FDA Device recall Z-1181-2016
Puritan Bennett 980 Ventilator System, PB980 Ventilator (980xxxxxxxx)
- FDA Device
- Class II
- terminated
- Published 2016-03-23
On 2016-03-23 the FDA classified a Class II recall of Puritan Bennett 980 Ventilator System, PB980 Ventilator (980xxxxxxxx) by Covidien Formerly Nellcor Puritan Bennett, citing graphical user interface (GUI) unresponsive to touch and Loss of primary ventilation under certain circumstances. Covidien Respiratory and Monitoring Solutions, now a part of Medt….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1181-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-01-15 |
| Published | 2016-03-23 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Covidien Formerly Nellcor Puritan Bennett |
| Distribution | PR |
Product
Puritan Bennett 980 Ventilator System, PB980 Ventilator (980xxxxxxxx). Intended to provide continuous ventilation for pediatric and adult patients who require either invasive ventilation or non-invasive ventilation.
Reason
Graphical user interface (GUI) unresponsive to touch and Loss of primary ventilation under certain circumstances. Covidien Respiratory and Monitoring Solutions, now a part of Medtronic, issued a field corrective action notice for two issues on all models of Puritan Bennett 980 (PB980) ventilator.
Identifiers
| code_info | all versions of software. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1181-2016%22
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