# FDA recall Z-1656-2022

> **Philips Respironics, Inc.** · Class I · device recall initiated 2022-08-26.

## Product

Philips BiPAP V30 Auto, Rx Only.  To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency.

## Reason for recall

Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs.

## Distribution

Domestic: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NV, NY, OH, OK, OR, PA, TN, TX, VA, VT, WA, WI, WV, & WY.  Foreign: Australia, Austria, Bangladesh, Brazil, Canada, China, Denmark, Egypt, France, Germany, Hong Kong, Hungary, India, Israel, Italy, Japan, Malaysia, Mexico, Myanmar, Philippines, Qatar, Serbia, Singapore, Taiwan, Thailand, Turkey, UAE, & UK.

## Key facts

- **Recall number:** Z-1656-2022
- **Recalling firm:** Philips Respironics, Inc.
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-08-26
- **Report date:** 2022-09-14

- **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-1656-2022

## Citation

> AI Analytics. FDA recall Z-1656-2022. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1656-2022. Source: US FDA. Licensed CC0.

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