Recall Z-0966-2022— Medtronic formerly Covidien
Class I · Ongoing
Class I FDA medical device recall by Medtronic formerly Covidien, initiated 2022-03-25. It names one FDA 510(k) clearance: K193056. Product: Puritan Bennett 980 Series Ventilator. Reason: 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..
- Recalling firm
- Medtronic formerly Covidien
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2022-03-25
- Firm location
- Galway, Ireland
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.