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.
This recall has been terminated (originally issued January 3, 2014).
- Company
- Covidien
- Recall Initiated
- December 16, 2013
- Posted
- January 3, 2014
- Terminated
- November 29, 2016
- Recall Number
- Z-0611-2014
- Quantity
- 16,923 US, 39,372 OUS
- Firm Location
- Boulder, CO
- Official Source
- View on FDA website ↗
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.
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.
Lot / Code Info
Software Part number 4-070212-85, revision AB-AG
Root Cause
Software design
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.