China NMPA Product Recall - ECG leads

On March 18, 2020, GE Healthcare Systems Trading Development (Shanghai) Co., Ltd. initiated a voluntary Class III recall of specific batches of its manufactured ECG leads. This action, reported by the Shanghai Municipal Drug Administration and overseen by the National Medical Products Administration (NMPA), was prompted by recent findings indicating a critical safety concern. The primary issue identified is that if a patient is connected to an affected ECG main cable and leads during defibrillation, the energy delivered by the defibrillator may be significantly reduced. This reduction in energy output poses a direct risk of decreasing the success rate of defibrillation, which is a life-saving procedure. The company specified that the affected products are ECG leads, identified under Registration Certificate No.: 国械备20190172号. The regulatory framework governing this recall is the NMPA, which categorizes the recall as Class III, signifying a situation where use of or exposure to a violative product is not likely to cause adverse health consequences. GE Healthcare Systems Trading Development (Shanghai) Co., Ltd. is taking the required action of voluntarily recalling the implicated medical devices to mitigate potential patient harm and ensure device efficacy. Detailed information on the specific models, specifications, and batch numbers involved is available in the accompanying "Medical Device Recall Event Report Form."