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Medtronic formerly Covidien recalls Puritan Bennett 980 Series Ventilator
Recalled May 4, 2022 · FDA recall Z-0966-2022 · 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. · FDA Class I
Units
18,508 OUS; 18,412 US
Sold at
US Nationwide - Worldwide .Distribution
Description
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.
Product
Puritan Bennett 980 Series Ventilator
Manufacturer(s)
Medtronic formerly Covidien
Made in
Ireland
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →