Puritan Bennett 840 ventilator systems software part number 4-070212-85, revision AB-AG. The intended use of the product

FDA device recall Z-0611-2014 · posted 2014-01-03 · Terminated

Recall details

Recalling firm

Covidien

Reason for recall

Covidien is conducting a voluntary field corrective action on Puritan Bennett 840 ventilator systems with certain software revisions in response to customer reports of ventilator diagnostic code XB0069 in which the device stops mechanical ventilation due to a software error.

Action taken

Covidien sent an Urgent Medical Device Voluntary Field Correction letter to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to continue using their Puritan Bennett 840 ventilators until it is feasible to install the software update discussed in the letter. Covidien has developed a software solution to address this issue. Upon availability, there will be several ways to install the software update. To initiate the process for updating your software and to select the method that best suits your facility, please visit our software update management portal at www.PB840technicalupdate.com and follow the instructions to register your ventilators. If you need further assistance contact our Technical Support Department @ 1-800-255-6774, option 4, then option 1. For questions regarding this recall call 800-255-6774.

Root cause

Software design

Status

Terminated

Product code

CBK

Quantity affected

16,923 US, 39,372 OUS

Distribution

Worldwide Distribution - USA (nationwide) and Internationally to Austria, Estonia, Belgium, Spain, Italy, Poland, Bulgaria, Finland, Portugal, Switzerland, France, Lithuania, Romania, Cyprus, Great Br

Date initiated

2013-12-16

Date posted

2014-01-03

Date terminated

2016-11-29

Location

Boulder, CO

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