# China NMPA Product Recall - Radiation Therapy Planning System

Source: https://www.globalkeysolutions.net/records/china_product_recall/philips-medical-systen-cleveland-inc/cb6586d9-a176-4aa0-bf02-50442d9624a1/
Source feed: China

> China NMPA product recall for Radiation Therapy Planning System by Philips Medical Systen (Cleveland) Inc. published September 05, 2025. Recall level: Level 3 Recall. Philips Medical Systems (Cleveland), Inc. has initiated a voluntary Class III recall for its Radiati

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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: 2025-09-05
- Product Name: Radiation Therapy Planning System
- Recall Level: Level 3 Recall
- Recall Reason: Due to a potential software issue affecting the generation of the execution stop power ratio, the dataset calculation was incorrect.
- Discovering Company: Philips (China) Investment Co., Ltd.
- Manufacturing Company: Philips Medical Systen (Cleveland) Inc.
- Summary: 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.

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