# FDA recall Z-0494-2022

> **Philips Respironics, Inc.** · Class I · device recall initiated 2021-12-22.

## Product

Trilogy Evo Repair Kit, RP-Trilogy Evo Muffler Assembly, Material Number 1135257    The Trilogy Evo ventilator provides continuous or intermittent positive pressure ventilation for the care of individuals who require mechanical ventilation. Trilogy Evo is intended for pediatric through adult patients weighing at least 2.5 kg.

## Reason for recall

Philips has identified a specific lot of non-conforming material manufactured by one of its suppliers.  A Philips supplier incorrectly used polyester-based polyurethane (PE-PUR) sound abatement foam, a non-conforming material in the devices and repair kits. PE-PUR foam may degrade into particles which may enter the device s air pathway and be ingested or inhaled by the user. The foam degradation may be exacerbated by use of unapproved cleaning methods such as unapproved ozone cleaners, and the PE-PUR foam may off-gas certain chemicals during initial use of the device.

## Distribution

Worldwide Distribution: Distributed to the following US states:  AR, CO, FL, IA, IL, KY, LA, MI, MT, OH, PA, TN, TX, UT, VA, WV, and WY; and Distributed to the following foreign countries: Argentina, Brazil, Romania, and Netherlands.

## Key facts

- **Recall number:** Z-0494-2022
- **Recalling firm:** Philips Respironics, Inc.
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-12-22
- **Report date:** 2022-02-02

- **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-0494-2022

## Citation

> AI Analytics. FDA recall Z-0494-2022. Retrieved 2026-07-12 from https://api.ai-analytics.org/recall/Z-0494-2022. Source: US FDA. Licensed CC0.

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