Recall Z-0112-2015 ยท CBK Ventilator, Continuous, Facility Use
Nellcor Puritan Bennett Inc. (dba Covidien LP)
Covidien Puritan Bennett 980 Ventilator, Rx ONLY. Suitable for service in a hospital (institutions) and intra-hospital transport to provide continuous positive pressure ventilator for Neonatal (NICU) through Adult patient populations.
| Date | Oct 28, 2014 (initiated Oct 1, 2014) |
| Status | Terminated |
| Reason | A software issue may lead to ventilator inoperative situations. |
| Root cause | Software design |
| Action | The firm sent Urgent: Field Correction Action letters, dated October 3, 2014, to consignees. The letter identified the affected product and the reason for the recall. Customers were provided actions to be taken, as well as, important safety reminders. The letter informed customers that they may continue to use their ventilators pending the software correction as long as two gas sources are connected to the ventilator at all times. Customers are to complete the attached acknowledgement and receipt form and fax it to Covidien at the number provided. For further assistance, customers are to |
| Quantity | 324 units |
| Distribution | Worldwide Distribution -- USA, including the states of CA, CO, FL, GA, KY, MA, MN, NC, NY, OH, OK, PA, SC, TN, TX, UT, WI; and, the countries of Canada, Mexico, Saudi Arabia, South Africa, and United Arab Emirates. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K131252 | PURITAN BENNETT 980 SERIES VENTILATOR SYSTEM Covidien, Feb 24, 2014 |