# FDA recall Z-0785-2022

> **Philips Respironics, Inc.** · Class I · device recall initiated 2018-06-12.

## Product

Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent Continuous Ventilators    The device is intended to be used in home, institution/hospital, and portable applications such as wheelchairs and gurneys, and may be used for both invasive and non-invasive ventilation. It is not intended to be used as a transport ventilator.

## Reason for recall

In 2018, Philips Respironics added foam replacement to the preventive maintenance schedule for these devices after discovering the polyester-based polyurethane (PE-PUR) foam may degrade into particles.  This 2018 correction has been superseded by the device removal and rework described in Philips Respironics 2021 recall action for the same devices.

## Distribution

Global Distribution.  US Nationwide.

## Key facts

- **Recall number:** Z-0785-2022
- **Recalling firm:** Philips Respironics, Inc.
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2018-06-12
- **Report date:** 2022-03-30

- **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-0785-2022

## Citation

> AI Analytics. FDA recall Z-0785-2022. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0785-2022. Source: US FDA. Licensed CC0.

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