CareFusion voluntarily recalled its Nicolet® Cortical Stimulator Control Unit, Nicolet® C64 Stimulus Switching Unit (SSU) Amplifier in October of 2011. It was considered a Class 1 recall, which means there is a reasonable probability of serious adverse health consequences or death associated with use of the defective units.
In October 2011, the CareFusion sent an urgent Medical Device Recall Notification to the healthcare providers it sold the product to, stating the identified potential risks associated with the Cortical Stimulator Control Unit, SSU Amplifier and related software applications. Affected units have the potential to develop a short circuit, and affected software licenses may display or capture the incorrect electrode annotation label on the Cortical Stimulator Control Unit screen and in the associated report. In short, the information the product was giving to medical providers about their patients brain activity was inaccurate.
A defective product such as this can create catastrophic consequences for consumers. If you have any questions about this defective product or Class One recalls contact Wade Yeoman at 502-882-6000 or email him at wade@jonesward.com
