# FDA recall Z-1629-2021

> **Philips Respironics, Inc.** · Class II · device recall initiated 2021-04-06.

## Product

BiPAP A30, Brazil: Continuous ventilator, non-life-supporting.  Material Number: BR1111143

## Reason for recall

Certain devices were built with motor assemblies that could contain non-conforming plastic material. This could result in 1. Exposure to off-gassing of Volatile Organic Compounds not normally present creating a potential biosafety or toxicological hazard and 2. Sudden failure of the device causing a Ventilator Inoperative condition with the potential for asphyxia if not immediately identified and addressed by the care provider.

## Distribution

Distribution US nationwide to states of:  LA, PA, WI, CO, WV, WA, CA, TX, MO, OK, FL, and TN.  Brazil, China, and Japan

## Key facts

- **Recall number:** Z-1629-2021
- **Recalling firm:** Philips Respironics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-04-06
- **Report date:** 2021-06-02
- **Termination date:** 2024-01-17

- **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-1629-2021

## Citation

> AI Analytics. FDA recall Z-1629-2021. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1629-2021. Source: US FDA. Licensed CC0.

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