CareFusion is updating their recall of the Nicolet Cortical Stimulator Control Unit, Nicolet C64 Stimulus Switching Unit (SSU) Amplifier, and the NicoletOne Software with Cortical Stimulator License. The recall, originally made in October 2011, affects 125 devices and 58 software licenses that were distributed to 38 customers between May 7, 2009 and July 11, 2011. The recall has no effect on the manufacture or distribution of current products.
In October 2011, an urgent Medical Device Recall Notification was issued to customers advising that a potential risk had been identified in the Cortical Stimulator Control Unit, SSU Amplifier and related software applications. The units affected by the recall have the potential to develop a short circuit, and affected software licenses may display or capture the incorrect electrode annotation label on the unit screen and in the associated report.