FDA recall Z-0966-2022

Product

Puritan Bennett 980 Series Ventilator

Reason for recall

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.

Distribution

US Nationwide - Worldwide .Distribution

Key facts

Status

Ongoing

Initiation date

2022-03-25

Report date

2022-05-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

Galway, Ireland

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0966-2022