China NMPA Product Recall - Patient monitor, patient monitoring device

GE Healthcare Systems Trading Development (Shanghai) Co., Ltd. initiated a voluntary Class III recall of multiple patient monitor models, as announced by the National Medical Products Administration (NMPA) on October 18, 2018. This action, identified under NMPA Index No. JGXX-2018-11225 and Shanghai Food and Drug Administration Medical Device Recall 2018-206, addresses a significant product performance issue. The primary concern is that patient monitors may automatically restart when multiple devices are connected to the same network, particularly if the network experiences prolonged overload. A more critical issue arises when network problems persist, causing the patient monitors to enter a continuous restart loop. The affected devices include patient monitors with CFDA Import Registration Numbers 20073211603, 20103211865, 20093210393, and 20103211878. Further details regarding specific specifications and batches are contained within the "Medical Device Recall Event Report Form." This voluntary recall underscores the company's commitment to ensuring the safety and reliable operation of its medical equipment in accordance with regulatory requirements.