FDA-Device2022-09-14Class I
Philips OmniLab Advanced+ Intl (Flow Gen), 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
34 units ***updated January 2024 *** additional 3 units
Manufactured in
1001 Murry Ridge Ln, N/A, Murrysville, PA, United States
Products
Philips OmniLab Advanced+ Intl (Flow Gen), 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-1658-2022Don't want to check this manually?
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