FDA-Device2021-07-21Class I
A-Series BiPAP A 40, A-Series BiPAP A30 Continuous Ventilator, Non-life Supporting
Philips Respironics, Inc.
Hazard
The polyester-based polyurethane (PE-PUR) foam may degrade into particles which may enter the devices air pathway and be ingested or inhaled by the user, and the PE-PUR foam may off-gas certain chemicals.
Sold states
Worldwide distribution including US Nationwide, Argentina, Australia, Brazil, Canada, China, France, Germany, Italy, Japan, Korea, and Latin America.
Affected count
72665
Manufactured in
1001 Murry Ridge Ln, Murrysville, PA, United States
Products
A-Series BiPAP A 40, A-Series BiPAP A30 Continuous Ventilator, Non-life Supporting
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1958-2021Don't want to check this manually?
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