EA69
  • H255386102449
  • H25538612075B
  • H255386332562
  • H2553865152A0
  • H256064131C99
  • H256064175ABD
  • H2560642115E3
  • H2560642336F1
  • H25781710C84C
  • H2578205663D2
  • H257821415469

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 13 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 13 products in this recall →

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