FDA Device recall Z-0942-2020
Trilogy EVO Ventilator, International, Model Number IN2110X15B Trilogy Evo is intended for pediatric through adult patients weighing at lea…
- FDA Device
- Class I
- terminated
- Published 2020-02-26
On 2020-02-26 the FDA classified a Class I recall of Trilogy EVO Ventilator, International, Model Number IN2110X15B Trilogy Evo is intended for pediatric through adult patients weighing at lea… by Philips Respironics, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0942-2020 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2019-11-19 |
| Published | 2020-02-26 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Philips Respironics |
| Distribution | DE |
Product
Trilogy EVO Ventilator, International, Model Number IN2110X15B 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.
Reason
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.
Identifiers
| code_info | Model/Material Number: IN2110X15B Serial Numbers: H23502245F792, H257875388996, H2578757062BE, H25787599656F, H2578762…Model/Material Number: IN2110X15B Serial Numbers: H23502245F792, H257875388996, H2578757062BE, H25787599656F, H25787620F362, H25787645F01F, H25787664D226, H257876844836, H257877329374, H257877487126, H25787767BA61, H2578778054CE, H25793096DD8D, H2579309834F3, H25793099257A, H25793100357F, H25793102166D, H2579310307E4, H257970640FBB, H25797184CF77, H257992176BD2, |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0942-2020%22
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