Alerta De Seguridad para Nicolet® Cortical Stimulator Control Unit, Nicolet® C64 Stimulus Switching Unit (SSU) Amplifier and NicoletOne Software with Cortical Stimulator License

Safety alert

2012-01-26

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20120126c.html

Field safety notice: recall of carefusion nicolet® cortical stimulator control unit, nicolet® c64 stimulus switching unit (ssu) amplifier and nicoletone software with cortical stimulator license medical device manufacturer, carefusion corporation, is conducting a voluntary recall of nicolet® cortical stimulator control unit, nicolet® c64 stimulus switching unit (ssu) amplifier and nicoletone software with cortical stimulator license. carefusion has 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. the united states food and drug administration (fda) has classified this action as a class i recall. according to the local supplier, the affected products are not distributed in hong kong. for details, please refer to the fda website: http://www.Fda.Gov/safety/recalls/ucm288493.Htm if you are in possession of the affected products, please contact your supplier for necessary actions.