China NMPA Product Recall - Clinical monitors, patient monitors

Edwards Lifesciences LLC initiated a voluntary Level I recall of its clinical and patient monitors, reported on September 18, 2019, under the National Medical Products Administration (NMPA) framework. The recall addresses a significant safety issue concerning the potential for excessive liquid to seep into the equipment, which could cause electrical short circuits. This defect poses a serious risk, leading to the highest classification of recall.

The affected products include specific models of clinical patient monitors (Registration Certificate Nos.: 20173212327, 20133211526) and patient monitors (Registration Certificate No.: 20163215108). This regulatory action requires the company to remove all impacted devices from the market to prevent potential harm to patients. Detailed information regarding the specific models, specifications, and batches of the recalled products is available in the official "Medical Device Recall Event Report Form," ensuring transparency and comprehensive handling of the issue. This proactive measure by Edwards Lifesciences LLC, in coordination with the NMPA, underscores a commitment to patient safety and adherence to strict medical device regulations.