The Recall Desk
SevereFDA (Devices)·Z-0944-2020·Announced 2020-02-26

Philips Respironics Recalls Trilogy EVO Ventilators Due to Software Alarm Defect

Philips Respironics is recalling 31 Trilogy EVO Ventilators due to a software defect that 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 recall is classified as FDA Class I, which mandates a severity score of at least 4 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 31 units of the Trilogy EVO Ventilator (Model Number: DE2110X13B) due to a software defect. The affected units are running software versions SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, or 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 defect causes an incorrect or unexpected result that fails requirements TSRS1298 and PRD439. The recall is classified as Class I by the U.S. Food and Drug Administration. The affected devices were distributed to the following countries: CH, DE, DK, IT, FR, IE, GB, KW, QA, PL, ES, AT, PH, AE, SI, and CZ. No units were distributed in the United States.

Healthcare providers and facilities should identify any affected units by checking the model number and serial numbers listed in the recall notice. Users should contact Philips Respironics for instructions on how to address the software defect.

The recalled product

Product
Trilogy EVO Ventilator, Germany - Model Number: DE2110X13B 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
31

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: DE2110X13B Serial Numbers: H23708996882F
  • H24371560D579
  • H255384963A07
  • H2579305546B6
  • H2579306309E8
  • H23616736C469
  • H236241588BA4
  • H23626795164E
  • H23626844FD78
  • H236271027F8B
  • H236283633D93
  • H257930373174
  • H25793039D80A
  • H257930621861
  • H257930656CDE
  • H25793068B73B
  • H24740249E6D6
  • H24740326102D
  • H2474037887EB
  • H24740441BC47

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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