Recall Z-1181-2016 ยท CBK Ventilator, Continuous, Facility Use
Covidien LP (formerly Nellcor Puritan Bennett Inc.)
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.
| Date | Mar 17, 2016 (initiated Jan 15, 2016) |
| Status | Terminated |
| 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. |
| Root cause | Under Investigation by firm |
| Action | Customers were notified via an Urgent Medical Device Safety Notification, dated February 8, 2016, on 1/14/16. The letter identified the affected device and the issues involved. Consignees are requested to forward the recall letter to anyone they may have transferred or assigned for use one of the potentially affected ventilators. Medtronic is investigating the root cause of these conditions and will provide a service update to resolve the issues as soon as corrections can be implemented. Customers are to complete the attached form and return it per the instructions to confirm receipt and u |
| Quantity | 1,864 units |
| Distribution | Worldwide Distribution -- US, including but not limited to the territory of Puerto Rico; and Ireland, Jordan, Saudi Arabia, Bahrain, Australia, Japan, Israel, Turkey, Chile, South Africa, Costa Rica, United Arab Emirates, Qatar, Peru, Panama, Singapore, Kuwait, Lebanon, Brazil, Mexico, Colombia, Ru |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K131252 | PURITAN BENNETT 980 SERIES VENTILATOR SYSTEM Covidien, Feb 24, 2014 |