Philips Respironics Recalls Trilogy EVO Ventilators Due to Software Defect
Philips Respironics is recalling specific Trilogy EVO ventilators because a software defect causes power alarms to fail, potentially leaving patients without critical alerts.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The source text explicitly states the agency classification is Class I, which mandates a severity score of 5 (Critical) according to the rubric.
Plain-English summary
Philips Respironics, Inc. is recalling specific units of the Trilogy EVO Ventilator (Model Number: ES2100X15B) and Trilogy EVO Universal Ventilator. The recall affects units running software versions SW 1.00.05, SW 1.01.09.00, SW 1.01.10.00, or SW 1.01.11.00. The device is intended for pediatric through adult patients weighing at least 2.5 kg.
The recall is due to a software defect that causes inoperative and loss of all power alarms. This defect results in incorrect or unexpected outcomes that fail specific safety requirements (TSRS1298 and PRD439). The loss of power alarms means the device may not alert users to critical power issues.
The recall is classified as Class I by the FDA, indicating a reasonable probability that use of the product will cause serious adverse health consequences or death. The distribution pattern indicates the affected units were distributed outside the United States to countries including CH, DE, DK, IT, FR, IE, GB, KW, QA, PL, ES, AT, PH, AE, SI, and CZ. No specific serial numbers are listed in the provided source text other than a single example (H24371562F66B). Users should contact the manufacturer for instructions on how to address the software defect.
The recalled product
- Product
- Trilogy EVO Ventilator, 02 - Iberia - Model Number: ES2100X15B 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…
- Manufacturer
- Philips Respironics, Inc.
- Category
- Medical Device — Ventilator
- Affected units
- 1
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 (1)
- Model/Material Number: ES2100X15B Serial Numbers: H24371562F66B
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 →Related recalls
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