Reported Mar 23, 2016 · Terminated
Puritan Bennett 980 Ventilator System, PB980 Ventilator (980xxxxxxxx). Intended to provide continuous ventilation for…
Covidien LP (formerly Nellcor Puritan Bennett Inc.)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Covidien LP (formerly Nellcor Puritan Bennett Inc.) · 6135 Gunbarrel Ave · Boulder, CO · 80301-3214
Is this the product you have?
- 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.
- Lot codes and dates
- all versions of software.
- Amount recalled
- 1,864 units
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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