China NMPA Product Recall - Patient Monitor

On April 16, 2019, Philips (China) Investment Co., Ltd. initiated a voluntary Level II recall for its Patient Monitor, specifically targeting MX40 models with software revision B. This action was prompted by identified performance issues related to the devices' battery system. The main concern is an elevated battery power consumption, which causes a substantial reduction in the monitors' operational duration; affected MX40 units experience approximately 25% less battery life than specified in the instruction manual. Critically, these devices also fail to issue a low battery alarm as intended, potentially compromising timely user intervention. This issue impacts both rechargeable and disposable battery operations. The National Medical Products Administration (NMPA) and the Shanghai Food and Drug Administration are overseeing this recall. Philips (China) has detailed the affected models, specifications, and batch numbers in a 'Medical Device Recall Event Report Form' to facilitate this necessary corrective action for the registered medical device 20173216825, prioritizing patient safety.