Recall Z-1652-2023— Philips Respironics, Inc.

Name: FDA recall Z-1652-2023
Creator: U.S. Food and Drug Administration
Published: 2023-05-01

Class I · Ongoing

Class I FDA medical device recall by Philips Respironics, Inc., initiated 2023-05-01. It names one FDA 510(k) clearance: K181170. Product: Trilogy Evo Universal Ventilator, Model Number DS2000X11B. Reason: The Trilogy Evo Universal ventilator provides continuous or intermittent positive pressure ventilation for the care of individuals who require mechanical ventilation. Trilogy Evo Universal 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. The ventilator is suitable for use in institutional and hospital settings and non-emergency transport settings; for example, wheelchair. It may be used for both invasive and non-invasive ventilation..

Recalling firm: Philips Respironics, Inc.
Classification: Class I
Status: Ongoing
Initiated: 2023-05-01
Firm location: Murrysville, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K181170 — Trilogy Evo UniversalRespironics, Inc.·cleared 2019-07-18

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Trilogy Evo Universal Ventilator, Model Number DS2000X11B

Reason for recall

The Trilogy Evo Universal ventilator provides continuous or intermittent positive pressure ventilation for the care of individuals who require mechanical ventilation. Trilogy Evo Universal 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. The ventilator is suitable for use in institutional and hospital settings and non-emergency transport settings; for example, wheelchair. It may be used for both invasive and non-invasive ventilation.

Data sourced from openFDA. This site is unofficial and independent of the FDA.