China NMPA Product Recall - Radiation Therapy Planning System

Philips Medical Systems (Cleveland), Inc. has initiated a voluntary Level III recall of its Radiation Therapy Planning System software. This action, reported by Philips (China) Investment Co., Ltd. and published by the National Medical Products Administration (NMPA) on September 24, 2025, addresses a critical product issue. The recall specifically concerns products incorporating the TumorLOC module, which has been identified as potentially causing an unintended shift in the expected Region of Interest (ROI) during high-level expansion and contraction procedures. This type of deviation in ROI could have significant implications for patient treatment accuracy. The manufacturer is taking this proactive step to ensure patient safety and product reliability, adhering to the NMPA's regulatory framework for medical device recalls. Detailed information regarding the affected software models, specifications, and batch numbers is available in the accompanying 'Medical Device Recall Event Report Form.' This recall underscores the company's commitment to correcting product deficiencies and maintaining compliance with medical device regulations.