CareFusion Cortical Stimulator Control Unit: Class I Recall - Software Malfunction and Short Circuit
MedSun: Newsletter #70, March 2012

FDA MedWatch Safety Alert

The device's software incorrectly indicates stimulation is delivered to a different electrode than the one selected and a short circuit may develop between the cortical stimulator control unit and the stimulus switching unit amplifier. Both of these issues may result in the surgeon resecting the wrong brain tissue. The surgeon may also fail to resect pathological tissue, potentially leading to continued pathologic processes and the need for re-operations.

Additional Information:

FDA MedWatch Safety Alert. CareFusion Cortical Stimulator Control Unit: Class 1 Recall - Software Malfunction and Short Circuit. February 23, 2012.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm292975.htm


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