Recall Z-1181-2016— Covidien LP (formerly Nellcor Puritan Bennett Inc.)
Class II · Terminated
Class II FDA medical device recall by Covidien LP (formerly Nellcor Puritan Bennett Inc.), initiated 2016-01-15, terminated 2017-07-11. It names one FDA 510(k) clearance: K131252. 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..
- Recalling firm
- Covidien LP (formerly Nellcor Puritan Bennett Inc.)
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-01-15
- Terminated
- 2017-07-11
- Firm location
- Boulder, CO, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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 for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.