The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-0945-2020·Announced 2020-02-26

Philips Respironics Recalls Trilogy EVO Ventilators Due to Software Defect

Philips Respironics is recalling 48 Trilogy EVO ventilators due to a software defect that causes inoperative power alarms. The units were distributed in 15 countries outside the US.

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 as a Class I recall, which per the rubric mandates a score of at least 4 (Severe) due to the potential for serious adverse health consequences from inoperative safety alarms.

Plain-English summary

Philips Respironics, Inc. is recalling 48 units of the Trilogy EVO Ventilator, EU (Model Number: EU2110X15B). The recall is due to a software defect in specific versions (SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, and SW 1.01.11.00) that causes inoperative and loss of all power alarms. This defect results in incorrect or unexpected outcomes that fail specific requirements (TSRS1298 and PRD439).

The affected devices are intended for pediatric through adult patients weighing at least 2.5 kg. The ventilators can measure, display, record, and alarm SpO2, FiO2, CO2, and Pulse Rate data when integrated with appropriate accessories. The recall covers 48 units with specific serial numbers listed in the agency documentation.

Distribution was limited to 15 countries outside the United States, including Germany, France, Italy, and the United Kingdom. No units were distributed in the US. The agency has classified this recall as Class I, indicating a reasonable probability that use of the product will cause serious adverse health consequences or death.

The recalled product

Product
Trilogy EVO Ventilator, EU - Model Number: EU2110X15B 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
48

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: EU2110X15B Serial Numbers: H23570360C0F9
  • H236165266809
  • H236170100251
  • H2362652456D7
  • H2367778607E2
  • H23678062E52A
  • H247381064321
  • H2473940554BC
  • H24752480365C
  • H247526530107
  • H24752695CD91
  • H24758951B47C
  • H249175058F08
  • H24917512E26F
  • H24917524AD31
  • H24917525BCB8
  • H256248595EFE
  • H256275006735
  • H25635324F64A
  • H25689296BBF4

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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