FDA Device recall Z-0966-2022
Puritan Bennett 980 Series Ventilator
- FDA Device
- Class I
- ongoing
- Published 2022-05-04
On 2022-05-04 the FDA classified a Class I recall of Puritan Bennett 980 Series Ventilator by Medtronic Formerly Covidien, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0966-2022 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2022-03-25 |
| Published | 2022-05-04 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Medtronic Formerly Covidien |
| Distribution | US |
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.
Identifiers
| code_info | Lot/Serial Number | Product GTIN/MATNR 35B2014306 10884521171633 35B2014309 10884521171633 35B2014312 10884521171633 35…Lot/Serial Number | Product GTIN/MATNR 35B2014306 10884521171633 35B2014309 10884521171633 35B2014312 10884521171633 35B2014314 10884521171633 35B1500319 10884521201408 35B1500321 10884521201521 35B1500322 10884521201408 35B1500323 10884521201408 35B1500324 10884521201408 35B1500718 10884521201408 35B1500744 10884521201408 35B1500758 10884521201408 35B1500773 10884521201408 35B1502000 10884521212251 35B1502094 10884521201354 35B1502099 10884521201354 35B1502104 10884521201354 35B1502172 10884521201224 35B1600140 10884521201224 35B1600170 10884521201224 35B1600182 10884521201224 35B1600188 10884521201224 35B1600198 10884521201224 35B1600202 10884521201224 35B1600203 10884521201224 35B1600204 10884521201224 35B1600209 10884521201224 35B1600211 10884521201224 35B1600213 10884521212251 35B1600216 10884521201224 35B1600217 10884521201897 35B1600218 10884521201910 35B1600221 10884521201224 35B1600225 10884521201224 35B1600228 10884521201224 35B1600242 10884521201224 35B1600251 10884521201224 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0966-2022%22
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