China NMPA Product Recall - MX40 Patient Monitor

Philips (China) Investment Co., Ltd., acting for Philips Medical Systems, initiated a voluntary Level II recall for its MX40 Patient Monitors (models 865351, 865352). This action, reported on September 21, 2016, and published by the National Medical Products Administration (NMPA) on December 7, 2016, addresses a critical software defect. The core issue is that if the factory default "Alarms On" setting is modified on the MX40, it inadvertently disables ECG alarm generation and transmission to the Philips IntelliVue Information Center X (PIIC iX). Crucially, the PIIC iX fails to display that these alarms are disabled, posing a significant patient safety risk. Although the PIIC iX system is not currently used in China, Philips proactively recalled 150 affected units sold there to prevent future hazards. The required corrective actions involve Philips (China) issuing Field Safety Notifications to customers and providing complimentary software upgrades for the affected MX40 patient monitors to restore proper functionality and ensure patient safety.