Medical Device Recall: BiPAP V30 Auto Ventilator, Part Number 1111178
Philips Respironics, Inc. · March 26, 2024
Reason for Recall
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.
Distribution
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.
States Affected
NATIONWIDE
Quantity Affected
5,958 US; None OUS
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1812-2024
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.