# FDA recall Z-1817-2024

> **Philips Respironics, Inc.** · Class I · device recall initiated 2024-04-01.

## Product

OmniLab Advanced + Ventilator    Product Numbers   1111122	1111123	1111124	1111125	1111126	1111127	1111138	1111141	1111142	KR1111127	R1111122	R1111123	R1111124	U1111122	U1111124

## Reason for recall

Device may experience an interruption or loss of therapy in case of a Ventilator Inoperative alarm. This may lead to hypoventilation, mild to severe hypoxemia, hypercarbia, respiratory failure/insufficiency, or potentially death.

## Distribution

US Nationwide distribution and OUS International distribution to Canada.

## Key facts

- **Recall number:** Z-1817-2024
- **Recalling firm:** Philips Respironics, Inc.
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-04-01
- **Report date:** 2024-05-29

- **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-1817-2024

## Citation

> AI Analytics. FDA recall Z-1817-2024. Retrieved 2026-07-17 from https://api.ai-analytics.org/recall/Z-1817-2024. Source: US FDA. Licensed CC0.

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