FDA-Device2022-09-14Class I
Philips BiPAP A40, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency.
Philips Respironics, Inc.
Hazard
Motor assemblies manufactured with nonconforming plastic that contributes to off-gassing of VOCs.
Sold states
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.
Affected count
1,091 units ***updated Jan 2024*** additional 323 units
Manufactured in
1001 Murry Ridge Ln, N/A, Murrysville, PA, United States
Products
Philips BiPAP A40, Rx Only. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and respiratory insufficiency.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1655-2022Don't want to check this manually?
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