Puritan Bennett 980 Ventilator System, PB980 Ventilator (980xxxxxxxx). Intended to provide continuous ventilation for pe

FDA device recall Z-1181-2016 · posted 2016-03-17 · Terminated

Recall details

Recalling firm

Covidien LP (formerly Nellcor Puritan Bennett Inc.)

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.

Action taken

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 understanding of the information. Questions or issues should be directed to the Technical Support Department at 800-255-6774.

Root cause

Under Investigation by firm

Status

Terminated

Product code

CBK

Quantity affected

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,

Date initiated

2016-01-15

Date posted

2016-03-17

Date terminated

2017-07-11

Location

Boulder, CO

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