# FDA recall Z-0944-2020

> **Philips Respironics, Inc.** · Class I · device recall initiated 2019-11-19.

## Product

Trilogy EVO Ventilator, Germany - Model Number: DE2110X13B    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 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.

## Distribution

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

## Key facts

- **Recall number:** Z-0944-2020
- **Recalling firm:** Philips Respironics, Inc.
- **Classification:** Class I
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-11-19
- **Report date:** 2020-02-26
- **Termination date:** 2021-03-31

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Murrysville, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0944-2020

## Citation

> AI Analytics. FDA recall Z-0944-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0944-2020. Source: US FDA. Licensed CC0.

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