Philips Respironics, Inc. recalls Philips BiPAP V30 Auto, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea s

Recalled September 14, 2022 · FDA recall Z-1656-2022 · Philips Respironics

Hazard

Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs. · FDA Class I

Units

295 units

Sold at

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.

Description

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

Product

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

Manufacturer(s)

Philips Respironics, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →