China NMPA Product Recall - Patient monitor

Philips (China) Investment Co., Ltd. announced a voluntary Class III recall of certain patient monitors, as reported to the National Medical Products Administration (NMPA) on August 9, 2019. The manufacturer, Philips Medical Systems, identified a critical quality control issue: the connector thickness on these medical devices potentially exceeds specified engineering values. This non-conformance represents a deviation from established product specifications and could impact device performance or patient safety, prompting the company's proactive intervention. The recall, documented under NMPA Index No.: JGXX-2019-10517, pertains to patient monitors with Registration Certificate No.: 20153212166. While a Class III recall indicates a situation where use of or exposure to a violative product is not likely to cause adverse health consequences, Philips is undertaking this action to uphold its commitment to product quality and patient safety. The company is required to meticulously identify, retrieve, and manage all affected units, detailing specific product models, specifications, and batch numbers in a 'Medical Device Recall Event Report Form.' This action underscores adherence to NMPA's stringent regulatory framework for medical devices in China, ensuring that products on the market meet all prescribed safety and performance standards.