# China NMPA Product Recall - Medical Angiography X-ray System

Source: https://www.globalkeysolutions.net/records/china_product_recall/philips-medical-systems/80df9793-31b8-44e1-94ce-3c414ad2ef00/
Source feed: China

> China NMPA product recall for Medical Angiography X-ray System by Philips Medical Systems published October 18, 2024. Recall level: Level 3 Recall. Philips Medical Systems Nederland B.V., through its subsidiary Philips (China) Investment Co., Ltd.,

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Philips Medical Systems Nederland B.V. has initiated a voluntary recall of products including medical angiography X-ray systems.
- Company Name: Philips Medical Systems
- Publication Date: 2024-10-18
- Product Name: Medical Angiography X-ray System
- Recall Level: Level 3 Recall
- Recall Reason: The technical data in the product instruction manual and technical documents are inconsistent.
- Discovering Company: Philips (China) Investment Co., Ltd.
- Manufacturing Company: Philips Medical Systems
- Summary: Philips Medical Systems Nederland B.V., through its subsidiary Philips (China) Investment Co., Ltd., initiated a voluntary Level III recall of its Medical Angiography X-ray systems. The recall was publicly announced on October 18, 2024. The primary reason for this action was the discovery of inconsistencies in the technical data presented in the product instructions and associated technical documents for these medical devices. This issue necessitated the recall to ensure product information accuracy and compliance. The recall affects specific registered medical device models (e.g., 20203060323, 20193060314, etc.) within the Chinese market, although certain models, specifications, and batches were not imported into China. This action falls under the regulatory oversight of the National Medical Products Administration (NMPA) of China. The company is required to manage the recall process, including providing detailed information in a "Medical Device Recall Event Report Form," to address the identified discrepancies and maintain regulatory standards.

Company: https://www.globalkeysolutions.net/companies/philips-medical-systems/91e33b43-88a2-4a53-9bcd-1d32f1abde47/