# China NMPA Product Recall - Radiation Therapy Planning System

Source: https://www.globalkeysolutions.net/records/china_product_recall/philips-medical-systen-cleveland-inc/cd7f25be-d60a-410b-b373-cb0c7eaeb1cd/
Source feed: China

> China NMPA product recall for Radiation Therapy Planning System by Philips Medical Systen (Cleveland) Inc. published September 24, 2025. Recall level: Level 3 Recall. Philips Medical Systems (Cleveland), Inc. has initiated a voluntary Level III recall of its Radiatio

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Philips Medical Systems (Cleveland), Inc. is voluntarily recalling its radiotherapy planning software.
- Company Name: Philips Medical Systen (Cleveland) Inc.
- Publication Date: 2025-09-24
- Product Name: Radiation Therapy Planning System
- Recall Level: Level 3 Recall
- Recall Reason: Products containing the TumorLOC module may cause the expected ROI to shift when performing advanced region of interest (ROI) expansion and contraction.
- Discovering Company: Philips (China) Investment Co., Ltd.
- Manufacturing Company: Philips Medical Systen (Cleveland) Inc.
- Summary: 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.

Company: https://www.globalkeysolutions.net/companies/philips-medical-systen-cleveland-inc/ed7d764b-6bff-4901-aefb-c49a08c8414f/