China NMPA Product Recall - Electrophysiological recording system

GE Healthcare Trading Development (Shanghai) Co., Ltd., operating under the regulatory framework of the National Medical Products Administration (NMPA), issued a voluntary recall for specific electrophysiological recording and hemodynamic monitoring systems. The affected products, manufactured by GE Medical Systems, include models like Cardiolab EP 2000, EP 4000, EP 7000, Mac-Lab, ComboLab, and Cardiolab II Plus amplifier systems. The primary reason for this action was the omission of certain critical checks during maintenance procedures in India. Importantly, the company confirmed that none of the recalled devices were sold in China; the recall's scope is exclusively limited to units distributed in India, and no injuries have been reported. The required action involves a comprehensive re-maintenance for all identified affected products in India to rectify the missed checks. The NMPA, in its oversight capacity, urged local food and drug administrations to reinforce supervision of similar medical devices.