CareFusion Corporation Alaris PC Units (Model 8015): Recall - Potential for Delay or Interruption of Therapy
MedSun: Newsletter #54, November 2010

FDA MedWatch Safety Alert

Under certain wireless network conditions, a communication error can occur, which freezes the PC Unit screen. This error may result in a delay of therapy and inability to make programming changes to current infusions. If users experience the problem, they are to remove the device from service and contact the CareFusion Recall Center immediately. The corrective action will require a hardware update to all affected units. CareFusion does not require that the devices be returned.

Additional Information:

FDA MedWatch Safety Alert. CareFusion Corporation Alaris PC Units (Model 8015): Recall - Potential for Delay or Interruption of Therapy. October 15, 2010.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm229767.htm


MedSun Newsletters are available at www.fda.gov/cdrh/medsun