Puritan Bennett 840 ventilator systems software recall: Software Issue
Puritan Bennett 840 ventilator systems software part number 4-070212-85, revision AB-AG. The intended use of the product is to provide mechanical…
Why was Puritan Bennett 840 ventilator systems software recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Software Part number 4-070212-85, revision AB-AG
- 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…
- Recalling firm
- Covidien
- Quantity
- 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 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.
- Recall date
- January 15, 2014
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (device)