China NMPA Product Recall - Patient monitors (models: MX40, 865351, 865352)

Philips (China) Investment Co., Ltd. has initiated a voluntary Class III recall for specific MX40 patient monitors, models 865351 and 865352. This recall was officially reported on December 5, 2018, under the regulatory oversight of the National Medical Products Administration (NMPA), specifically referenced by the Shanghai Food and Drug Administration Medical Device Recall 2018-285. The core issue involves a critical defect where the speaker volume on the affected monitors may become significantly reduced or completely inaudible when operating at altitudes above 4500 feet (1372 meters). This directly impacts the device's ability to effectively deliver audible alerts, which is crucial for patient monitoring and safety. The products subject to this recall were manufactured between February 21, 2017, and August 22, 2018. As a required action under the NMPA's framework, Philips (China) Investment Co., Ltd. is responsible for systematically recalling all identified units to mitigate potential risks associated with unheeded alarms and to ensure the devices meet their intended performance specifications in all specified operating environments. This voluntary recall underscores the company's commitment to product safety and regulatory compliance.