China NMPA Product Recall - Cerebral cortex stimulator

The National Medical Products Administration (NMPA) publicized on December 13, 2011, a voluntary recall initiated by CareFusion 209, Inc. for its Nicolet Cortical Stimulators. Reported by CareFusion (Shanghai) Trading Co., Ltd., the recall addressed a software issue where electrode annotations displayed incorrectly on screens and in reports when utilizing NicoletOne software versions v5.6.0-5.71.4, despite correct current delivery during cortical stimulation. This presented a potential for misinterpretation during patient treatment. The recall commenced on November 7, 2011, and was slated for completion by December 15, 2011. CareFusion's corrective actions included immediately ceasing sales of affected units, notifying all customers, and providing direct support. This support encompassed supplying updated NicoletOne software (v5.71.5) and a replacement cortical stimulator control unit. Company personnel conducted on-site visits to customers for installation of the new software and hardware, device calibration, and relabeling. CareFusion 209, Inc. (USA) assumed responsibility for managing the returned recalled products. The NMPA urged provincial Food and Drug Administrations to enhance supervision over such medical devices.