Recall Z-0180-2015 ยท CBK Ventilator, Continuous, Facility Use
Nellcor Puritan Bennett Inc. (dba Covidien LP)
Covidien Puritan Bennett 980 Ventilator, Rx ONLY, Made in Ireland., Covidien LLC, USA. REF 980X1ENDIUU.
| Date | Dec 9, 2014 (initiated Oct 1, 2014) |
| Status | Terminated |
| Reason | Covidien is recalling certain Puritan Bennett 980 Ventilator Systems due to a blacklight inverter PCBA where a capacitor component can fail, causing a dim but functional screen and thermal odor. |
| Root cause | Device Design |
| Action | Update: Consignees were notified on 12/11/14 of strategy change after Covidien sent an Urgent Field Safety Corrective Action notification with instructions dated September 2014 via traceable courier to affected consignees. The letter identifed the affected product, problem and actions to be taken. Consignees were instructed to complete the attached verification form and fax it to the Covidien RMS contact indicated on the form. If you need further assistance, contact the Technical Support Department @ 1-800-255-6774, option 4, then option 1. |
| Quantity | 324 units |
| Distribution | Worldwide Distribution-US (nationwide) including the states of CA, CO, FL, GA, KY, MA, MN, NC, NY, OH, OK, PA, SC, TN, TX, UT, and 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 |