Class I

Medical Device Recall: OmniLab Advanced + Ventilator Product Numbers 1111122 1111123 1111124 1111125 1111126 1111127 1111138 1111141 1111142 KR1111127 R1111122 R1111123 R1111124 U1111122 U1111124

Philips Respironics, Inc. · April 1, 2024

Reason for Recall

Device may experience an interruption or loss of therapy in case of a Ventilator Inoperative alarm. This may lead to hypoventilation, mild to severe hypoxemia, hypercarbia, respiratory failure/insufficiency, or potentially death.

Distribution

US Nationwide distribution and OUS International distribution to Canada.

States Affected

NATIONWIDE

Quantity Affected

9,388 US; 2,664 ROW

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1817-2024

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.