Recall Z-1058-2015 ยท CBK Ventilator, Continuous, Facility Use
Covidien LP (formerly Nellcor Puritan Bennett Inc.)
Puritan Bennett 980 Ventilator System, Model No. PB980 Ventilator (980xxxxxxxx), The Puritan BennettTM 980 Ventilator System is designed for use on Neonatal (NICU) through Adult patient populations who require respiratory support or mechanical ventilation and weigh a minimum of 0.3 kg (0.66 lb). It is suitable for service in a hospital (institutions) and intra-hospital transport to provide cont
| Date | Feb 5, 2015 (initiated Jan 12, 2015) |
| Status | Terminated |
| Reason | Covidien is issuing a voluntary field action for all Puritan Bennett 980 ventilators due to occasional GUI transient resets that last approximately 30 seconds. |
| Root cause | Software design |
| Action | Covidien sent an Urgent Field Safety Notice on January 12, 2015, to all affected customers. Customers were requested to forward the recall letter to anyone they may have transferred or assigned for use one of the potentially affected ventilators. Covidien is updating software that will modify ventilator alarms and status display messages during a GUI reset. The Puritan Bennett 980 Ventilator Operator Manual will be updated to delete,replace ventilator during a GUI transient reset, and to inform users to monitor the secondary status display until the primary display refreshes. Covidien will co |
| Quantity | 418 units |
| Distribution | Worldwide Distribution - USA (nationwide) and Internationally to Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K131252 | PURITAN BENNETT 980 SERIES VENTILATOR SYSTEM Covidien, Feb 24, 2014 |