FDA-Device2022-05-04Class I
Puritan Bennett 980 Series Ventilator
Medtronic formerly Covidien
Hazard
The audible alarm may not sound and/or the omni-directional LED visual alarm may not display during alarm states. Delayed awareness of alarm states may lead to delayed response or a delay of treatment, potentially resulting in hypoxia, dyspnea, cardiac arrest, or death.
Sold states
US Nationwide - Worldwide .Distribution
Affected count
18,508 OUS; 18,412 US
Manufactured in
Michael Collins Road, Mervue Ind. Park, Galway, Ireland
Products
Puritan Bennett 980 Series Ventilator
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0966-2022Don't want to check this manually?
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