The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-0948-2020·Announced 2020-02-26

Philips Respironics Recalls Trilogy EVO Ventilators Due to Software Defect

Philips Respironics is recalling 16 Trilogy EVO ventilators because a software defect causes power alarms to become inoperative or lost.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Software defect in the Trilogy EVO and Trilogy EVO Universal Ventilator, versions SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, and SW 1.01.11.00, causing inoperative and loss of all power alarms. This defect causes an incorrect or unexpected…"

Plain-English summary

Philips Respironics, Inc. has initiated a recall of the Trilogy EVO Ventilator (Model Number: ND2110X15B). The company is recalling 16 units due to a software defect identified in versions SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, and SW 1.01.11.00.

The defect causes the ventilator to fail to activate or lose power alarms. This issue results in incorrect or unexpected behavior that fails to meet specific technical requirements (TSRS1298 and PRD439). The affected units were distributed in Switzerland, Germany, Denmark, Italy, France, Ireland, Great Britain, Kuwait, Qatar, Poland, Spain, Austria, the Philippines, the United Arab Emirates, Slovenia, and the Czech Republic.

The recall affects serial numbers H251017836F15, H2523309685A2, H252331351095, H252353329A08, H25504805F0DF, H255049394A07, H2550648781D8, H255065746A57, H25506638283F, H25506755FDD6, H255068597D7D, H25523364DD89, H255249956B93, H25524999A1FF, H2569010452BD, and H2569170852B3.

The recalled product

Product
Trilogy EVO Ventilator, Nordics - Model Number: ND2110X15B 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…
Manufacturer
Philips Respironics, Inc.
Category
Medical Device — Ventilator
Hazard
Affected units
16

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 (16)

  • Model/Material Number: ND2110X15B Serial Numbers: H251017836F15
  • H2523309685A2
  • H252331351095
  • H252353329A08
  • H25504805F0DF
  • H255049394A07
  • H2550648781D8
  • H255065746A57
  • H25506638283F
  • H25506755FDD6
  • H255068597D7D
  • H25523364DD89
  • H255249956B93
  • H25524999A1FF
  • H2569010452BD
  • H2569170852B3

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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