Philips Respironics, Inc.: Medical Device Recall in 2020 - (Recall #: Z-0949-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

Trilogy EVO Ventilator, France - Model Number: FR2110X14B 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.

Product Classification:

Class I

Date Initiated: November 19, 2019

Date Posted: February 26, 2020

Recall Number: Z-0949-2020

Event ID: 84406

Reason for Recall:

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.

Status: Terminated

Product Quantity: 5

Code Information:

Model/Material Number: FR2110X14B Serial Numbers: H248213027F13, H249718745CF4, H252330869C7A, H252331053AFD, H255249974881,

Distribution Pattern:

US: None OUS: CH DE DK IT FR IE GB KW QA PL ES AT PH AE SI CZ

Voluntary or Mandated:

Voluntary: Firm initiated