# FDA recall Z-1652-2023

> **Philips Respironics, Inc.** · Class I · device recall initiated 2023-05-01.

## Product

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.

## Distribution

US Nationwide.  Global Distribution.

## Key facts

- **Recall number:** Z-1652-2023
- **Recalling firm:** Philips Respironics, Inc.
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-05-01
- **Report date:** 2023-06-14

- **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-1652-2023

## Citation

> AI Analytics. FDA recall Z-1652-2023. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-1652-2023. Source: US FDA. Licensed CC0.

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