FDA recall Z-1817-2024

Product

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

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.

Key facts

Status

Ongoing

Initiation date

2024-04-01

Report date

2024-05-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

Murrysville, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1817-2024