# FDA recall Z-1812-2024

> **Philips Respironics, Inc.** · Class I · device recall initiated 2024-03-26.

## Product

BiPAP V30 Auto Ventilator, Part Number 1111178

## Reason for recall

Potential for devices to experience interruption/loss of therapy during a Ventilator Inoperative alarm. This may lead to hypoventilation, mild to severe hypoxemia, hypercarbia, respiratory failure/insufficiency, or potentially death in the most vulnerable patients.

## Distribution

Worldwide distribution. US Nationwide including PR and GU; Austria, Belgium, Cyprus, Czech Republic, Denmark, France, Germany, Hungary, Italy, Netherlands, Poland, Portugal, Romania, Serbia, Slovakia, Spain, and Turkey.

## Key facts

- **Recall number:** Z-1812-2024
- **Recalling firm:** Philips Respironics, Inc.
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-03-26
- **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-1812-2024

## Citation

> AI Analytics. FDA recall Z-1812-2024. Retrieved 2026-07-15 from https://api.ai-analytics.org/recall/Z-1812-2024. Source: US FDA. Licensed CC0.

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