# FDA recall Z-0883-2023

> **Philips Respironics, Inc.** · Class I · device recall initiated 2022-12-07.

## Product

Philips Trilogy 200 Ventilator, Model Numbers 1040005, U1040005, 1040005B, U1040005B, CA1032800B, CA1032800, KO1032800, 1032800, R1032804TP, R1032804B, R1032804TPV, 1032804B

## Reason for recall

The replacement silicone sound abatement foam installed into some Trilogy 100 and Trilogy 200 devices may separate from the plastic backing to which it is attached. If this were to happen, the foam could potentially block air inlet, which could result in a reduction in delivered therapy volume or pressure and could cause the device to alarm.

## Distribution

US Nationwide and Global Distribution to countries of: Australia, Brazil, Canada, China, Germany, Japan, Korea, and Latin America.

## Key facts

- **Recall number:** Z-0883-2023
- **Recalling firm:** Philips Respironics, Inc.
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-12-07
- **Report date:** 2023-01-18

- **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-0883-2023

## Citation

> AI Analytics. FDA recall Z-0883-2023. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0883-2023. Source: US FDA. Licensed CC0.

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