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Terminated

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.

FDA Recall Z-0611-2014 · Posted 2014-01-03

Recalling FirmCovidien
Recall StatusTerminated
Product CodeCBK
Date Initiated2013-12-16
Date Terminated2016-11-29
Product Quantity16,923 US, 39,372 OUS

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.

Firm 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.

Root Cause

Software design

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K053388MODEL 840 VENTILATOR WITH PROPORTIONAL ASSIST VENTILATION PLUS SOFTWARE OPTIONPuritan Bennett Corp. · 2006-04-04K020357800 SERIES EASYNEB NEBULIZERNellcor Puritan Bennett, Inc. · 2002-08-07K001646PURITAN-BENNETT 840 VENTILATOR SYSTEM WITH NEOMODE OPTIONPuritan Bennett Corp. · 2000-10-20K993071PURITAN-BENNETT VENTILATOR SYSTEM WITH ET/TRACHEOSTOMY TUBE COMPENSATION, TC, OPTION, MODEL 840Puritan Bennett Corp. · 1999-11-24K984535PURITAN-BENNETT 840 VENTILATORY SYSTEM WITH BILEVEL OPTIONPuritan Bennett Corp. · 1998-12-28K970460NELLCOR PURITAN BENNETT, 840 VENTILATOR SYSTEM (MODEL 840)Puritan Bennett Corp. · 1998-04-30

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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