Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0954-2020 — LifeVent EVO Ventilator, 02 - Model Number: SP2100X26B 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 accessories.

U.S. FDA — Device Enforcement · United States · 2019-11-19 · Class I

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0954-2020
Date of alert: 2019-11-19
Country / jurisdiction: United States
Risk level: Class I
Risk type: recall
Brand: Philips Respironics, Inc.
Product category: device
Product type: Devices

Reported risk: 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 result failing requirements TSRS1298 and PRD439.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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