FDAFDA · Food and drugs·Recall number Z-0611-2014
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.
Published January 15, 2014 · Recall initiated: December 16, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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 to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Covidien
- Distributor
- 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
- Software Part number 4-070212-85, revision AB-AG
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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