China NMPA Product Recall - External defibrillator monitor

Philips Kinco (Shenzhen) Industrial Co., Ltd. initiated a voluntary Class II recall of its Efficia DFM100 external defibrillator monitors, as announced by the National Medical Products Administration (NMPA) on April 19, 2021. The recall stems from the company's discovery that the device may generate a low battery warning due to voltage surges occurring during battery insertion or removal. This critical issue poses a risk of delaying or preventing essential medical treatment for patients. The affected devices carry Registration Certificate No.: 20183080392. While the document does not specify inspection dates, the recall was voluntarily initiated by Philips Kinco upon identification of the defect. The NMPA's involvement highlights its role in overseeing medical device safety and public health, operating under a framework that requires manufacturers to address product deficiencies. As part of the corrective actions, Philips Kinco (Shenzhen) Industrial Co., Ltd. is recalling the specified models. Further details regarding the affected product models, specifications, and serial numbers are available in the accompanying "Medical Device Recall Event Report Form" and multiple appendices listing affected domestic units. This proactive measure aims to mitigate potential patient harm and ensure the reliability of these life-saving medical devices.