FDAJanuary 15, 2016device

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.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

covidien lp formerly nellcor puritan bennett inccovidiencovidien lp

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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