FDA-Device2021-07-21Class I
A-Series BiPAP Hybrid A30 (not marketed in US), A-Series BiPAP V30 Auto Continuous Ventilator, Minimum Ventilatory Support, Facility Use
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
8047
Manufactured in
1001 Murry Ridge Ln, Murrysville, PA, United States
Products
A-Series BiPAP Hybrid A30 (not marketed in US), A-Series BiPAP V30 Auto Continuous Ventilator, Minimum Ventilatory Support, Facility Use
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1957-2021Don't want to check this manually?
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