Puritan Bennett 980 Series Ventilator
Reported: May 4, 2022 Initiated: March 25, 2022 #Z-0966-2022
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.
Details
- Recalling Firm
- Medtronic formerly Covidien
- Units Affected
- 18,508 OUS; 18,412 US
- Distribution
- US Nationwide - Worldwide .Distribution
- Location
- Galway
Frequently Asked Questions
What product was recalled? ▼
Puritan Bennett 980 Series Ventilator. Recalled by Medtronic formerly Covidien. Units affected: 18,508 OUS; 18,412 US.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 4, 2022. Severity: Critical. Recall number: Z-0966-2022.
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