FDA-Device2024-05-29Class I
BiPAP V30 Auto Ventilator, Part Number 1111178
Philips Respironics, Inc.
Hazard
Potential for devices to experience interruption/loss of therapy during a Ventilator Inoperative alarm. This may lead to hypoventilation, mild to severe hypoxemia, hypercarbia, respiratory failure/insufficiency, or potentially death in the most vulnerable patients.
Sold states
Worldwide distribution. US Nationwide including PR and GU; Austria, Belgium, Cyprus, Czech Republic, Denmark, France, Germany, Hungary, Italy, Netherlands, Poland, Portugal, Romania, Serbia, Slovakia, Spain, and Turkey.
Affected count
5,958 US; None OUS
Manufactured in
1001 Murry Ridge Ln, Murrysville, PA, United States
Products
BiPAP V30 Auto Ventilator, Part Number 1111178
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1812-2024Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief