CareFusion Alaris PC Unit with Software V9.12: Class 1 Recall
MedSun: Newsletter #84, May 2013

FDA MedWatch Safety Alert

When the Alaris PC unit experiences a communication error, the programmed infusion(s) will continue as programmed. However, no further key presses on the Alaris PC unit have an effect on the system except for the System On key which allows the user to power down the device. Powering down of the device results in termination of all infusions. Termination of an infusion could result in serious injury or death.

Additional Information:

FDA MedWatch Safety Alert. CareFusion Alaris PC Unit with Software V9.12: Class 1 Recall. April 22, 2013.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm349002.htm


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