Company: Covidien LP (formerly Nellcor Puritan Bennett Inc.)
Date of Enforcement Report 3/23/2016
Class lI:
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.. Recall Number 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. Recall Number: Z-1181-2016
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.
RECALLING FIRM/MANUFACTURER
Covidien LP (formerly Nellcor Puritan Bennett Inc.) Boulder, CO on 3/16/2016. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
1,864 units
DISTRIBUTION
Nationwide and Internationally
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