Puritan Bennett 980 Ventilator System, Model No. PB980 Ventilator (980xxxxxxxx), The Puritan BennettTM 980 Ventilator Sy

FDA device recall Z-1058-2015 · posted 2015-02-05 · Terminated

Recall details

Recalling firm

Covidien LP (formerly Nellcor Puritan Bennett Inc.)

Reason for recall

Covidien is issuing a voluntary field action for all Puritan Bennett 980 ventilators due to occasional GUI transient resets that last approximately 30 seconds.

Action taken

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 communicate with customers when the software and operator manual updates are available. Customers with questions were instructed to contact Technical Support Department at 800-255-6774, option 4, and then option 1. For questions regarding this recall call 303-876-8870.

Root cause

Software design

Status

Terminated

Product code

CBK

Quantity affected

418 units

Distribution

Worldwide Distribution - USA (nationwide) and Internationally to Canada.

Date initiated

2015-01-12

Date posted

2015-02-05

Date terminated

2016-01-06

Location

Boulder, CO

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