China NMPA Product Recall - Radiation Therapy Planning System

Philips Medical Systems (Cleveland), Inc. has initiated a voluntary Class III recall for its Radiation Therapy Planning System software. This action, reported by Philips (China) Investment Co., Ltd., was publicly announced by the National Medical Products Administration (NMPA) on September 5, 2025. The primary concern is a software malfunction that potentially impairs the accurate generation of the stop power ratio, consequently resulting in incorrect dataset calculations crucial for precise radiation therapy planning. This device is registered under National Medical Device Registration Certificate 20153213194, falling under the NMPA's regulatory framework for medical device safety and quality. The company is undertaking this recall to address the identified software deficiency and mitigate potential risks to patient care and treatment efficacy. Further detailed information, including specific product models, specifications, and batch numbers impacted by this recall, is available in the "Medical Device Recall Event Report Form" provided by Philips. This demonstrates the manufacturer's commitment to ensuring the reliability and safety of its medical devices, proactively addressing software-related issues.