# FDA recall Z-1957-2021

> **Philips Respironics, Inc.** · Class I · device recall initiated 2021-06-14.

## Product

A-Series BiPAP Hybrid A30 (not marketed in US), A-Series BiPAP V30 Auto Continuous Ventilator, Minimum Ventilatory Support, Facility Use

## Reason for recall

The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the devices air pathway and be ingested or inhaled by the user, and the PE-PUR foam may off-gas certain chemicals.

## Distribution

Worldwide distribution including US Nationwide, Argentina, Australia, Brazil, Canada, China, France, Germany, Italy, Japan, Korea, and Latin America.

## Key facts

- **Recall number:** Z-1957-2021
- **Recalling firm:** Philips Respironics, Inc.
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-06-14
- **Report date:** 2021-07-21

- **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-1957-2021

## Citation

> AI Analytics. FDA recall Z-1957-2021. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-1957-2021. Source: US FDA. Licensed CC0.

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