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U.S. Department of Health and Human Services

Class 1 Device Recall Puritan Bennett 840 ventilator systems software

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 Class 1 Recall
Puritan Bennett 840 ventilator systems software
see related information
Date Posted January 03, 2014
Recall Status1 Open
Recall Number Z-0611-2014
Recall Event ID 67108
Premarket Notification
510(K) Numbers
K001646  K020357  K053388  K063650  K083693  K092847 
K970460  K984535  K993071 
Product Classification Ventilator, Continuous, Facility Use - Product Code CBK
Product Puritan Bennett 840 ventilator systems software part number 4-070212-85, revision AB-AG. The intended use of the product is to provide mechanical ventilation to patients.
Code Information Software Part number 4-070212-85, revision AB-AG
Recalling Firm/
6135 Gunbarrel Ave
Boulder, Colorado 80301-3214
For Additional Information Contact Covidien Technical Services
Manufacturer 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.
FDA Determined
Cause 2
DESIGN: Software Design
Action 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.
Quantity in Commerce 16,756 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 Britain, Czech Republic, Greece, Latvia, Slovenia, Germany, Hungary, Slovak Republic, Ireland, Netherlands, Turkey, Croatia, Andorra, Albania, Algeria, Bahrain, Bosnia and Herzegovina, Egypt, Georgia, Iran, Iraq, Israel, Jordan, Kenya, Kuwait, Lebanon, Libya, Macedonia, Montenegro, Morocco, Russia, Saudi Arabia, Serbia, South Africa, Syria, Sudan, Tunisia, UAE, Uganda, Puerto Rico, Mexico, Columbia, Chile, Brazil, Argentina, Uruguay, Panama, Costa Rica, Peru, China, Korea, Japan, Taiwan, Hong Kong, Malaysia, Singapore, Sri Lanka, Australia, New Zealand.
Total Product Life Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = CBK and Original Applicant = COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT INC.
510(K)s with Product Code = CBK and Original Applicant = COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT, INC.
510(K)s with Product Code = CBK and Original Applicant = NELLCOR PURITAN BENNETT, INC.
510(K)s with Product Code = CBK and Original Applicant = PURITAN BENNETT CORP.