# FDA recall Z-1650-2023

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

## Product

Trilogy Evo O2 and LifeVent EVO2, Model Numbers DS2100X11B, IN2100X15B, IN2100X19, FX2100X15B, LA2100X15B, IA2100X15B, FP2100X10, FR2100X14B, ND2100X15B, IT2100X21B, ES2100X15B, DE2100X13B, EU2100X15B, EU2100X19, EE2100X15B, and SP2100X26B

## Reason for recall

Environmental debris may accumulate on the internal machine flow sensor causing partial occlusion which may impact accurate delivery of pressure, volume, or flow. A malfunction caused by this issue can result in patient harm up to hypoxemia if not addressed by the care provider.

## Distribution

US Nationwide.  Global Distribution.

## Key facts

- **Recall number:** Z-1650-2023
- **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-1650-2023

## Citation

> AI Analytics. FDA recall Z-1650-2023. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1650-2023. Source: US FDA. Licensed CC0.

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