China NMPA Product Recall - Patient monitor; clinical monitor

Edwards (Shanghai) Medical Supplies Co., Ltd. initiated a voluntary recall of its EV1000A patient monitors and clinical monitors, as detailed in a National Medical Products Administration (NMPA) publication dated September 6, 2019. This recall, an update to an earlier report from March 15, 2019, was prompted by a small number of overseas complaints. The primary issue identified was the potential for liquid to enter the AC power socket of the EV1000A model, attributed to incorrect installation of the AC power cord during use. This ingress of liquid could lead to electrical short circuits. Consequently, the company escalated the recall to a Class I level, indicating a high risk of serious adverse health consequences or death. The regulatory framework overseeing this action includes the NMPA and the Shanghai Food and Drug Administration. As a required action, Edwards (Shanghai) Medical Supplies Co., Ltd. expanded its corrective measures, further detailing affected product models, specifications, and batches in an attached Medical Device Recall Event Report Form. The company emphasized its commitment to addressing the safety concern through this comprehensive recall.