China NMPA Product Recall - Patient monitor

Philips (China) Investment Co., Ltd. initiated a voluntary Level III recall of its MX40 patient monitors (models 865351, 865352), as announced by the National Medical Products Administration (NMPA) on December 11, 2018. This action follows the Shanghai Food and Drug Administration Medical Device Recall 2018-285. The recall addresses a critical issue where, during operation at altitudes exceeding 4500 feet (1372 meters), the device's speaker volume may become reduced or completely inaudible. This defect impacts products manufactured between February 21, 2017, and August 22, 2018, posing a significant safety risk if medical personnel cannot hear essential alarms or alerts. The company has taken responsibility for identifying and addressing this performance deviation under the NMPA's regulatory oversight. The recall mandates the retrieval of all affected units, with detailed information on specific models, specifications, and batches provided in the accompanying "Recall Event Report Form." This proactive measure aims to mitigate potential patient safety concerns stemming from compromised audible alerts in high-altitude clinical settings.