The Recall Desk
CriticalFDA (Devices)·Z-0947-2020·Announced 2020-02-26

Philips Respironics Recalls Trilogy EVO Ventilators Due to Software Alarm Defect

Philips Respironics is recalling 15 Trilogy EVO Ventilators because a software defect causes the loss of all power alarms.

What this means for you

Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.

Our severity reasoning: The recall is classified as FDA Class I, which mandates a severity score of 5 per the rubric, as it involves a reasonable probability of serious adverse health consequences or death due to the loss of critical safety alarms.

Plain-English summary

Philips Respironics, Inc. is recalling 15 units of the Trilogy EVO Ventilator (Model Number: GB2110X15B) due to a software defect. The affected software versions are 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's power alarms to become inoperative, resulting in a loss of all power alarms. This failure causes the device to produce incorrect or unexpected results, failing specific requirements (TSRS1298 and PRD439). The ventilator is intended for pediatric through adult patients weighing at least 2.5 kg.

The recall is classified as Class I by the FDA. The 15 affected units were distributed to countries including Great Britain, Germany, Denmark, Italy, France, Ireland, Kuwait, Qatar, Poland, Spain, Austria, Philippines, United Arab Emirates, Slovenia, and Czechia. No units were distributed in the United States. Specific serial numbers for the affected units are listed in the official recall record.

The recalled product

Product
Trilogy EVO Ventilator, Great Britain - Model Number: GB2110X15B 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 appropri
Manufacturer
Philips Respironics, Inc.
Category
Medical Device — Ventilator
Hazard
Affected units
15

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 (15)

  • Model/Material Number: GB2110X15B Serial Numbers: H24736983B2CC
  • H247625953F39
  • H24999941FF8D
  • H251261507A86
  • H251283213DFD
  • H251283452F09
  • H25128825527F
  • H25128931575F
  • H251291825B15
  • H25129198ED97
  • H255930567C7B
  • H256003738FD6
  • H25621580E26F
  • H256243863FD7
  • H25630201A6DC

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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